Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2025 I, Avinash Clarke, as delegate of the Minister for Health and Aged Care, make the following determination. Dated 24 February 2025 Avinash Clarke Assistant Secretary Complementary and Over the Counter Medicines Branch Health Products Regulation Group Department of Health and Aged Care Contents 1 Name 2 Commencement 3 Authority 4 Interpretation 5 Permissible ingredients 6 Requirements in relation to permissible ingredients being contained in medicine 6A Requirements relating to warning statements on labels 7 Repeals Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine Note: This instrument is in 6 volumes: Volume 1: Sections 1–7 (pages 2-4) Schedule 1 (+-)-NARINGENIN–AZULENE Volume 2: Schedule 1 BACILLUS COAGULANS–EVERNIA PRUNASTRI EXTRACT Volume 3: Schedule 1 FABIANA IMBRICATA–JUSTICIA ADHATODA Volume 4: Schedule 1 KADSURA COCCINEA–OYSTER SHELL Volume 5: Schedule 1 P-ALPHA-DIMETHYL STYRENE–TYROSINE Volume 6: Schedule 1 UBIDECARENONE–ZOSTERA MARINA 1 Name This instrument is the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2025. 2 Commencement (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms. Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. The whole of this instrument 1 March 2025. 1 March 2025 Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument. (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument. 3 Authority This instrument is made under subsection 26BB(1) of the Therapeutic Goods Act 1989. 4 Interpretation Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following: (a) British Pharmacopoeia; (b) European Pharmacopoeia; (c) medicine; (d) Register; (e) United States Pharmacopeia-National Formulary. (1) In this instrument: Act means the Therapeutic Goods Act 1989. active ingredient, or A, for a medicine, has the same meaning as in the Regulations. code tables means the tables accessed via the Code Tables item in the Public TGA Information menu in TGA eBusiness Services. excipient or E, for a medicine, means an ingredient that is not an active ingredient or a homoeopathic preparation ingredient. Note: An excipient includes an ingredient that provides flavour, fragrance or colour to the medicine. homoeopathic preparation has the same meaning as in the Regulations. homoeopathic preparation ingredient or H, means an ingredient that is a constituent of a homoeopathic preparation. Regulations means the Therapeutic Goods Regulations 1990. TGA eBusiness Services means TGA eBusiness Services on the Therapeutic Goods Administration website, which may be accessed on the internet at www.ebs.tga.gov.au. Therapeutic Goods Administration has the same meaning as in the Regulations. (2) To avoid doubt, the terms set out in closed brackets in column 4 of the table in Schedule 1, which are associated with warning statements in relation to particular ingredients, are: (a) terms from the code tables under the heading Product Warning; and (b) not required to be reproduced in a warning statement on the label of a medicine. Note: Examples of these terms include the following: (a) (ARGIN1); (b) (CHILD3); (c) (GLUTEN); (d) (PEANUT); (e) (PREGNT). 5 Permissible ingredients The ingredients specified in column 2 of the table in Schedule 1 are specified for the purposes of paragraph 26BB(1)(a) of the Act. 6 Requirements in relation to permissible ingredients being contained in medicine For an ingredient mentioned in column 2 of an item in the table in Schedule 1, the following requirements are specified for the purposes of paragraph 26BB(1)(b) of the Act: (a) the ingredient must only be used in a medicine for a purpose specified in relation to the ingredient in column 3 of that item; and (b) subject to section 6A, the ingredient must comply with the requirements specified in relation to the ingredient in column 4 of that item; and (c) if the ingredient is derived from animal originthe safety of the ingredient must have been assessed against, and comply with, the principles and requirements in the European Pharmacopoeia general monograph 1483 Products with risk of transmitting agents of animal spongiform encephalopathies, including General Text 5.2.8: Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products. 6A Requirements relating to warning statements on labels Where more than one ingredient in a medicine (the relevant ingredients) must comply with a requirement, specified in column 4 of the table in Schedule 1 in relation to the ingredient, that a warning statement must be stated on the medicine label (the specified warning statement) in the form of either: (a) 'In [rare/very rare] cases, [ingredient] may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching'; or (b) 'In [rare/very rare] cases, [ingredient] may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine'; the warning statement may be stated only once on the label of the medicine (the combined warning statement), provided that: (c) the combined warning statement lists all the relevant ingredients; and (d) if the specified warning statement for at least one of the relevant ingredients includes the words 'in rare cases'—the combined warning statement includes the words 'in rare cases' instead of the words 'in very rare cases'; and (e) if the specified warning statement for at least one of the relevant ingredients is in the form mentioned in paragraph (a)—the combined warning statement must be in the form mentioned in paragraph (a). 7 Repeals The Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2024 is repealed. Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine Note: See sections 5 and 6. Permissible ingredients and requirements Column 1 Column 2 Column 3 Column 4 Item Ingredient name Purpose Specific requirements 1 (+-)-NARINGENIN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2 (-)-MENTHYL METHYL ETHER E (-)-Menthyl methyl ether must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing (-)-menthyl methyl ether must not be more than 5% of the total medicine. When the medicine is for internal use, the maximum recommended daily dose of the medicine must not provide more than 53 micrograms of (-)-menthyl methyl ether. 3 (1,7,7-TRIMETHYLBICYCLO(2.2.1)HEPT-2-YL)-CYCLOHEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4 (1R,2S,5R)-N-(4-METHOXYPHENYL)-5-METHYL-2-(1-METHYLETHYL) CYCLOHEXANECARBOXAMIDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in the medicine must be no more than 5%. 5 (5E)-3-METHYL-5-CYCLOTETRADECEN-1-ONE E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 6 (5Z)-3-METHYL-5-CYCLOTETRADECEN-1-ONE E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 7 (E)-2-(3,5-DIMETHYLHEX-3-EN-2-YLOXY)-2-METHYLPROPYL CYCLOPROPANECARBOXYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 8 (E)-3-METHYLCYCLOPENTADEC-5-EN-1-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 9 (E, E)-2,6-NONADIENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 10 (R)-ALPHA-TERPINYL ACETATE E (R)-alpha-terpinyl acetate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing (R)-alpha-terpinyl acetate must not be more than 1% of the total medicine. 11 (S)-LACTIC ACID A, E, H 12 (S)-S-ADENOSYLMETHIONINE DISULFATE DITOSYLATE DIHYDRATE A (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine disulfate ditosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 13 (S)-S-ADENOSYLMETHIONINE DISULFATE TOSYLATE A (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine disulfate tosylate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 14 (S)-S-ADENOSYLMETHIONINE DISULFATE TRITOSYLATE DIHYDRATE A (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine disulfate tritosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 15 (S)-S-ADENOSYLMETHIONINE HEXASULFATE DIHYDRATE A (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine hexasulfate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 16 (S)-S-ADENOSYLMETHIONINE HEXATOSYLATE DIHYDRATE A (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine hexatosylate dihydrate and must be declared in the application. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 17 (S)-S-ADENOSYLMETHIONINE PENTASULFATE DIHYDRATE A (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine pentasulfate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: -(SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 18 (S)-S-ADENOSYLMETHIONINE PENTATOSYLATE DIHYDRATE A (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine pentatosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 19 (S)-S-ADENOSYLMETHIONINE TETRASULFATE DIHYDRATE A (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine tetrasulfate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 20 (S)-S-ADENOSYLMETHIONINE TETRATOSYLATE DIHYDRATE A (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine tetratosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 21 (S)-S-ADENOSYLMETHIONINE TRISULFATE DITOSYLATE DIHYDRATE A (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine trisulfate ditosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 22 (Z)-HEX-3-ENYL 2-ETHYLBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 23 (Z, Z)-3,6-NONADIEN-1-OL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 24 1,2,3,4,4A,5,8,8A-OCTAHYDRO-2,2,6,8-TETRAMETHYL-1-NAPHTHALENOL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%. 25 1,2-HEXANEDIOL E Only for use in topical medicines for dermal application and not to be included in topical products intended for use in the eye. The concentration in the medicine must be no more than 1%. 26 1,3,4,6,7,8A-HEXAHYDRO-1,1,5,5-TETRAMETHYL-2H-2,4A-METHANONAPHTHALEN-8(5H)-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 27 1,3,5-UNDECATRIENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 28 1,3-BUTYLENE GLYCOL E 29 1,3-NONANEDIOL ACETATE, MIXED ESTERS E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 30 1,3-NONANEDIOL, DIACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 31 1,4-CINEOLE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1% 32 1,4-DIOXACYCLOHEXADECANE-5,16-DIONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 33 1,5,9-TRIMETHYL-13-OXABICYCLO[10.1.0]TRIDECA-4,8-DIENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 34 1,7,7-TRIMETHYLBICYCLO[4.4.0]DECAN-3-YL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 35 1,8,12-BISABOLATRIENE E 1,8,12-bisabolatriene must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing 1,8,12-bisabolatriene must not be more than 5% of the total medicine. 36 1-(2,2,6-TRIMETHYLCYCLOHEXYL)-3-HEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 37 1-(2,6,6-TRIMETHYL-2-CYCLOHEXEN-1-YL)-1-PENTEN-3-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 38 1-(3,3-DIMETHYLCYCLOHEXYL)ETHYL FORMATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 39 1-(4-ISOPROPYLCYCLOHEXYL)ETHANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 40 1-(5,5-DIMETHYL-1-CYCLOHEXEN-1-YL)-4-PENTEN-1-ONE E If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. Permitted for use only in combination with other permitted ingredients as a fragrance. 41 1-DODECANOL E Permitted for use: (a) only in combination with other permitted ingredients as a flavour; and (b) in topical medicines for dermal application. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 42 1-HEPTANOL E 1-heptanol must only be included in medicines when in combination with other permitted ingredients as a flavour or a fragrance proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing 1-heptanol must not be more than 5% of the total medicine. The total concentration of fragrance proprietary excipient formulations containing 1-heptanol must not be more than 1% of the total medicine. 43 1-HEXEN-3-OL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 44 1-METHOXY-4-PROPENYLBENZENE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 45 1-METHYL-2-[(1,2,2-TRIMETHYLBICYCLO[3.1.0]HEX-3-YL)METHYL]-CYCLOPROPANEMETHANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 46 1-METHYL-3-(2-METHYLPROPYL)-CYCLOHEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 47 1-METHYL-4-(4-METHYL-3-PENTENYL)-3-CYCLOHEXENE-1-CARBOXALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 48 1-OCTEN-3-ONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 49 1-P-MENTHENE-8-THIOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 50 1-PENTEN-3-OL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 51 10-UNDECEN-1-OL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 52 10-UNDECENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 53 16-HYDROXY-12-OXAHEXADECANOIC ACID, OMEGA-LACTONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 54 2'-FUCOSYLLACTOSE A The route of administration for medicines that contain 2'-fucosyllactose must be limited to oral. Lactose is a mandatory component of 2'-fucosyllactose. The maximum recommended daily dose of the medicine must not provide more than: a) 12 g of 2'-fucosyllactose to individuals aged 13 years and older; b) 4 g of 2'-fucosyllactose to individuals aged between 1 and 12 years (inclusive); and c) 1.2 g of 2'-fucosyllactose to individuals aged between 1 and 11 months (inclusive). 2'-fucosyllactose is not permitted for use in children under the age of 1 month. One of the following statements is required on the medicine label: a) When the medicine is only for use in individuals aged above 2 years: 'Not to be taken on the same day with other products containing 2'-fucosyllactose' (or words to that effect); or b) When the medicine is for use in individuals up to and including 2 years of age: 'Not to be taken on the same day with breastmilk or other products containing 2'-fucosyllactose' (or words to that effect). 55 2,2'-METHYLENEBIS(4-METHYL-6-TERT-BUTYLPHENOL) E 2,2'-methylenebis(4-methyl-6-tert-butylphenol) must only be included in medicines when in combination with other permitted ingredients as a proprietary excipient formulation in medicines with a dermal route of administration for topical application. 56 2,2,3-TRIMETHYLCYCLOPENT-3-ENE-1-ETHYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 57 2,2,5-TRIMETHYL-5-PENTYLCYCLOPENTANONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 58 2,2-DIMETHYL-3-(3-METHYL-2,4-PENTADIENYL)-OXIRANE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 59 2,2-DIMETHYL-3-PHENYLPROPANOLL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 60 2,2-DIMETHYL-5-(1-METHYLPROPEN-1-YL) TETRAHYDROFURAN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 61 2,2-DIMETHYL-P-ETHYLPHENYL-PROPANENITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 62 2,3,4-TRIMETHYL-3-PENTANOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 63 2,3,5,6-TETRAMETHYLPYRAZINE E If used in a flavour the total flavour concentration in a medicine must be no more than 5%. Permitted for use only in combination with other permitted ingredients as a flavour. 64 2,3,5-TRIMETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 65 2,3-DIETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. 66 2,3-DIHYDRO-1,1-DIMETHYL-1H-INDENE-AR-PROPANAL E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient. The total fragrance proprietary excipient formulation concentration in a medicine must not be more than 1%. 67 2,3-DIHYDRO-2,5-DIMETHYL-1H-INDENE-2-METHANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 68 2,3-DIMETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 69 2,3-HEXADIONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 70 2,3-HEXANEDIONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 71 2,3-PENTANEDIONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 72 2,4,5-TRIMETHYLTHIAZOLE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 73 2,4,6-TRIMETHYL-4-PHENYL-1,3-DIOXANE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 74 2,4-DECADIENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in the medicine must be no more than 1%. The maximum daily dose must provide no more than 3 mg of 2,4-Decadienal. 75 2,4-DIMETHYL BUTADIENEACROLEIN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 76 2,4-DIMETHYL THIAZOLE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 77 2,4-DIMETHYL-3-CYCLOHEXENE CARBOXALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 78 2,4-DIMETHYL-4,4A,5,9B-TETRAHYDROINDENO[1,2-D]-1,3-DIOXIN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 79 2,4-DIMETHYL-4-PHENYL TETRAHYDROFURAN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 80 2,4-HEPTADIENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in the medicine must be no more than 1%. The maximum daily dose must provide no more than 3 mg of 2,4-Heptadienal. 81 2,4-HEXADIENOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in the medicine must be no more than 1%. The maximum daily dose must provide no more than 13.5 mg of 2,4-Hexadienol. 82 2,5-DIETHYLTETRAHYDROFURAN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 83 2,5-DIMETHYL-2-OCTEN-6-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 84 2,5-DIMETHYL-4-ETHOXY-3(2H)-FURANONE E Only for use in medicines in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must not be more than 5%. 85 2,5-DIMETHYL-4-HYDROXY-3(2H)-FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour or fragrance. If used in a flavour the total flavour concentration in the medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 86 2,5-DIMETHYL-4-METHOXY-3(2H)-FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 87 2,5-DIMETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance, or a printing ink. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. If used in a printing ink the total printing ink concentration in a medicine must be no more than 0.1% 88 2,6,6,TRIMETHYL-2-CYCLOHEXENE-1,4-DIONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 89 2,6,9,10-TETRAMETHYL-1-OXASPIRO(4.5)DECA-3,6-DIENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 90 2,6-DIMETHOXYPHENOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 91 2,6-DIMETHYL HEPTAN-2-OL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 92 2,6-DIMETHYL-2-HEPTENAL-(7) E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 93 2,6-DIMETHYL-3,5-OCTADIEN-2-OL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 94 2,6-DIMETHYL-4-HEPTYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 95 2,6-DIMETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 96 2,6-NONADIEN-1-OL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 97 2,6-OCTADIENOIC ACID, 3,7-DIMETHYL-, METHYL ESTER, (2E)- E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 98 2-(1,1-DIMETHYLETHYL)-1,4-DIMETHOXY-BENZENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 99 2-(2-(4-METHYL-3-CYCLOHEXEN-1-YL)PROPYL CYCLOPENTANONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 100 2-(2-METHYLPHENYL)ETHANOL E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The ingredient is not to be included in medicines intended for use in the eye. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 101 2-(4-METHYLPHENOXY)-N-1H-PYRAZOL-3-YL-N-(2-THIENYLMETHYL)ACETAMIDE E The route of administration of a medicine containing 2-(4-methylphenoxy)-n-1h-pyrazol-3-yl-n-(2-thienylmethyl)acetamide must be limited to dental. The total concentration of 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)acetamide in the medicine must not be more than 0.015%. 2-(4-Methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)acetamide must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation The total concentration of flavour proprietary excipient formulations containing 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)acetamide must not be more than 5% of the total medicine. 102 2-(6-METHYL-8-ISOPROPYL BICYCLO(2.2.2)OCT-5-ENE-2-YL-1,3-DIOXOLANE E 2-(6-methyl-8-isopropyl bicyclo(2.2.2)oct-5-ene-2-yl)-1,3-dioxolane must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 2-(6-methyl-8-isopropyl bicyclo(2.2.2)oct-5-ene-2-yl)-1,3-dioxolane must not be more than 1% of the total medicine. 103 2-[(3,7-DIMETHYL-6-OCTEN-1-YLIDENE)AMINO]BENZOIC ACID, METHYL ESTER E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 104 2-[1-(3,3-DIMETHYLCYCLOHEXYL)ETHOXY]-2-METHYLPROPYL] CYCLOPROPANECARBOXYLATE E If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. Permitted for use only in combination with other permitted ingredients as a fragrance. 105 2-[1-(3,3-DIMETHYLCYCLOHEXYL)ETHOXY]-2-OXOETHYL PROPANOATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 106 2-ACETYLFURAN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 107 2-ACETYLPYRAZINE E If used in a flavour the total flavour concentration in a medicine must be no more than 5%. Permitted for use only in combination with other permitted ingredients as a flavour. 108 2-ACETYLPYRIDINE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 109 2-AMINO-2-METHYL-1-PROPANOL E Only for use in topical medicines for dermal application. 110 2-BENZYL-4,4,6-TRIMETHYL-1,3-DIOXANE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 111 2-BUTEN-1-OL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 112 2-BUTYL-4,4,6-TRIMETHYL-1,3-DIOXANE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 113 2-CYCLOHEXYLIDENE-2-O-TOLYL-ACETONITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 114 2-DECENAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 115 2-DODECANOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 116 2-DODECENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 117 2-ETHOXY-4-(METHOXYMETHYL)-PHENOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 118 2-ETHOXY-9-METHYLENE-2,6,6-TRIMETHYLBICYCLO[3.3.1]NONANE E 2-ethoxy-9-methylene-2,6,6-trimethylbicyclo[3.3.1]nonane must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 2-ethoxy-9-methylene-2,6,6-trimethylbicyclo[3.3.1]nonane must not be more than 1% of the total medicine. 119 2-ETHOXYETHANOL E The residual solvent limit for 2-Ethoxyethanol is 1.6 mg per maximum recommended daily dose. The concentration in the medicine must be no more than 0.016%. 120 2-ETHYL-1-HEXANOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 121 2-ETHYL-3,5-DIMETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 122 2-ETHYL-3,6-DIMETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 123 2-ETHYL-3-METHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 124 2-ETHYL-4-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)-2-BUTEN-1-OL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 125 2-ETHYL-4-HYDROXY-5-METHYL-3(2H)-FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 126 2-ETHYL-4-METHYLTHIAZOLE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 127 2-ETHYL-ALPHA,ALPHA-DIMETHYL-BENZENEPROPANAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 128 2-ETHYL-N-METHYL-N-(3-METHYLPHENYL) BUTANAMIDE E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%. 129 2-ETHYLBUTYRIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 130 2-HEPTANOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 131 2-HEPTANONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 132 2-HEPTYL CYCLOPENTANONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 133 2-HEXENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 134 2-HYDROXYACETOPHENONE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 1%. 135 2-ISOBUTYL-3-METHOXYPYRAZINE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 136 2-ISOBUTYL-4-METHYLTETRAHYDRO-2H-PYRAN-4-OL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 137 2-ISOPROPOXYETHYL SALICYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 138 2-ISOPROPYL-4-METHYLTHIAZOLE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 139 2-ISOPROPYLPHENOL E 2-Isopropylphenol must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing 2-isopropylphenol must not be more than 5% of the total medicine. 140 2-MERCAPTOPROPIONIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 141 2-METHOXY-3-(1-METHYLPROPYL)PYRAZINE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 142 2-METHOXY-4-VINYLPHENOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 143 2-METHYL HEPTANOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 144 2-METHYL-2-PENTENOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 145 2-METHYL-2-VINYL-5-ISOPROPENYLTETRAHYDROFURAN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 146 2-METHYL-3-(3,4-METHYLENEDIOXYPHENYL)PROPANAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 147 2-METHYL-3-(4-METHOXYPHENYL)PROPANAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 148 2-METHYL-3-[4-(2-METHYLPROPYL)PHENYL]PROPANAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 149 2-METHYL-3-BUTEN-2-OL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 150 2-METHYL-3-FURANTHIOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 151 2-METHYL-4-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)BUTANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 152 2-METHYL-4-(2,2,3-TRIMETHYL-3-CYCLOPENTENYL)-2-BUTEN-1-OL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. Only for use in topical medicines for dermal application. 153 2-METHYL-4-(2,2,3-TRIMETHYLCYCLOPENT-3-EN-1-YL)PENT-4-EN-1-OL E 2-Methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-1-ol must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-1-ol must not be more than 1% of the total medicine. 154 2-METHYL-4-(2,6,6-TRIMETHYL-1-CYCLOHEXEN-1-YL)-2-BUTENAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 155 2-METHYL-4-(CAMPHENYL-8)-CYCLOHEXANONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 156 2-METHYL-4-PROPYL-1,3-OXTHIANE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 157 2-METHYL-5-(METHYLTHIO)FURAN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 158 2-METHYL-5-PHENYLPENTANOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 159 2-METHYLBUTYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 160 2-METHYLBUTYL ISOVALERATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 161 2-METHYLBUTYL PHENYLETHYL ETHER E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 162 2-METHYLBUTYL SALICYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 163 2-METHYLDECANAL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%. 164 2-METHYLHEXANOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 165 2-METHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 166 2-METHYLTETRAHYDROFURAN-3-ONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 167 2-METHYLUNDECANAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 168 2-METHYLVALERIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 169 2-NONENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 170 2-NONENENITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 171 2-OXOBUTYRIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 172 2-PENTADECANONE E Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. 173 2-PENTANOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 174 2-PENTANONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 175 2-PENTENAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 176 2-PENTYL FURAN E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 177 2-PHENYLPROPIONALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 178 2-PHENYLPROPIONALDEHYDE DIMETHYL ACETAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 179 2-PROPENOIC ACID E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 180 2-SEC-BUTYL CYCLOHEXANONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 181 2-TERT-BUTYLCYCLOHEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 182 2-TERT-BUTYLCYCLOHEXYLOXY-2-BUTANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 183 2-TRANS-6-CIS-NONADIENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 184 2-TRIDECANONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 185 2-TRIDECENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 186 2-TRIDECENENITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 187 2-UNDECENAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 188 3'-SIALYLLACTOSE SODIUM A Lactose and sodium are mandatory components of 3'-sialyllactose sodium. The route of administration for medicines that contain 3'-sialyllactose sodium must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than: (a) 0.2 g 3'-sialyllactose sodium in infants under 12 months; (b) 0.15 g 3'-sialyllactose sodium in children aged 12-35 months; or (c) 0.5 g 3'-sialyllactose sodium in individuals aged 3 years and older. 189 3,3-DIMETHYL-5-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)-4-PENTEN-2-OL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 190 3,3-DIMETHYLACRYLIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 191 3,4,4A,5,8,8A-HEXAHYDRO-3',7-DIMETHYLSPIRO-1,4-METHANONAPHALENE-2(1H),2'-OXIRANE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 192 3,4-DIMETHYL PHENYLACETALDEHYDE E 3,4-Dimethyl phenylacetaldehyde must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 3,4-dimethyl phenylacetaldehyde must not be more than 1% of the total medicine. 193 3,4-DIMETHYL-1,2-CYCLOPENTADIONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 194 3,5,5-TRIMETHYL HEXANAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 195 3,5,5-TRIMETHYLHEXYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 196 3,5,6,6-TETRAMETHYL-4-METHYLENEHEPTAN-2-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 197 3,5-DIMETHOXYTOLUENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 198 3,5-DIMETHYL-3-CYCLOHEXENE-1-CARBOXALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 199 3,6-DIMETHYL-3-CYCLOHEXENE-1-CARBOXALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 200 3,7-DIMETHYL OCTANAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 201 3,7-DIMETHYL-1-OCTANOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 202 3,7-DIMETHYL-1-OCTEN-3-OL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%. 203 3,7-DIMETHYL-2,6-NONADIENENITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 204 3,7-DIMETHYL-2,6-OCTADIENAL REACTION PRODUCTS WITH ETHANOL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%. 205 3,7-DIMETHYL-7-METHOXYOCTAN-2-OL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 206 3-(1-BUTENYL)-PYRIDINE E 3-(1-Butenyl)-pyridine must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 3-(1-butenyl)-pyridine must not be more than 1% of the total medicine. 207 3-(3-ISOPROPYLPHENYL)BUTANAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 208 3-(4-ETHYLPHENYL)-2,2-DIMETHYLPROPANAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 209 3-(4-HYDROXYPHENYL)-1-(2,4,6-TRIHYDROXYPHENYL)-1-PROPANONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 210 3-(4-TERT-BUTYLPHENYL)-PROPANAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 211 3-(ISO-CAMPHYL-5)-CYCLOHEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 212 3-(METHYLTHIO) PROPIONALDEHYDE E 3-(Methylthio) propionaldehyde must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing 3-(methylthio) propionaldehyde must not be more than 5% of the total medicine. 213 3-(METHYLTHIO)-1-HEXYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 214 3-CARENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 215 3-DODECENAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 216 3-ETHYLPYRIDINE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 217 3-FUCOSYLLACTOSE A Lactose is a mandatory component of 3-fucosyllactose. The route of administration for medicines that contain 3-fucosyllactose must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than: (a) 2 g of 3-fucosyllactose to individuals aged 0 to 3 years (inclusive); and (b) 5 g of 3-fucosyllactose to individuals aged 4 years and older. One of the following statements is required on the medicine label: (i) When the medicine is only for use in individuals aged 2 years and above: 'Not to be taken on the same day with other products containing 3-fucosyllactose' (or words to that effect); or (ii) When the medicine is for use in children aged less than 2 years: 'Not to be taken on the same day with breastmilk, or other products containing 3-fucosyllactose' (or words to that effect). 218 3-HEPTYLDIHYDRO-5-METHYL-2(3H)-FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 219 3-HEXANONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 220 3-HEXEN-1-OL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 221 3-ISO-CAMPHYL-5-CYCLOHEXAN-1-OL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 222 3-METHYL THIOPROPIONALDEHYDE ETHANOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 223 3-METHYL-2-(PENTYLOXY)CYCLOPENT-2-EN-1-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 224 3-METHYL-5-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)-4-PENTEN-2-OL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 225 3-METHYL-5-PHENYL PENT-2-ENENITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 226 3-METHYL-5-PHENYLPENTANAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 227 3-METHYL-5-PHENYLPENTANENITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 228 3-METHYL-5-PHENYLPENTANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 229 3-METHYL-5-PROPYL-2-CYCLOHEXEN-1-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 230 3-METHYLCYCLOPENTADECANONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 231 3-METHYLCYCLOPENTADECENONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 232 3-METHYLPENTANOIC ACID E 3-Methylpentanoic acid must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of the flavour proprietary excipient formulation containing 3-methylpentanoic acid must not be more than 5% of the total medicine. 233 3-METHYLTHIOHEXANOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 234 3-OCTANOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 235 3-OCTYL ACETATE E Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. 236 3-PENTYLTETRAHYDRO-2H-PYRAN-4-OL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 237 3-PHENYLPROPIONALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 238 3-PHENYLPROPYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 239 3-PHENYLPROPYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 240 3-PROPYLIDENE PHTHALIDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 241 3-TRANS-ISOCAMPHYLCYCLOHEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 242 3A,6,6,9A-TETRAMETHYLDODECAHYDRONAPHTHO[2,1-B] FURAN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 243 4,4A,5,9B-TETRAHYDRO-2,4-DIMETHYL-INDENO(1,2-D)-1,3-DIOXIN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 244 4,4A,5,9B-TETRAHYDROINDENO(1,2-D)-1,3-DIOXIN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 245 4,5-DIMETHYL-3-HYDROXY-2(5H)FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 246 4,7-METHANO-1H-INDENEMETHANOL, OCTAHYDRO-, ACETATE E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 247 4,7-METHANO-3A,4,5,6,7,7A-HEXAHYDRO-5 (OR 6) -INDENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 248 4,8-DIMETHYL-3,7-NONADIEN-2-OL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 249 4-(1-ETHOXYVINYL)-3,3,5,5-TETRAMETHYLCYCLOHEXANONE E 4-(1-Ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone must not be more than 1% of the total medicine. 250 4-(4-METHYL-3-PENTEN-1-YL)-3-CYCLOHEXENE-1-CARBOXALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 251 4-(5,5,6-TRIMETHYLBICYCLO(2.2.1)HEPT-2-YL)-CYCLOHEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 252 4-(METHYLTHIO)-4-METHYL-2-PENTANONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 253 4-(OCTAHYDRO-4,7-METHANO-5H-INDEN-5-YLIDENE)-BUTANAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 254 4-(PARA-HYDROXYPHENYL)-2-BUTANONE E 4-(para-hydroxyphenyl)-2-butanone must only be included in medicines when: (a) in combination with other permitted ingredients as a flavour proprietary excipient formulation; (b) in combination with other permitted ingredients as a fragrance proprietary excipient formulation; and/or (c) in topical medicines for dermal application that are not intended for use in the eye or on damaged skin. The total concentration of flavour proprietary excipient formulations containing 4-(para-hydroxyphenyl)-2-butanone must not be more than 5% of the total medicine. The total concentration of fragrance proprietary excipient formulations containing 4-(para-hydroxyphenyl)-2-butanone must not be more than 1% of the total medicine. The concentration of 4-(para-hydroxyphenyl)-2-butanone in a topical medicine for dermal application must not be more than 1% of the total medicine. 255 4-(PARA-METHOXYPHENYL)-2-BUTANONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 256 4-ACETYL-6-TERTIARY-BUTYL-1,1-DIMETHYLINDAN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 257 4-CYCLOHEXYL-2-METHYL-2-BUTANOL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%. 258 4-ETHYL GUAIACOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 259 4-HEPTANONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. 260 4-HYDROXYBENZALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 261 4-HYDROXYBENZYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 262 4-ISOPROPYL-3-METHYLPHENOL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 263 4-METHOXY-2-METHYL-2-BUTANETHIOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 264 4-METHYL-3-DECEN-5-OL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 265 4-METHYL-4-MERCAPTOPENTAN-2-ONE E If used in a flavour the total flavour concentration in a medicine must be no more than 5%. Permitted for use only in combination with other permitted ingredients as a flavour. 266 4-METHYL-4-PHENYL-2-PENTYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 267 4-METHYL-5-THIAZOLETHANOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 268 4-METHYLBENZYLIDENE CAMPHOR A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 4%. The following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 269 4-METHYLPENTANOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 270 4-METHYLPHENYL OCTANOATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 271 4-PARA METHOXYPHENYL-3-BUTANONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 272 4-PENTENOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 273 4-TERT-BUTYL-2,6-DIMETHYL ACETOPHENONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 274 4-TERT-BUTYLCYCLOHEXANOL E Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.1%. 275 4-TERT-PENTYLCYCLOHEXANONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 276 5,6,7,8-TETRAHYDROQUINOXALINE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 277 5,7-DIHYDRO-2-METHYLTHIENO (3,4D) PYRIMIDINE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 278 5-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)-3-METHYLPENTAN-2-OL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 279 5-ACETYL-1,1,2,3,3,6-HEXAMETHYL INDAN E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 280 5-CYCLOHEXADECEN-1-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 281 5-ETHYL-2,3-DIMETHYLPYRAZINE E 5-Ethyl-2,3,dimethylpyrazine must not be included in medicines for oral administration. 5-Ethyl-2,3,dimethylpyrazine must only be included in topical medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 5-ethyl-2,3,dimethylpyrazine must not be more than 1% of the total medicine. 282 5-ETHYL-3-HYDOXY-4-METHYL-2(5H)-FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 283 5-ETHYL-4-HYDROXY-2-METHYL-3(2H)-FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 284 5-HYDROXY-4-METHYLHEXANOIC ACID DELTA-LACTONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 285 5-METHOXYPSORALEN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 286 5-METHYL 2-PHENYL HEXEN-2-AL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 287 5-METHYL-2-THIOPHENE CARBOXALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 288 5-METHYL-3-BUTYLTETRAHYDROPYRAN-4-YL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 289 5-METHYL-3-HEPTANONE OXIME E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 290 5-PENTYL-2(5H)-FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 291 6'-SIALYLLACTOSE SODIUM A Lactose and sodium are mandatory components of 6'-sialyllactose sodium. The route of administration for medicines that contain 6'-sialyllactose sodium must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than: (a) 0.4 g 6'-sialyllactose sodium in infants under 12 months; (b) 0.3 g 6'-sialyllactose sodium in children aged 12-35 months; or (c) 1.0 g 6'-sialyllactose sodium in individuals aged 3 years and older. 292 6,6-DIMETHOXY-2,5,5-TRIMETHYL-2-HEXENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 293 6,6-DIMETHYL-2-NORPINENEPROPIONALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 294 6,7-DIHYDRO-1,1,2,3,3-PENTAMETHYL-4(5H)-INDANONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 295 6-BUTYL-3,6-DIHYDRO-2,4-DIMETHYL-2H-PYRAN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 296 6-ETHYLIDENEOCTAHYDRO 5,8-METHANO-2H-1-BENZOPYRAN E 6-Ethylideneoctahydro 5,8-methano-2H-1-benzopyran must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 6-ethylideneoctahydro 5,8-methano-2H-1-benzopyran must not be more than 1% of the total medicine. 297 6-METHOXY-2,6-DIMETHYLHEPTAN-1-AL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 298 6-METHOXYDICYCLOPENTADIENECARBOXALDEHYDE E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. When included in a medicine for use on the lips the concentration of 6-methoxydicyclopentadiene carboxaldehyde must be no more than 0.1%. When included in dermal creams for infant use the concentration of 6-methoxydicyclopentadienecarboxaldehyde must be no more than 0.5%. When for dermal use or use on the hair the concentration of 6-methoxydicyclopentadienecarboxaldehyde must be no more than 0.5%. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 299 6-METHYL COUMARIN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 300 6-METHYLQUINOLINE E 6-Methylquinoline must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of the flavour proprietary excipient formulation containing 6-methylquinoline must not be more than 5% of the total medicine. 301 7-ACETYL-1,1,3,4,4,6-HEXAMETHYL TETRAHYDRONAPHTHALENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 302 7-METHYL-2H-1,5-BENZODIOXEPIN-3(4H)-ONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 303 7-OCTENE-1,6-DIOL, 3,7-DIMETHYL- E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 304 7-PROPYL-2H-1,5-BENZODIOXEPIN-3(4H)-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 305 8,13:13,20-DIEPOXY-14,15-BISNORLABDANE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 306 8-METHYL-1-OXASPIRO(4,5)DECAN-2-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 307 8-OCIMENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 308 9-DECEN-1-OL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 309 ABELMOSCHUS MOSCHATUS A, H 310 ABELMOSCHUS MOSCHATUS SUBSP. MOSCHATUS A, H 311 ABIES BALSAMEA A, H 312 ABIES NIGRA A, H 313 ABIES PECTINATA A, H 314 ABIES SIBIRICA A, H 315 ABRUS CANTONIENSIS A, H If the herbal substance is derived from the seed, the maximum recommended daily dose of Abrus cantoniensis must be no more than 1mg of the dry seed. 316 ABUTILON THEOPHRASTI A, H 317 ACACIA A, E, H 318 ACACIA BAILEYANA A, H 319 ACACIA CATECHU A, H 320 ACACIA DEALBATA A, H 321 ACACIA DECURRENS E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 322 ACACIA FARNESIANA E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 323 ACACIA LONGIFOLIA A, E, H 324 ACACIA NILOTICA A, E, H 325 ACACIA SENEGAL A, E, H 326 ACALYPHA INDICA A, H 327 ACANTHUS MOLLIS A, H 328 ACER CAMPESTRE A, H 329 ACER NEGUNDO A, H 330 ACER SACCHARINUM A, H 331 ACER SACCHARUM A, E, H 332 ACEROLA E 333 ACESULFAME POTASSIUM E 334 ACETAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 335 ACETALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 336 ACETALDEHYDE ETHYL LINALYL ACETAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 337 ACETALDEHYDE ETHYL PHENYLETHYL ACETAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 338 ACETALDEHYDE PHENYLETHYL PROPYL ACETAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 339 ACETANISOLE E Permitted for use only: (a) in topical medicines for dermal application; and (b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. 340 ACETIC ACID E, H The concentration in the medicine must be no more than 80%. 341 ACETOIN E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 342 ACETOMENAPHTHONE A, E 343 ACETONE E The residual solvent limit for Acetone is 50 mg per maximum recommended daily dose. The concentration in the medicine must be no more than 0.5%. 344 ACETOPHENONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 345 ACETOVANILLONE E Only for use in topical medicines for dermal application. Permitted for use only in combination with other permitted ingredients as a fragrance. If used as a fragrance the total fragrance concentration in a medicine must be no more than 1%. 346 ACETOXYDIHYDRODICYCLOPENTADIENE E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%. 347 ACETYL DIPEPTIDE-1 CETYL ESTER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.01%. 348 ACETYL GLUCOSAMINE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 349 ACETYL HEXAMETHYL TETRALIN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 350 ACETYL LEVOCARNITINE HYDROCHLORIDE A, E 351 ACETYL TRIFLUOROMETHYLPHENYL VALYLGLYCINE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 352 ACETYLATED LANOLIN E Only for use in topical medicines for dermal application. 353 ACETYLATED LANOLIN ALCOHOL E Only for use in topical medicines for dermal application. 354 ACETYLATED MONOGLYCERIDES E 355 ACETYLATED VETIVER OIL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 356 ACETYLCYSTEINE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.001%. 357 ACHILLEA ERBA-ROTTA SUBSP. MOSCHATA A, H 358 ACHILLEA MILLEFOLIUM A, E, H Beta-arbutin is a mandatory component of Achillea millefolium. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 359 ACHILLEA PTARMICA A, H 360 ACHYRANTHES ASPERA A, H 361 ACHYRANTHES BIDENTATA A, H 362 ACHYRANTHES FAURIEI A, H 363 ACID GREEN 25 E Permitted for use only as a colour for topical use. 364 ACID RED 33 E Permitted for use only as a colour for topical use. 365 ACID RED 87 E, H Only for use as an active homoeopathic ingredient or for excipient use as a colour in topical medicines. 366 ACID TREATED WAXY MAIZE STARCH E 367 ACID-ISOMERISED LINALOOL E Permitted for use only when combined with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 368 ACONITUM CARMICHAELII A, H Total alkaloids (of Aconitum spp.) is a mandatory component of Aconitum carmichaelii. The maximum amount of total alkaloids (of Aconitum spp.) must be no more than 0.02 milligrams per pack. 369 ACONITUM FEROX A, H Total alkaloids (of Aconitum spp.) is a mandatory component of Aconitum ferox. The maximum amount of total alkaloids (of Aconitum spp.) must be no more than 0.02 milligrams per pack. 370 ACONITUM KUSNEZOFFI A, H Total alkaloids (of Aconitum spp.) is a mandatory component of Aconitum kusnezoffii. The maximum amount of total alkaloids (of Aconitum spp.) must be no more than 0.02 milligrams per pack. 371 ACONITUM NAPELLUS A, H Total alkaloids (of Aconitum spp.) is a mandatory component of Aconitum napellus. The maximum amount of total alkaloids (of Aconitum spp.) must be no more than 0.02 milligrams per pack. 372 ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.7%. 373 ACRYLAMIDES COPOLYMER E Only for use in topical medicines for dermal application. 374 ACRYLATES COPOLYMER E Only for use in topical medicines for dermal application. 375 ACRYLATES/ACRYLAMIDE COPOLYMER E Only for use in topical medicines for dermal application. 376 ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER E Only for use in topical medicines for dermal application. 377 ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 378 ACRYLATES/DIMETHICONE COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 379 ACRYLATES/OCTYLACRYLAMIDE COPOLYMER E Only for use in topical medicines for dermal application. 380 ACRYLATES/STEARETH-20 METHACRYLATE COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 381 ACRYLATES/VA COPOLYMER E Only for use in topical medicines for dermal application. 382 ACRYLIC ACID/VP CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2.5%. 383 ACTAEA CIMICIFUGA A, H 384 ACTAEA HERACLEIFOLIA A, H 385 ACTAEA PACHYPODA A, H 386 ACTAEA RACEMOSA A, H When used in oral medicines, the medicine requires the following warning statement on the medicine label: - (BCOHOSH) 'Warning: In very rare cases - black cohosh has been associated with liver failure. If you are experiencing yellowing of the skin or whites of the eyes - dark urine - nausea - vomiting - unusual tiredness - weakness - stomach or abdominal pain - and/or loss of appetite - you should stop using this product and see your doctor.' 387 ACTAEA SIMPLEX A, H 388 ACTAEA SPICATA A, H 389 ACTINIDIA CHINENSIS A, H 390 ACTINIDIA DELICIOSA A, H 391 ACTIVATED ATTAPULGITE A When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 392 ACTIVATED CHARCOAL A, E, H When for internal use, the medicine requires the following warning statement on the medicine label: - (ACCOAL) 'Products containing activated charcoal should be used with caution in children since it may interfere with absorption of nutrients. Activated charcoal may interact with other medicines. Activated charcoal is not recommended for long-term use' (or words to that effect). 393 ADEMETIONINE DISULFATE DITOSYLATE DIHYDRATE A, H (S)-S-Adenosylmethionine is a mandatory component of Ademetionine disulfate ditosylate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 394 ADEMETIONINE DISULFATE TOSYLATE A, H (S)-S-Adenosylmethionine is a mandatory component of Ademetionine disulfate tosylate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 395 ADEMETIONINE DISULFATE TRITOSYLATE DIHYDRATE A, H (S)-S-Adenosylmethionine is a mandatory component of Ademetionine disulfate tritosylate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 396 ADEMETIONINE HEXASULFATE DIHYDRATE A, H (S)-S-Adenosylmethionine is a mandatory component of Ademetionine hexasulfate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 397 ADEMETIONINE HEXATOSYLATE DIHYDRATE A, H (S)-S-Adenosylmethionine is a mandatory component of Ademetionine hexatosylate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 398 ADEMETIONINE PENTASULFATE DIHYDRATE A, H (S)-S-Adenosylmethionine is a mandatory component of Ademetionine pentasulfate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 399 ADEMETIONINE PENTATOSYLATE DIHYDRATE A, H (S)-S-Adenosylmethionine is a mandatory component of Ademetionine pentatosylate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 400 ADEMETIONINE TETRASULFATE DIHYDRATE A, H (S)-S-Adenosylmethionine is a mandatory component of Ademetionine tetrasulfate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 401 ADEMETIONINE TETRATOSYLATE DIHYDRATE A, H (S)-S-Adenosylmethionine is a mandatory component of Ademetionine tetratosylate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 402 ADEMETIONINE TRISULFATE DITOSYLATE DIHYDRATE A, H (S)-S-Adenosylmethionine is a mandatory component of Ademetionine trisulfate ditosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' 403 ADENOPHORA STRICTA A, H 404 ADENOPHORA TRIPHYLLA A, H 405 ADENOSINE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.04%. 406 ADENOSINE PHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 407 ADENOSINE TRIPHOSPHATE E Only for use in topical medicines for dermal application. 408 ADENOSINE TRIPHOSPHATE DISODIUM E Only for use in topical medicines for dermal application. 409 ADIANTUM CAPILLUS-VENERIS A, H 410 ADIPIC ACID E 411 ADIPIC ACID/DIETHYLENE GLYCOL/GLYCERIN CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 412 ADONIS VERNALIS A, H The concentration of equivalent dry Adonis vernalis in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%. 413 ADRENALINE (EPINEPHRINE) H Only for use as an active homoeopathic ingredient. 414 ADZUKI BEAN E 415 AEGOPODIUM PODAGRARIA A, H 416 AESCULUS CHINENSIS A, H 417 AESCULUS GLABRA A, H 418 AESCULUS HIPPOCASTANUM A, H 419 AESCULUS X CARNEA A, H 420 AETHUSA CYNAPIUM H Only for use as an active homoeopathic ingredient. 421 AGAR A, E 422 AGASTACHE RUGOSA A, H 423 AGATHOSMA BETULINA A, E, H Pulegone is a mandatory component of Agathosma betulina. The concentration of pulegone in the medicine must be no more than 4%. 424 AGAVE AMERICANA A, E, H 425 AGRIMONIA EUPATORIA A, E, H 426 AGRIMONIA REPENS A, H 427 AGROSTIS TENUIS A, H 428 AILANTHUS ALTISSIMA A, H 429 AJUGA CHAMAEPITYS A, H 430 AJUGA REPTANS A, H 431 AKKERMANSIA MUCINIPHILA A Only to be used in a medicine where Qintet Pharmaceuticals Pty Ltd, (Client ID 84359) is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 27 September 2026. Only permitted for use in medicines: (a) limited to oral routes of administration; and (b) when the strain of Akkermansia muciniphila is confirmed to be: (i) American Type Culture Collection accession number BAA-835; and/or (ii) Collection de l'Institut Pasteur accession number 107961. The strain of Akkermansia muciniphila must be declared on the label. The maximum recommended daily dose of the medicine must not provide more than 34 billion non-viable cells of pasteurised Akkermansia muciniphila. The ingredient must not contain more than 10 colony forming units per gram viable Akkermansia muciniphila. The following warning statements (or words to the same effect) are required on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women'; and - (ADULT) 'Adults only'. 432 ALANINE A, E 433 ALANYLGLUTAMINE A Only for use in oral medicines. 434 ALARIA ESCULENTA A, H Iodine is a mandatory component of Alaria esculenta. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 435 ALBIZIA JULIBRISSIN A, H 436 ALBIZIA LEBBECK A, H 437 ALCEA ROSEA A, H 438 ALCHEMILLA ALPINA A, H 439 ALCHEMILLA ARVENSIS A, H 440 ALCHEMILLA VULGARIS A, H 441 ALETRIS FARINOSA A, H 442 ALETRIS SPICATA A, H 443 ALEURITES MOLUCCANUS SEED OIL E Only for use in topical medicines for dermal application. 444 ALFADEX A, E Only for use in oral medicines. The maximum daily dose must provide no more than 6 g of alfadex. 445 ALGINATE-KONJAC-XANTHAN POLYSACCHARIDE COMPLEX A Only for use in oral medicines. Only for use when the dosage form is other than tablet. The maximum recommended daily dose must be no more than 13.5 g. When a dose for children is stated, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect). 446 ALGINIC ACID E 447 ALISMA ORIENTALE A, H 448 ALISMA PLANTAGO AQUATICA A, H 449 ALKANNA TINCTORIA A, H 450 ALKYL (C12-15) BENZOATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 21%. 451 ALLANTOIN E Only for use in topical medicines for dermal application. 452 ALLIARIA PETIOLATA A, H 453 ALLIUM CEPA A, H 454 ALLIUM FISTULOSUM A, H 455 ALLIUM HIEROCHUNTINUM A, H 456 ALLIUM MACROSTEMON A, H 457 ALLIUM ODORUM A, H 458 ALLIUM PORRUM A, H 459 ALLIUM SATIVUM A, E, H 460 ALLIUM SCHOENOPRASUM A, H 461 ALLIUM URSINUM A, H 462 ALLO-OCIMENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 463 ALLURA RED AC E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 464 ALLURA RED AC ALUMINIUM LAKE E Permitted for use only as a colour for oral and topical use. 465 ALLYL ALPHA-IONONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 466 ALLYL AMYL GLYCOLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 467 ALLYL CAPRYLATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 468 ALLYL CYCLOHEXANEPROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 469 ALLYL CYCLOHEXYLOXYACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 470 ALLYL HEPTANOATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 471 ALLYL HEPTYLATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 472 ALLYL HEXANOATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 473 ALLYL ISOTHIOCYANATE E Permitted for use only in combination with other permitted ingredients as a flavour. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 474 ALLYL PHENOXYACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 475 ALLYL TIGLATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 476 ALMOND E 477 ALMOND OIL A, E, H Amygdalin and hydrocyanic acid are mandatory components of Almond oil. The concentration of Amygdalin in the medicine must be 0%. The concentration of hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 478 ALNUS GLUTINOSA A, H 479 ALNUS INCANA SUBSP. RUGOSA A, H 480 ALOE FEROX A, E, H When the route of administration is oral or sublingual, Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of Aloe ferox. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect]. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' [or words to that effect]. When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' [or words to that effect]; and - (LAX2) 'Prolonged use may cause serious bowel problems'. 481 ALOE PERRYI A, H When the route of administration is oral or sublingual, Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of Aloe perryi. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect]. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' [or words to that effect]. When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' [or words to that effect]; and - (LAX2) 'Prolonged use may cause serious bowel problems'. 482 ALOE VERA A, E, H When the route of administration is oral or sublingual, Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of Aloe vera. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect]. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' [or words to that effect]. When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' [or words to that effect]; and - (LAX2) 'Prolonged use may cause serious bowel problems'. 483 ALOES CAPE A, H When the route of administration is oral or sublingual, Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of Aloes cape. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect]. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' [or words to that effect]. When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' [or words to that effect]; and - (LAX2) 'Prolonged use may cause serious bowel problems'. 484 ALOYSIA CITRODORA A, H 485 ALPHA CASOZEPINE ENRICHED HYDROLYSED MILK PROTEIN A Only for use in oral medicines. The following warning statement is required on the medicine label: - (BABY3) 'Not suitable for use in children under the age of 12 months except on the advice of a health professional.' (or words to that effect). 486 ALPHA LIPOIC ACID A 487 ALPHA-2,2,6-TETRAMETHYL-CYCLOHEXENEBUTANAL E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 488 ALPHA-AMYL CINNAMALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 489 ALPHA-AMYL CINNAMYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 490 ALPHA-CEDRENE EPOXIDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 491 ALPHA-DAMASCONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 492 ALPHA-FARNESENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 493 ALPHA-FURFURYL OCTANOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 494 ALPHA-HEXYLCINNAMALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 495 ALPHA-IONOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 496 ALPHA-IONONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 497 ALPHA-IRONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 498 ALPHA-ISO-METHYL IONONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 499 ALPHA-METHYL ANISALACETONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 500 ALPHA-METHYL BENZYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 501 ALPHA-METHYL BUTYRALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 502 ALPHA-METHYL BUTYRIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 503 ALPHA-METHYL CINNAMALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 504 ALPHA-METHYL FURFURAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 505 ALPHA-METHYL NAPHTHYL KETONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 506 ALPHA-METHYLCINNAMYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 507 ALPHA-N-METHYL IONONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 508 ALPHA-PHELLANDRENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 509 ALPHA-PINENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 510 ALPHA-SANTALOL E alpha-Santalol must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing alpha-santalol must not be more than 1% of the total medicine. 511 ALPHA-SINENSAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 512 ALPHA-TERPINENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 513 ALPHA-TERPINEOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 514 ALPINIA GALANGA A, H 515 ALPINIA HAINANENSIS A, H 516 ALPINIA OFFICINARUM A, H 517 ALPINIA OXYPHYLLA A, H 518 ALSIDIUM HELMINTHOCHORTON A, H Iodine is a mandatory component of Alsidium helminthochorton. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 519 ALSTONIA BOONEI A, H 520 ALSTONIA CONSTRICTA H Only for use as an active homoeopathic ingredient. 521 ALTERNANTHERA PHILOXEROIDES A, H 522 ALTEROMONAS FERMENT EXTRACT E Only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin or in the eye. The concentration in the medicine must be no more than 0.3%. 523 ALTHAEA OFFICINALIS A, E, H 524 ALUM DODECAHYDRATE A, E, H 525 ALUMINIUM CHLOROHYDRATE E Only for use in topical medicines for dermal application. 526 ALUMINIUM CITRATE E Only for use in topical medicines for dermal application. 527 ALUMINIUM DISTEARATE E Only for use in topical medicines for dermal application. 528 ALUMINIUM HYDROXIDE E Only for use in topical medicines for dermal application. 529 ALUMINIUM HYDROXIDE HYDRATE E Only for use in topical medicines for dermal application. 530 ALUMINIUM MAGNESIUM SILICATE E Magnesium is a mandatory component of aluminium magnesium silicate. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 531 ALUMINIUM MONOSTEARATE E Only for use in topical medicines for dermal application. 532 ALUMINIUM OXIDE E, H When used as an excipient ingredient, only for use in topical medicines for dermal application. When used as an active ingredient, only for use in homoeopathic medicines. 533 ALUMINIUM SILICATE E, H Only for use as an active homoeopathic or excipient ingredient. When used as an excipient ingredient, the medicine is only for use in topical medicines for dermal application. 534 ALUMINIUM SODIUM SILICATE E 535 ALUMINIUM STARCH OCTENYLSUCCINATE E The concentration in the medicine must be no more than 7%. 536 ALUMINIUM STEARATE E Only for use in topical medicines for dermal application. 537 ALUMINIUM SULFATE HYDRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 538 AMARANTH E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 539 AMARANTH ALUMINIUM LAKE E Permitted for use only as a colour for oral and topical use 540 AMARANTHUS HYBRIDUS A, H 541 AMARANTHUS RETROFLEXUS A, H 542 AMBERGRIS EXTRACT E Permitted for use only in combination with other permitted ingredients as a fragrance. The total fragrance concentration in a medicine must be no more than 1%. 543 AMBRETTE SEED OIL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 544 AMBRETTOLIDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 545 AMBRINOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 546 AMBROSIA ARTEMISIIFOLIA A, H 547 AMBROSIA PSILOSTACHYA A, H 548 AMINOCAPROIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. The total concentration of aminocaproic acid in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 549 AMINOPROPYL ASCORBYL PHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 550 AMMI VISNAGA A, H The concentration of equivalent dry Ammi visnaga in the product must be no more than 10mg/Kg or 10mg/L or 0.001%. 551 AMMONIA E, H Only for use as an active homoeopathic or excipient ingredient. When used as an excipient ingredient, the medicine is only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.5%. 552 AMMONIO METHACRYLATE COPOLYMER E Only for use in oral medicines. 553 AMMONIUM ACRYLATES COPOLYMER E Only for use in topical medicines for dermal application. 554 AMMONIUM ACRYLATES/ACRYLONITROGENS COPOLYMER E Only for use in topical medicines for dermal application. 555 AMMONIUM ACRYLOYLDIMETHYLTAURATE/STEARETH-8 METHACRYLATE COPOLYMER E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 556 AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 557 AMMONIUM BICARBONATE A, H When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 558 AMMONIUM BROMIDE H Only for use as an active homoeopathic ingredient. 559 AMMONIUM CARBONATE E, H Only for use as an active homoeopathic or excipient ingredient. 560 AMMONIUM CHLORIDE A, E, H Only for use as an active ingredient in homoeopathic medicines or as an uncompounded medicine substance packed for retail sale. When used as an uncompounded medicine substance the ingredient must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. If used as an excipient ingredient then the medicine is only for topical use for dermal application. 561 AMMONIUM GLYCYRRHIZINATE E 562 AMMONIUM IODIDE H Only for use an active ingredient in homoeopathic medicines. 563 AMMONIUM LACTATE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 564 AMMONIUM LAURETH SULFATE E Only for use in topical medicines for dermal application. 565 AMMONIUM LAURYL SULFATE E Only for use in topical medicines for dermal application. 566 AMMONIUM POLYACRYLATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. 567 AMMONIUM POLYACRYLOYLDIMETHYL TAURATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration must be no more than 3%. 568 AMMONIUM SULFIDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 569 AMOMUM AROMATICUM A, H 570 AMOMUM VILLOSUM A, H 571 AMORPHOPHALLUS KONJAC A, H Only for use when the dosage form is not tablet. 572 AMPELODESMOS MAURITANICUS A, H 573 AMPELOPSIS JAPONICA A, H 574 AMYL ACETATE E Only for use in: - topical medicines for dermal application; or - combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must not be more than 5%. 575 AMYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 576 AMYL BENZOATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 577 AMYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 578 AMYL CAPROATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 579 AMYL CINNAMATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 580 AMYL FORMATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 581 AMYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 582 AMYL ISOVALERATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 583 AMYL OCTANOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 584 AMYL PHENYLACETATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 585 AMYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 586 AMYL SALICYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 587 AMYL VALERATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 588 AMYL VINYL CARBINOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 589 AMYL VINYL CARBINYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 590 AMYLASE A Amylase must be derived from Aspergillus oryzae, and comply with the relevant compositional guideline. 591 AMYLCYCLOHEXYL ACETATE (MIXED ISOMERS) E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 592 AMYLOPECTIN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 593 AMYRIS BALSAMIFERA A, H 594 AMYRIS OIL WEST INDIAN A, E, H 595 ANACARDIUM OCCIDENTALE A, H 596 ANACYCLUS PYRETHRUM A, H 597 ANACYSTIS NIDULANS FERMENT E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.0025%. 598 ANAESTHETIC ETHER H Only for use as an active homoeopathic ingredient. 599 ANAGALLIS ARVENSIS A, H 600 ANAMIRTA COCCULUS A, H Picrotoxin is a mandatory component of Anamirta cocculus. The concentration of picrotoxin in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%. 601 ANANAS COMOSUS A, E, H 602 ANAPHALIS SINICA A, H 603 ANDROGRAPHIS PANICULATA A, H The following warning statement is required on the label: - (ANDROG) 'Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis), stop use and seek immediate medical attention' (or words to that effect). When for oral use, the following warning statement is required on the medicine label: - (ANDROT) 'Andrographis may cause taste disturbance including loss of taste. If you develop any adverse symptoms, stop use and seek medical advice' (or words to that effect). 604 ANEMARRHENA ASPHODELOIDES A, E, H 605 ANEMONE ALTAICA A, H 606 ANEMONE CHINENSIS A, H 607 ANEMONE HEPATICA A, H 608 ANEMONE PULSATILLA A, H 609 ANEMONE RADDEANA A, H 610 ANETHOLE E 611 ANETHOLEA ANISATA E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 612 ANETHUM GRAVEOLENS A, E, H 613 ANGELICA ACUTILOBA A, H 614 ANGELICA ANOMALA A, H 615 ANGELICA ARCHANGELICA A, E, H 616 ANGELICA ATROPURPUREA A, H 617 ANGELICA DAHURICA A, E, H 618 ANGELICA DECURSIVA A, H 619 ANGELICA POLYMORPHA A, E, H 620 ANGELICA PUBESCENS A, E, H 621 ANGELICA ROOT DRY A, H 622 ANGELICA ROOT OIL A, E, H 623 ANGELICA SEED OIL A, E, H 624 ANIBA ROSAEODORA A, E, H 625 ANISALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 626 ANISE ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 627 ANISE OIL A, E, H When the concentration of Anise oil in the preparation is more than 50% the nominal capacity of the container must be no more than 50 mL. When the concentration of Anise oil in the preparation is more than 50% and the nominal capacity of the container is 50 mL or less, a restricted flow insert must be fitted on the container. The medicine requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children (or word to that effect)' 628 ANISEED E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 629 ANISEED DRY A, E, H 630 ANISEED POWDER A, E, H 631 ANISIC ACID E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 632 ANISYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 633 ANISYL ACETONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 634 ANISYL FORMATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 635 ANISYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. 636 ANNATTO E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 637 ANOGEISSUS LATIFOLIA A, E, H 638 ANTENNARIA DIOICA A, E, H 639 ANTHOCYANINS E 640 ANTHOXANTHUM ODORATUM A, H When used as an active ingredient, coumarin is a mandatory component of Anthoxanthum odoratum and the concentration of coumarin in the medicine must be no more than 0.001%. 641 ANTHRISCUS CEREFOLIUM A, H 642 ANTHYLLIS VULNERARIA A, H 643 ANTIMONY POTASSIUM TARTRATE TRIHYDRATE H Only for use as an active homoeopathic ingredient. 644 ANTIMONY TRISULFIDE H Only for use as an active homoeopathic ingredient. 645 APIUM GRAVEOLENS A, E, H 646 APOCYNUM CANNABINUM A, H The concentration of equivalent dry Apocynum cannabinum in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%. 647 APOMORPHINE HYDROCHLORIDE HEMIHYDRATE H Only for use as an active homoeopathic ingredient. 648 APPLE E 649 APPLE CIDER VINEGAR E 650 APPLE ESSENCE NATURAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 651 APPLE EXTRACT E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 652 APPLE FIBRE E 653 APRICOT E 654 APRICOT KERNEL OIL PEG-6 ESTERS E Only for use as an excipient in topical medicines for dermal application. 655 AQUILARIA MALACCENSIS A, H 656 AQUILARIA SINENSIS A, H 657 AQUILEGIA VULGARIS A, H 658 ARACHIDONIC ACID E Only for use in topical medicines for dermal application. 659 ARACHIDYL ALCOHOL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 660 ARACHIDYL GLUCOSIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration must be no more than 0.5%. 661 ARACHIDYL PROPIONATE E Only for use in topical medicines for dermal application. 662 ARACHIS HYPOGAEA A, E, H 663 ARACHIS OIL A, E, H 664 ARALIA CORDATA A, H 665 ARALIA HISPIDA A, H 666 ARALIA NUDICAULIS A, H 667 ARALIA RACEMOSA A, H 668 ARCTIUM LAPPA A, E, H 669 ARCTIUM MINUS A, H 670 ARCTOSTAPHYLOS UVA-URSI A, E, H Beta-arbutin is a mandatory component of Arctostaphylos uva-ursi. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 671 ARDISIA JAPONICA A, H 672 ARGANIA SPINOSA KERNEL OIL E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration must be no more than 5% in the medicine. 673 ARGININE A, E, H Only for use in topical medicines for dermal application. The medicine requires the following warning statement on the medicine label: - (ARGIN1) 'This medicine contains arginine and is intended to be applied to the skin only and not to the mucosa - vagina or rectum.' 674 ARGININE FERULATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.05%. 675 ARISAEMA ATRORUBENS A, H The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material. 676 ARISAEMA CONSANGUINEUM A, H The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material. 677 ARISAEMA JAPONICUM A, H The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material. 678 ARMORACIA RUSTICANA A, E, H Volatile oil components (of Armoracia rusticana) is a mandatory component of Armoracia rusticana. The maximum recommended daily dose must contain no more than 20 mg of volatile oil components (of Armoracia rusticana). 679 ARNEBIA EUCHROMA A, H 680 ARNICA FLOWER DRY A, H When for use other than topically on unbroken skin, the maximum recommended daily dose must be no more than 1mg of the equivalent dry flower of Arnica montana. 681 ARNICA MOLLIS A, H When for use other than topically on unbroken skin, the maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material. 682 ARNICA MONTANA A, H When for use other than topically on unbroken skin, the maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of arnica montana. 683 ARRHENATHERUM ELATIUS A, H 684 ARROWROOT A, E, H 685 ARSENIC TRIIODIDE H Only for use as an active homoeopathic ingredient. The concentration of arsenic in the medicine must be no more than 0.001%. 686 ARSENIC TRIOXIDE H Only for use as an active homoeopathic ingredient. The concentration of arsenic in the medicine must be no more than 0.001%. 687 ARTEMISIA ABROTANUM A, H Thujone is a mandatory component of Artemisia abrotanum. The concentration of thujone from Artemisia abrotanum in the medicine must be no more than 4%. 688 ARTEMISIA ABSINTHIUM A, H Thujone is a mandatory component of Artemisia absinthium. The concentration of thujone from Artemisia absinthium in the medicine must be no more than 4%. The following warning statement is required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant.' 689 ARTEMISIA ANNUA A, H Thujone is a mandatory component of Artemisia annua. The concentration of thujone from Artemisia annua in the medicine must be no more than 4%. The following warning statement is required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant.' 690 ARTEMISIA ARBORESCENS A, H Thujone is a mandatory component of Artemisia arborescens. The concentration of thujone from Artemisia arborescens in the medicine must be no more than 4%. 691 ARTEMISIA ARGYI A, H Thujone is a mandatory component of Artemisia argyi. The concentration of thujone from Artemisia argyi in the medicine must be no more than 4%. 692 ARTEMISIA DRACUNCULUS A, E, H Thujone is a mandatory component of Artemisia dracunculus. The concentration of thujone from Artemisia dracunculus in the medicine must not be more than 4%. The following warning statement is required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); unless the ingredient is: (a) a steam-distilled essential oil; and (b) for use in combination with other permitted ingredients as part of a fragrance or flavour proprietary excipient formulation where: (i) the total concentration of fragrance proprietary excipient formulations containing Artemisia dracunculus is not more than 1% of the total medicine; or (ii) the total concentration of flavour proprietary excipient formulations containing Artemisia dracunculus is not more than 5% of the total medicine. 693 ARTEMISIA FRIGIDA A, H Thujone is a mandatory component of Artemisia frigida. The concentration of thujone from Artemisia frigida in the medicine must not be more than 4%. The following warning statement is required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect). 694 ARTEMISIA HERBA-ALBA A, H Thujone is a mandatory component of Artemisia herba-alba. The concentration of thujone from Artemisia herba-alba in the medicine must be no more than 4%. 695 ARTEMISIA MARITIMA A, H Thujone is a mandatory component of Artemisia maritima. The concentration of thujone from Artemisia maritima in the medicine must be no more than 4%. 696 ARTEMISIA OIL E Thujone is a mandatory component of artemisia oil. Only permitted for use in medicines containing 4% or less of thujone. Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must not be more than 5%. If used in a fragrance the total fragrance concentration in a medicine must not be more than 1%. 697 ARTEMISIA PALLENS A, E, H Thujone is a mandatory component of Artemisia pallens. The concentration of thujone from Artemisia pallens in the medicine must not be more than 4%. The following warning statement is required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); unless the ingredient is: (a) a steam-distilled essential oil; and (b) for use in combination with other permitted ingredients as part of a fragrance or flavour proprietary excipient formulation where: (i) the total concentration of fragrance proprietary excipient formulations containing Artemisia pallens is not more than 1% of the total medicine; or (ii) the total concentration of flavour proprietary excipient formulations containing Artemisia pallens is not more than 5% of the total medicine. 698 ARTEMISIA TRIDENTATA A, H Thujone is a mandatory component of Artemisia tridentata. The concentration of thujone from Artemisia tridentata in the medicine must be no more than 4%. 699 ARTEMISIA VULGARIS A, E, H Thujone is a mandatory component of Artemisia vulgaris. The concentration of thujone from Artemisia vulgaris in the medicine must not be more than 4%. The following warning statement is required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); unless the ingredient is: (a) a steam-distilled essential oil; and (b) for use in combination with other permitted ingredients as part of a fragrance or flavour proprietary excipient formulation where: (i) the total concentration of fragrance proprietary excipient formulations containing Artemisia vulgaris is not more than 1% of the total medicine; or (ii) the total concentration of flavour proprietary excipient formulations containing Artemisia vulgaris is not more than 5% of the total medicine. 700 ARTERY H Only for use as an active homoeopathic ingredient. 701 ARTHROSPIRA MAXIMA A, E, H 702 ARTHROSPIRA PLATENSIS A, E, H 703 ARUM MACULATUM A, H The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material. 704 ASAFOETIDA GUM A, H 705 ASAFOETIDA OIL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 706 ASARUM EUROPAEUM A, H 707 ASARUM HETEROTROPOIDES A, H 708 ASARUM OIL E 709 ASARUM SIEBOLDII A, E, H 710 ASCLEPIAS TUBEROSA A, H 711 ASCOPHYLLUM NODOSUM A, E, H Iodine is a mandatory component of Ascophyllum nodosum. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 712 ASCORBIC ACID A, E 713 ASCORBYL GLUCOSIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 714 ASCORBYL METHYLSILANOL PECTINATE E Only for use in topical medicines for dermal application. 715 ASCORBYL PALMITATE A, E When for oral use, the maximum recommended daily dose must contain no more than 100mg of ascorbyl palmitate. 716 ASCORBYL TOCOPHERYL MALEATE E Only for use as an ingredient in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.0575%. 717 ASPALATHUS LINEARIS A, E, H 718 ASPARAGINE A, E 719 ASPARAGOPSIS SULFATED GALACTANS E Only for use as an ingredient in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.0025%. 720 ASPARAGUS COCHINCHINENSIS A, H 721 ASPARAGUS OFFICINALIS A, E, H 722 ASPARAGUS RACEMOSUS A, H The plant part must be dried, peeled root, and water extracts or ethanol/water extracts (containing up to 45% ethanol) of the dried, peeled root. 723 ASPARTAME E 724 ASPARTIC ACID A, E 725 ASPERGILLUS ORYZAE A, E, H 726 ASTAXANTHIN ESTERS EXTRACTED FROM HAEMATOCOCCUS PLUVIALIS A Only for use in oral medicines. Astaxanthin (of Haematococcus pluvialis) is a mandatory component of astaxanthin esters extracted from Haematococcus pluvialis. The maximum daily dose must contain no more than 12mg of Astaxanthin (of Haematococcus pluvialis). 727 ASTER TATARICUS A, H 728 ASTRAGALUS ADSURGENS A, H 729 ASTRAGALUS COMPLANATUS A, H 730 ASTRAGALUS EXSCAPUS A, H 731 ASTRAGALUS GUMMIFER A, E, H 732 ASTRAGALUS LENTIGINOSUS A, H 733 ASTRAGALUS MEMBRANACEUS A, E, H 734 ASTRAGALUS PENDULIFLORUS A, H 735 ASTROCARYUM MURUMURU SEED TRIGLYCERIDES E Only for use as an ingredient in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.21%. 736 ATRACTYLODES JAPONICA A, H 737 ATRACTYLODES LANCEA A, H 738 ATRACTYLODES MACROCEPHALA A, H 739 ATROPA BELLADONNA A, H Alkaloids calculated as hyoscyamine and atropine are mandatory components of Atropa belladonna. The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. The concentration of atropine in the medicine must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%. 740 ATROPINE SULFATE MONOHYDRATE H Only for use as an active homoeopathic ingredient. The concentration of atropine in the medicine must not be more than 300 micrograms/kg or 300 micrograms/L or 0.00003%. 741 ATTALEA SPECIOSA E Only for use in topical medicines for dermal application. 742 AURA B-AURANTIOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 743 AUREOBASIDIUM PULLULANS A, H 744 AVENA FATUA A, H Gluten is a mandatory component of Avena fatua when the plant part is seed and the route of administration is other than topical and mucosal. 745 AVENA SATIVA A, E, H Gluten is a mandatory component of Avena sativa when the plant part is seed and the route of administration is other than topical and mucosal. 746 AVOCADO OIL E 747 AVOCADO OIL UNSAPONIFIABLES E Only for use in topical medicines for dermal application. 748 AZADIRACHTA INDICA A, H The ingredient can only be derived from the plant part seed and must be cold pressed or debitterised oil. "Debitterised neem seed oil" means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids. Cold pressed Azadirachta indica seed oil must be for topical use for dermal application only. When the concentration of cold pressed Azadirachta indica seed oil is more than 1%, a child resistant closure must be fitted to the container. The medicine requires the following warning statements on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant (or words to that effect).' - (NTAKEN) 'Not to be taken (or words to that effect).' - (CHILD) 'Keep out of reach of children (or words to that effect).' 749 AZOVAN BLUE E Permitted for use only as a colour for topical use. 750 AZULENE E Only for use in topical medicines for dermal application. Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine Note: See sections 5 and 6. Permissible ingredients and requirements Column 1 Column 2 Column 3 Column 4 Item Ingredient name Purpose Specific requirements 751 BACILLUS COAGULANS A Only permitted for use in medicines: (a) limited to oral routes of administration; and (b) when the strain of Bacillus coagulans is confirmed to be: (i) Microbial Type Culture Collection (MTCC) accession number 5260; and/or (ii) MTCC accession number 5856. The strain of Bacillus coagulans must be declared on the label. When the strain of Bacillus coagulans is MTCC accession number 5260: (a) the maximum recommended daily dose of the medicine must not provide more than 6 billion cfu of Bacillus coagulans strain MTCC accession number 5260; and (b) the following warning statements are required on the medicine label: - (CHILD2) 'Not suitable for children'; and - (BACCOAG) 'Bacillus coagulans may affect the way some medicines work, including immunosuppressants. Consult your health professional before taking with other medicines (or words to that effect).' When the strain of Bacillus coagulans is MTCC accession number 5856: (a) the maximum recommended daily dose of the medicine must not provide more than 2 billion cfu of Bacillus coagulans strain MTCC accession number 5856; and (b) the following warning statements are required on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect); - (CHILD2) 'Not suitable for children'; and - (BACCOAG) 'Bacillus coagulans may affect the way some medicines work, including immunosuppressants. Consult your health professional before taking with other medicines (or words to that effect).' 752 BACILLUS SUBTILIS A Only to be used in a medicine where ADM Australia Pty Ltd (Client ID 33326), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 14 June 2026. The route of administration for medicines that contain Bacillus subtilis must be limited to oral. Only permitted for use in medicines when the strain of Bacillus subtilis is confirmed to be Agricultural Research Service Culture Collection (NRRL) accession number B-67989. The strain of Bacillus subtilis must be declared on the label. Bacillus subtilis is not permitted for use in children under the age of 2 years. The maximum recommended daily dose of the medicine must not provide more than: (a) 1 billion cfu Bacillus subtilis in individuals aged 2 to 17 years (inclusive); and (b) 5 billion cfu Bacillus subtilis in individuals aged 18 years and above. The following warning statements (or words to the same effect) are required on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women'; - (ANTIBI1) 'To be administered 2-3 hours before or after antibiotics'; and - (IMMUNO2) 'May not be suitable for someone taking immunomodulators. Consult your health professional before taking with other medicines'. 753 BACKHOUSIA CITRIODORA A, E, H The herbal substance must be derived from leaf oil only. Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 10g/kg or 10g/L or 1%. The medicine requires the following warning statements on the medicine label: - (IRRIT) 'If irritation develops - discontinue use' - (CHILD3) 'Use in children under 12 years is not recommended' - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect). 754 BACOPA MONNIERI A, H 755 BALLOTA NIGRA A, H 756 BALM OF GILEAD BUD DRY A, H 757 BALM OF GILEAD BUD POWDER A, H 758 BALSAM COPAIBA E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 759 BAMBUSA BREVIFLORA A, E, H 760 BAMBUSA TEXTILIS A, H 761 BANANA E 762 BANANA DISTILLATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 763 BAPTISIA CONFUSA A, H 764 BAPTISIA TINCTORIA A, H 765 BARBAREA VULGARIS A, H 766 BARIUM CARBONATE H Only for use as an active homoeopathic ingredient. 767 BARIUM CHLORIDE H Only for use as an active homoeopathic ingredient. 768 BARIUM SULFATE E Only for use in topical medicines for dermal application. 769 BARLEY E Gluten is a mandatory component of Barley when the route of administration is other than topical and mucosal. 770 BARLEY LEAF E 771 BASIC BUTYLATED METHACRYLATE COPOLYMER E Only for use in oral medicines. 772 BASIC FUCHSIN E Only for use as a colour ingredient in topical medicines for dermal application. 773 BASIC RED 1 E Only for use as a colour in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.1%. 774 BASIC VIOLET 11:1 E Only for use as a colour in topical medicines for dermal application and not intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.1%. 775 BASIL OIL COMOROS A, E, H Methyl chavicol is a mandatory component of Basil oil Comoros. When the concentration of Methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL. When the concentration of Methyl chavicol in the medicine is more than 5% and the nominal capacity of the container is 25mL or less, a restricted flow insert must fitted on the container, and the medicine requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). 776 BASIL OIL EUROPEAN A, E, H Methyl chavicol is a mandatory component of Basil oil European. When the concentration of Methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL. When the concentration of Methyl chavicol in the medicine is more than 5% and the nominal capacity of the container is 25mL or less, a restricted flow insert must fitted on the container, and the medicine requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). 777 BASSIA SCOPARIA A, H 778 BATYL ALCOHOL E Only for use in topical medicines for dermal application. 779 BAY LEAF E 780 BAY OIL A, E, H When the total concentration of bay oil in the medicine is more than 25%: (a) the nominal capacity of the container must not be more than 25 mL; (b) the container must be fitted with a restricted flow insert; (c) the following warning statements are required on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect); - (NTAKEN) 'Not to be taken'; and (d) when the nominal capacity of the container is greater than 15 mL, the container must also be fitted with a child resistant closure. 781 BEESWAX ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 782 BEESWAX ALCOHOLS A The route of administration for medicines that contain beeswax alcohols must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 150 mg beeswax alcohols. The following warning statements (or words to the same effect) are required on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women'; and - (CHILD2) 'Not suitable for children'. 783 BEET RED E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 784 BEETROOT E, H 785 BEGONIA FIMBRISTIPULA A, H 786 BEHENETH-10 E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%. Residual levels of ethylene oxide are to be kept below the level of detection. 787 BEHENIC ACID E When for oral ingestion, the maximum recommended daily dose must not provide more than 383.5 milligrams of behenic acid. 788 BEHENOXY DIMETHICONE E Only for use in topical medicines for dermal application. 789 BEHENOYL STEARIC ACID E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 2.4%. 790 BEHENTRIMONIUM METILSULFATE E Behentrimonium metilsulfate must: (a) Only be used in topical medicines for dermal application; and (b) Not be included in medicines intended for use on broken skin or in the eye. The concentration in the medicine must not be more than 1.06%. 791 BEHENYL ALCOHOL E Only for use in topical medicines for dermal application. 792 BELLADONNA HERB DRY A, H Alkaloids calculated as hyoscyamine and atropine are mandatory components of Belladonna herb dry. The concentration of alkaloids calculated as hyoscyamine in the medicine and must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. The concentration of atropine in the medicine must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%. 793 BELLADONNA HERB POWDER A, H Alkaloids calculated as hyoscyamine and atropine are mandatory components of Belladonna herb powder. The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. The concentration of atropinei n the medicine must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%. 794 BELLADONNA HERB PREPARED A, H Alkaloids calculated as hyoscyamine and atropine are mandatory components of Belladonna herb prepared and must be declared in the application. The concentration of alkaloids calculated as hyoscyamine from all ingredients in the product must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. The concentration of atropine from all ingredients in the product must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%. 795 BELLIS PERENNIS A, H 796 BEMOTRIZINOL A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 797 BENINCASA HISPIDA A, E, H 798 BENTONITE E 799 BENZALDEHYDE E 800 BENZALDEHYDE GLYCERYL ACETAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 801 BENZALKONIUM CHLORIDE E Only for use in topical medicines for dermal application and nasal sprays. When benzalkonium chloride is used in a topical medicine for dermal application, the concentration in the medicine must not be more than 5%. When benzalkonium chloride is used in a nasal spray dosage form, the concentration of benzalkonium chloride in the medicine must not be more than 0.03%. When benzalkonium chloride is used in a nasal spray dosage form which is either: (i) indicated for use in children; or (ii) not specifically indicated for adults only; the following warning statement is required on the medicine label: - (NTAKEN2) 'Not to be used by children under 2 years old' (or words to that effect). 802 BENZETHONIUM CHLORIDE E Only for use as a preservative in topical medicines for dermal application. 803 BENZOIC ACID E, H 804 BENZOIN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 805 BENZOIN SIAM A, E, H 806 BENZOIN SUMATRA A, E, H 807 BENZOPHENONE E Permitted for topical use only in combination with other permitted ingredients as a fragrance. The total concentration of fragrance proprietary excipient formulations containing benzophenone must not be more than 1% of the total medicine. 808 BENZOTHIAZOLE E Benzothiazole must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing benzothiazole must not be more than 1% of the total medicine. 809 BENZYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 810 BENZYL ACETONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used as a fragrance the total fragrance concentration in a medicine must be no more than 1%. 811 BENZYL ALCOHOL A, E When used as an active ingredient: a) permitted for use only in medicated throat lozenges; and b) when the maximum recommended daily dose of the medicine provides more than 300mg, the following warning statement must be included on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect). 812 BENZYL BENZOATE E Only for use in topical medicines for dermal application. 813 BENZYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 814 BENZYL CINNAMATE E Only for use in: (a) topical medicines for dermal application when the concentration of benzyl cinnamate in the medicine is not greater than 0.15%; or (b) medicines in combination with other permitted ingredients as a constituent of a flavour proprietary excipient formulation when the total flavour proprietary excipient formulation in the medicine is not more than 5%. Not to be included in medicines intended for use in the eye. 815 BENZYL DIMETHYL CARBINYL-N-BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 816 BENZYL FORMATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 817 BENZYL ISOAMYL ETHER E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 818 BENZYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 819 BENZYL ISOVALERATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 820 BENZYL LAURATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 821 BENZYL PHENYLACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 822 BENZYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 823 BENZYL SALICYLATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 824 BENZYL TIGLATE E Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. 825 BENZYLIDENE ACETONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 826 BENZYLIDENE CAMPHOR SULFONIC ACID A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 6% (as acid). When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 827 BERBERIS AQUIFOLIUM A, H 828 BERBERIS ARISTATA A Only for use in oral medicines. The medicine requires the following warning statement on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect). 829 BERBERIS VULGARIS A, E, H 830 BERGAMOT OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour, the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance, the total fragrance concentration in a medicine must be no more 1%. The medicine requires the following warning statement on the medicine label: - (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect) 831 BERGAMOT OIL BERGAPTEN-FREE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 832 BERGAMOT OIL COLDPRESSED A, E, H When for internal use oxedrine is a mandatory component of bergamot oil coldpressed. The maximum recommended daily dose must provide no more than 30 milligrams of oxedrine. The warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) in preparations containing 0.4 per cent or less of bergamot oil coldpressed; or c) for use in soaps or bath or shower gels that are washed off the skin. 833 BERGAMOT OIL TERPENELESS E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 834 BERTHOLLETIA EXCELSA A, E, H 835 BETA RAPA A, E, H 836 BETA VULGARIS A, E, H 837 BETA,4-DIMETHYLCYCLOHEX-3-ENE-1-PROPAN-1-AL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 838 BETA-CARYOPHYLLENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 839 BETA-CARYOPHYLLENE ALCOHOL E Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. 840 BETA-DAMASCENONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 841 BETA-DAMASCONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 842 BETA-HOMO CYCLOCITRAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 843 BETA-HYDROXY-BETA-METHYLBUTYRIC ACID A 844 BETA-IONONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 845 BETA-IONONE EPOXIDE E Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. 846 BETA-ISO-METHYL IONONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 847 BETA-METHYL NAPHTHYL KETONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 848 BETA-N-METHYL IONONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 849 BETA-NAPHTHOL ETHYLETHER E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 850 BETA-NAPHTHOL METHYL ETHER E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 851 BETA-NAPHTHYL ANTHRANILATE E Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. 852 BETA-NAPHTHYL ISOBUTYL ETHER E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 853 BETA-PINENE E Permitted for use only in combination with other permitted ingredients as a flavour or fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 854 BETA-TOCOPHEROL E 855 BETACAROTENE A, E When Vitamin A is declared as an equivalent of Betacarotene and the medicine is for oral or sublingual use in adults the medicine requires the following warning statement on the medicine label: - (VITA3) 'The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.' 856 BETADEX E 857 BETAGLUCAN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.01%. 858 BETAINE E Only for use in topical medicines for dermal application. 859 BETAINE HYDROCHLORIDE E 860 BETULA LENTA A, H Methyl salicylate is a mandatory component of Betula lenta. Not to be included in medicines for use in the eye or on damaged skin. When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is spray, the medicine does not require child resistant packaging if: - the delivery device is engaged into the container in such a way that prevents it from being readily removed; - direct suction through the delivery device results in delivery of no more than one dosage unit; and - actuation of the spray device is ergonomically difficult for young children to accomplish. The following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect). When for use in topical medicines for dermal application: i) the concentration of methyl salicylate in the medicine must not be more than 25%; ii) the following warning statements are required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less'; - (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect); - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect); iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label: - (IRRIT) 'If irritation develops, discontinue use'. 861 BETULA NIGRA A, H Cresol, eugenol and methyl salicylate are mandatory components of Betula nigra. For external use only when the total concentration of cresols, xylenols and other phenol homologues in the medicine is greater than 3%. When for internal use, the concentration of eugenol in the medicine must not exceed 0.06%. When the concentration of eugenol in the medicine is more than 25%: a) the nominal capacity of the container must be no more than 25 mL; b) the medicine must be fitted with a restricted flow insert; c) when the nominal capacity of the container is more than 15 mL, the medicine must be fitted with a child resistant closure; and d) the medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. Not to be included in medicines for use in the eye or on damaged skin. When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is spray, the medicine does not require child resistant packaging if: - the delivery device is engaged into the container in such a way that prevents it from being readily removed; - direct suction through the delivery device results in delivery of no more than one dosage unit; and - actuation of the spray device is ergonomically difficult for young children to accomplish. The following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect). When for use in topical medicines for dermal application: i) the concentration of methyl salicylate in the medicine must not be more than 25%; ii) the following warning statements are required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less'; - (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect); - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect); iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label: - (IRRIT) 'If irritation develops, discontinue use'. 862 BETULA PENDULA A, E, H Methyl salicylate is a mandatory component of Betula pendula. Not to be included in medicines for use in the eye or on damaged skin. When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is spray, the medicine does not require child resistant packaging if: - the delivery device is engaged into the container in such a way that prevents it from being readily removed; - direct suction through the delivery device results in delivery of no more than one dosage unit; and - actuation of the spray device is ergonomically difficult for young children to accomplish. The following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect). When for use in topical medicines for dermal application: i) the concentration of methyl salicylate in the medicine must not be more than 25% ii) the following warning statements are required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less'; - (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect); - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect); iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label: - (IRRIT) 'If irritation develops, discontinue use'. 863 BETULA PUBESCENS A, E, H 864 BICYCLO(2.2.1)HEPT-5-ENE-2-CARBOXYLIC ACID, 3-(1-METHYLETHYL)-, ETHYL ESTER, (1R,2R,3R,4S)-REL- E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 865 BICYCLO(2.2.2)OCT-5-ENE-2-CARBOXALDEHYDE, 6-METHYL-8-(1-METHYLETHYL)- E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 866 BIFIDOBACTERIUM ADOLESCENTIS A 867 BIFIDOBACTERIUM ANIMALIS A 868 BIFIDOBACTERIUM ANIMALIS SSP ANIMALIS A 869 BIFIDOBACTERIUM ANIMALIS SSP LACTIS A 870 BIFIDOBACTERIUM BIFIDUM A 871 BIFIDOBACTERIUM BREVE A 872 BIFIDOBACTERIUM INFANTIS A 873 BIFIDOBACTERIUM LACTIS A 874 BIFIDOBACTERIUM LONGUM A 875 BILBERRY E 876 BIOSACCHARIDE GUM-1 E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 877 BIOTA ORIENTALIS A, H 878 BIOTIN A, E 879 BIRCH LEAF DRY A, E, H Methyl salicylate is a mandatory component of birch leaf dry. Not to be included in medicines for use in the eye or on damaged skin. When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is spray, the medicine does not require child resistant packaging if: - the delivery device is engaged into the container in such a way that prevents it from being readily removed; - direct suction through the delivery device results in delivery of no more than one dosage unit; and - actuation of the spray device is ergonomically difficult for young children to accomplish. The following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect). When for use in topical medicines for dermal application: i) the concentration of methyl salicylate in the medicine must not be more than 25% ii) the following warning statements are required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less'; - (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect); - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect); iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label: - (IRRIT) 'If irritation develops, discontinue use'. 880 BIRCH TAR OIL RECTIFIED A, E, H Cresol is a mandatory component of birch tar oil rectified. For external use only when the total concentration of cresols, xylenols and other phenol homologues in the medicine is greater than 3%. 881 BIS-BUTYLDIMETICONE POLYGLYCERYL-3 E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 1.5%. 882 BIS-DIGLYCERYL POLYACYLADIPATE-2 E Only for use in topical medicines for dermal application. 883 BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. 884 BIS-MACROGOL 900 METHYL ETHER DIMETHYL SILANE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2.5%. 885 BIS-PEG-12 DIMETHICONE BEESWAX E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. 886 BIS-STEARYL DIMETICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 2.30%. 887 BIS-STEARYL ETHYLENEDIAMINE/NEOPENTYL GLYCOL/STEARYL HYDROGENATED DIMER DILINOLEATE COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 7%. 888 BISABOLENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 889 BISABOLOL E If used as an excipient, the medicine is only for use in topical medicines for dermal application. 890 BITTER ALMOND OIL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. The absence of amygdalin in the medicine must be declared. 891 BITTERN A, E, H Magnesium is a mandatory component of bittern. Only permitted for use in: (a) medicines limited to oral routes of administration; and (b) topical medicines for dermal administration. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 892 BIXA ORELLANA A, E, H 893 BLACK BONED CHICKEN POWDER A 894 BLACK COHOSH DRY A, H The medicine requires the following warning statement on the medicine label: - (BCOHOSH) 'Warning: In very rare cases - black cohosh has been associated with liver failure. If you are experiencing yellowing of the skin or whites of the eyes - dark urine - nausea - vomiting - unusual tiredness - weakness - stomach or abdominal pain - and/or loss of appetite - you should stop using this product and see your doctor.' 895 BLACK COHOSH POWDER A, H The medicine requires the following warning statement on the medicine label: - (BCOHOSH) 'Warning: In very rare cases - black cohosh has been associated with liver failure. If you are experiencing yellowing of the skin or whites of the eyes - dark urine - nausea - vomiting - unusual tiredness - weakness - stomach or abdominal pain - and/or loss of appetite - you should stop using this product and see your doctor.' 896 BLACK CURRANT E 897 BLACK CURRANT ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 898 BLACK CURRANT FRESH A, E, H 899 BLACK CURRANT SEED OIL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 900 BLACK OF CURACAO SPIDER H Only for use as an active homoeopathic ingredient. 901 BLACK PEPPER OIL A, E, H 902 BLACK RASPBERRY E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 903 BLACK SNAKE H Only for use as an active homoeopathic ingredient. 904 BLACKBERRY E 905 BLACKBERRY OILS E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 906 BLACKBERRY WINE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 907 BLACKCURRANT ESTERS E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 908 BLACKCURRANT JUICE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 909 BLACKSTRAP MOLASSES E When for oral or sublingual use, sucrose is a mandatory component of blackstrap molasses. 910 BLADDERWRACK DRY A, H Iodine is a mandatory component of Bladderwrack dry. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 911 BLADDERWRACK POWDER A, H Iodine is a mandatory component of Bladderwrack powder. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 912 BLAINVILLEA ACMELLA A, E, H When used as an excipient, permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 913 BLETILLA STRIATA A, H 914 BLUE FLAG RHIZOME DRY A, H 915 BLUE FLAG RHIZOME POWDER A, H 916 BLUEBERRY E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 917 BLUEBERRY JUICE E Permitted for use only in combination with other permitted ingredients as a flavour or fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 918 BLUMEA LACERA A, H 919 BOEHMERIA NIVEA A, H 920 BOERHAVIA DIFFUSA A, H 921 BOERHAVIA REPENS A, H 922 BOGBEAN LEAF DRY A, H 923 BOGBEAN LEAF POWDER A, H 924 BOIS DE ROSE OIL A, E, H 925 BOMBAX CEIBA A, H 926 BORAGO OFFICINALIS A, E, H Only for use when the preparation is 'fixed oil' and the fixed oil is derived from seeds of Borago officinalis. 927 BORAX A, E, H Boron is a mandatory component of borax. The percentage of boron from borax should be calculated based on the molecular weight of borax. The maximum recommended daily dose must not provide more than 6mg of boron. In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%. When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label: - (NTAKEN12) 'Not to be taken by children under 12 years old' (or words to that effect); or - (ADULT) 'Adults only' (or words to that effect). When the maximum recommended daily dose of the medicine provides more than 1 mg boron and up to, and including, 3 mg of boron, and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label: - (NTAKEN2) 'Not to be taken by children under 2 years old' (or words to that effect); or - (ADULT) 'Adults only' (or words to that effect). When for excipient use and the maximum recommended daily dose of the medicine provides more than 1 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label: - (BORON) 'Contains boron' (or words to that effect). When the medicine is for topical use for dermal application, the following warning statement is required on the label: - (BROKEN) 'Use on unbroken skin only' (or words to that effect). 928 BORAX PENTAHYDRATE A, E Boron is a mandatory component of borax pentahydrate. The percentage of boron from borax pentahydrate should be calculated based on the molecular weight of borax pentahydrate. The maximum recommended daily dose must not provide more than 6mg of boron from borax pentahydrate. In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must not be more than 3500 mg/kg or 3500 g/L or 0.35%. When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label: - (NTAKEN12) 'Not to be taken by children under 12 years old' (or words to that effect); or - (ADULT) 'Adults only' (or words to that effect). When the maximum recommended daily dose of the medicine provides more than 1 mg boron and up to, and including, 3 mg of boron, and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label: - (NTAKEN2) 'Not to be taken by children under 2 years old' (or words to that effect); or - (ADULT) 'Adults only' (or words to that effect). When for excipient use and the maximum recommended daily dose of the medicine provides more than 1 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label: - (BORON) 'Contains boron' (or words to that effect). When the medicine is for topical use for dermal application, the following warning statement is required on the label: - (BROKEN) 'Use on unbroken skin only' (or words to that effect). 929 BORIC ACID A, H Boron is a mandatory component of boric acid. The percentage of boron from boric acid should be calculated based on the molecular weight of boric acid. The maximum recommended daily dose must not provide more than 6mg of boron. In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must not be more than 3500 mg/kg or 3500 mg/L or 0.35%. When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label: - (NTAKEN12) 'Not to be taken by children under 12 years old' (or words to that effect); or - (ADULT) 'Adults only' (or words to that effect). When the maximum recommended daily dose of the medicine provides more than 1 mg boron and up to, and including, 3 mg of boron, and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label: - (NTAKEN2) 'Not to be taken by children under 2 years old' (or words to that effect); or - (ADULT) 'Adults only' (or words to that effect). When for excipient use and the maximum recommended daily dose of the medicine provides more than 1 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label: - (BORON) 'Contains boron' (or words to that effect). When the medicine is for topical use for dermal application, the following warning statement is required on the label: - (BROKEN) 'Use on unbroken skin only' (or words to that effect). 930 BORNEOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 931 BORNYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 932 BORON NITRIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 933 BORONIA ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 934 BORONIA MEGASTIGMA E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 935 BOSWELLIA CARTERII A, E, H 936 BOSWELLIA SERRATA A, E, H 937 BOSWELLIA THURIFERA A, H 938 BOVINE CALCIUM CHONDROITIN SULFATE A 939 BOVINE CHONDROITIN SULFATE A 940 BOVINE COLOSTRUM POWDER A The following warning statement is required on the medicine label: - (BABY3) 'Not suitable for use in children under the age of 12 months except on the advice of a health professional.' (or words to that effect). 941 BOVINE LACTOFERRIN A 942 BOVINE POTASSIUM CHONDROITIN SULFATE A 943 BOVINE SODIUM CHONDROITIN SULFATE A, E When used as an excipient: - only for use in topical medicines for dermal application; - not to be included in medicines intended for use in the eye; and - the concentration in the medicine must be no more than 0.001%. 944 BOVINE WHEY IG-RICH FRACTION A Only for use in oral medicines. The following warning statement is required on the medicine label: - (BABY3) 'Not suitable for use in children under the age of 12 months except on the advice of a health professional.' (or words to that effect). 945 BRANDY E 946 BRASSICA CAMPESTRIS/ALEURITES FORDI OIL COPOLYMER E Only for use in topical medicines for dermal application and not for use in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 947 BRASSICA CHINENSIS A, H Allyl isothiocyanate is a mandatory component of Brassica chinensis when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 948 BRASSICA JUNCEA A, H Allyl isothiocyanate is a mandatory component of Brassica juncea when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 949 BRASSICA NAPUS A, E, H Allyl isothiocyanate is a mandatory component of Brassica napus when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 950 BRASSICA NIGRA A, H Allyl isothiocyanate is a mandatory component of Brassica nigra when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 951 BRASSICA OLERACEA VAR. BOTRYTIS A, E, H Allyl isothiocyanate is a mandatory component of Brassica oleracea var. botrytis when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 952 BRASSICA OLERACEA VAR. CAPITATA A, E, H Allyl isothiocyanate is a mandatory component of Brassica oleracea var. capitata when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 953 BRASSICA OLERACEA VAR. GEMMIFERA A, H Allyl isothiocyanate is a mandatory component of Brassica oleracea var gemmifera when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 954 BRASSICA OLERACEA VAR. ITALICA A, H Allyl isothiocyanate is a mandatory component of Brassica oleracea var. italica when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 955 BRASSICA OLERACEA VAR. VIRIDIS A, H Allyl isothiocyanate is a mandatory component of Brassica oleracea var. viridis when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 956 BRASSICA PEKINENSIS A, H Allyl isothiocyanate is a mandatory component of Brassica pekinensis when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 957 BRASSICA RAPA A, E, H Allyl isothiocyanate is a mandatory component of Brassica rapa when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 958 BRILLIANT BLACK BN E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 959 BRILLIANT BLUE FCF E Permitted for use only as a colour for oral, topical and dental use. 960 BRILLIANT BLUE FCF ALUMINIUM LAKE E Permitted for use only as a colour for oral and topical use. 961 BRILLIANT BLUE FCF BARIUM LAKE E Permitted for use only as a colour for oral and topical use. 962 BRILLIANT SCARLET 4R E Permitted for use only as a colour in medicines for topical and oral routes of administration. 963 BRILLIANT SCARLET 4R ALUMINIUM LAKE E Permitted for use only as a colour in medicines for topical and oral routes of administration. 964 BRIZA MEDIA A, H 965 BROCCOLI E 966 BROMELAINS A May be derived from either the stem or fruit of the pineapple (Ananas comosus). 967 BROMOSTYROL E Not for use in infants Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 968 BROMUS CATHARTICUS A, H 969 BROMUS INERMIS A, H 970 BROMUS RAMOSUS SUBSP. RAMOSUS A, H 971 BRONOPOL E Only for use in topical medicines for dermal application. 972 BROUSSONETIA PAPYRIFERA A, H 973 BROWN FK E Permitted for use only as a colour for topical use. 974 BRUNFELSIA UNIFLORA A, H The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material. 975 BRUSSEL SPROUT E 976 BRYONIA ALBA A, H 977 BRYONIA DIOICA A, H 978 BUCHU LEAF DRY A, H 979 BUCHU LEAF OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 980 BUCHU LEAF POWDER A, E, H 981 BUCKWHEAT E, H Only for use as an active homoeopathic or excipient ingredient. 982 BUDDLEJA OFFICINALIS A, H 983 BULNESIA SARMIENTI A, E, H 984 BUNIAS ORIENTALIS A, H 985 BUPLEURUM FALCATUM A, H 986 BURDOCK LEAF DRY A, H 987 BURDOCK LEAF POWDER A, H 988 BURDOCK ROOT DRY A, H 989 BURDOCK ROOT POWDER A, H 990 BUSHMASTER SNAKE H Only for use as an active homoeopathic ingredient. 991 BUTAN-1-OL E The residual solvent limit for Butan-1-ol is 50 mg per maximum recommended daily dose. The concentration in the medicine must be no more than 0.5%. 992 BUTANE E Only for use as an excipient propellant ingredient. 993 BUTOXYETHANOL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 994 BUTTER E 995 BUTTER ACIDS E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 996 BUTTER ESTERS E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 997 BUTTER STARTER DISTILLATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 998 BUTYL 2-METHYLBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 999 BUTYL ACETATE E The residual solvent limit for Butyl acetate is 50 mg per maximum recommended daily dose. The concentration in the medicine must be no more than 0.5%. 1000 BUTYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1001 BUTYL BUTYRYL LACTATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1002 BUTYL CAPROATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1003 BUTYL ESTER OF PVM/MA COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 15%. The medicine requires the following warning statements on the medicine label: - (EYE) 'Avoid contact with eyes' (or words to that effect) - (EYE2) 'May be irritant to the eyes' (or words to that effect). 1004 BUTYL FORMATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1005 BUTYL HYDROXYBENZOATE E Only for use in topical medicines for dermal application. 1006 BUTYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1007 BUTYL ISOVALERATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1008 BUTYL LACTATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1009 BUTYL LEVULINATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1010 BUTYL METHOXYDIBENZOYLMETHANE A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in preparation must not be more than 5%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 1011 BUTYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1012 BUTYL STEARATE E Only for use in topical medicines for dermal application. 1013 BUTYL UNDECYLENATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1014 BUTYLATED HYDROXYANISOLE E 1015 BUTYLATED HYDROXYTOLUENE E 1016 BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. 1017 BUTYLIDENE PHTHALIDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1018 BUTYLOCTYL SALICYLATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 7%. 1019 BUTYLPHENYL METHYLPROPIONAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1020 BUTYRALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1021 BUTYRIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1022 C1-8 ALKYL TETRAHYDROXYCYCLOHEXANOATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.012%. 1023 C10-12 ALKANE/CYCLOALKANE E Only permitted for use in solid or semi-solid medicines or in medicines: (a) containing 25% or less of hydrocarbons, liquid; or (b) when packed in pressurised spray packs; or (c) when packed in containers with a capacity of 2 millilitres or less. Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must not be more than 1%. 1024 C10-30 CHOLESTEROL/LANOSTEROL ESTERS E Only for use in topical medicines for dermal application. 1025 C11-13 ALKANE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. 1026 C11-14-ISO-ALCOHOL C-13 RICH E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1027 C12-13 PARETH-23 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.125%. Residual levels of 1,4-dioxane and ethylene oxide (and related substances) are to be kept below the level of detection. 1028 C12-13 PARETH-3 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.125%. Residual levels of 1,4-dioxane and ethylene oxide (and related substances) are to be kept below the level of detection. 1029 C12-15 ALKYL LACTATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.2%. 1030 C12-15 ALKYL OCTANOATE E Only for use in topical medicines for dermal application. 1031 C12-20 ACID PEG-8 ESTER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. 1032 C12-20 ALKYL GLUCOSIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.75%. 1033 C12-22 ALKYL ACRYLATE/HYDROXYETHYLACRYLATE COPOLYMER E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration of C12-22 alkyl acrylate/hydroxyethylacrylate copolymer in the medicine must not be more than 5%. 1034 C13-14 ISOPARAFFIN E Only for use in topical medicines for dermal application. 1035 C14-22 ALCOHOLS E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2.55%. 1036 C15-16 ISOPARAFFIN E C15-16 isoparaffin must only be included in topical medicines: (a) for dermal application; and (b) where the dosage form of the medicine is not spray. The total concentration of C15-16 isoparaffin and C17-18 isoparaffin in the medicine must not be more than 50%. When the nominal capacity of the container is more than 2 mL and the medicine is not a solid or semi-solid preparation, the total concentration of designated solvents (including C15-16 isoparaffin) in the medicine must not be more than 25%. 1037 C15-19 ALKANE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 7%. 1038 C17-18 ISOPARAFFIN E C17-18 isoparaffin must only be included in topical medicines: (a) for dermal application; and (b) where the dosage form of the medicine is not spray. The total concentration of C15-16 isoparaffin and C17-18 isoparaffin in the medicine must not be more than 50%. When the nominal capacity of the container is more than 2 mL and the medicine is not a solid or semi-solid preparation, the total concentration of designated solvents (including C17-18 isoparaffin) in the medicine must not be more than 25%. 1039 C18-36 ACID GLYCOL ESTER E Only for use topical medicines for dermal application. 1040 C18-36 ACID TRIGLYCERIDE E Only for use in topical medicines for dermal application. 1041 C2-OCTENAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1042 C20-40 ALCOHOLS E Only for use in topical medicines for dermal application. 1043 C20-40 ALKYL STEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 1044 C20-40 PARETH-24 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.25%. 1045 C20-40 PARETH-3 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 1046 C30-45 ALKYL CETEARYL DIMETICONE CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 1047 C9-11 ISOPARAFFIN E Only for use in topical medicines for dermal application. 1048 C9-11 PARETH-3 E Only for use in topical medicines for dermal application. 1049 C9-15 ALKYL PHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.12% 1050 CABBAGE E 1051 CABREUVA OIL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1052 CADE OIL A, E, H 1053 CAESALPINIA SAPPAN A, H 1054 CAFFEINE A, E, H When used as an excipient, only for use in topical medicines for dermal application. Only for use as an active ingredient for: (a) oral use in adults when the medicine consists principally of one or more designated active ingredients prescribed in Schedule 14 to the Regulations (other than caffeine); and (b) Topical medicines for dermal application that are directed for use in adults only. When for topical application: (a) the concentration of total caffeine in the medicine must not be more than 1%; and (b) the medicine must not be intended for use on broken skin. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 100 mg of caffeine from this ingredient. When for internal use or oral application, the following warning statement is required on the medicine label: - (ADULT) 'Adults only' (or words to that effect). When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80 mg of caffeine.' - (CAFFPREG) 'Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.' When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.' - (CAFFCYP) 'Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines' (or words to that effect). 1055 CAJUPUT OIL A, E, H Cineole is a mandatory component of Cajuput oil. When the concentration in the medicine is more than 25%, the nominal capacity of the container must be no more than 25 mL. When the concentration in the medicine is more than 25% and the nominal capacity of the container is more than 15 mL, a child resistant closure and restricted flow insert must be fitted on the container. When the concentration in the medicine is more than 25% and the nominal capacity of the container is less than 15 mL, a restricted flow insert must be fitted to the container. When the concentration in the medicine is more than 25%, the medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect) - (NTAKEN) 'Not to be taken'. When the concentration of cineole in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 mL. When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL but no more than 25mL, the medicine must have a child resistant closure and restricted flow insert fitted on the container and the medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect) - (NTAKEN) 'Not to be taken'. When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 mL, the medicine must have the restricted flow insert fitted on the container and the medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect) - (NTAKEN) 'Not to be taken'. 1056 CALAMINE A, E Only for use as an active or excipient ingredient for dermal application. When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 1057 CALANUS FINMARCHICUS OIL A Only to be used in a medicine where Blackmores Ltd (Client ID 10576), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 1 March 2025. The route of administration for medicines that contain Calanus finmarchicus oil must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 2.3 g of Calanus finmarchicus oil. The following warning statements (or words to that effect) are required on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women'; and - (ADULT) 'Adults only'. 1058 CALCIFEDIOL MONOHYDRATE A The maximum recommended daily dose of the medicine must not provide more than 10 micrograms of calcifediol. Only for use in oral medicines. Calcifediol must not be used in medicines with other Vitamin D analogues; such as ergocalciferol or colecalciferol. The medicine requires the following warning statements on the label: - (CFEDIOL) 'Calcifediol may have similar effects to Vitamin D. Consult your health care professional before taking in combination with other medicines.' (or words to that effect); - (OTHVITD) 'The medicine should not be taken in combination with supplements containing Vitamin D without medical advice' (or words to that effect); - (CHILD9) 'Use in children under 9 years is not recommended' (or words to that effect). 1059 CALCIFIED LITHOTHAMNION SPECIES A Only for use in oral medicines. 1060 CALCIFIED LITHOTHAMNION TOPHIFORME A Only for oral use. 1061 CALCIUM ALGINATE E 1062 CALCIUM AMINO ACID CHELATE A, H Calcium is a mandatory component of calcium amino acid chelate. The concentration of calcium in the calcium amino acid chelate must be no more than 25% w/w. 1063 CALCIUM ASCORBATE A, E, H 1064 CALCIUM ASCORBATE DIHYDRATE A, E, H 1065 CALCIUM ASPARTATE A 1066 CALCIUM ASPARTATE HYDROCHLORIDE DIHYDRATE A Only for use in oral medicines. 1067 CALCIUM BEHENATE E Behenic acid is a mandatory component of Calcium behenate. When for oral ingestion, the maximum recommended daily dose must not provide more than 383.5 mg of Behenic acid. 1068 CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE A, H 1069 CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE A, H 1070 CALCIUM CARBONATE A, E, H 1071 CALCIUM CASEINATE E 1072 CALCIUM CHLORIDE DIHYDRATE E 1073 CALCIUM CITRATE A, E, H 1074 CALCIUM CITRATE TETRAHYDRATE A, E, H 1075 CALCIUM DIASPARTATE A Only for use in oral medicines. 1076 CALCIUM FLUORIDE H The percentage of fluoride from Calcium fluoride should be calculated based on the molecular weight of Calcium fluoride. The concentration of fluoride in the product from all ingredients must be no more than 10mg/kg or 10mg/L or 0.1%. 1077 CALCIUM FOLINATE A Folinic acid is a mandatory component of calcium folinate. The maximum recommended daily dose must not provide more than 500 micrograms of folinic acid. When the medicine contains a combination of folic acid, folinic acid or levomefolic acid, the medicine must not provide more than a combined total of 500 micrograms of folic acid, folinic acid and levomefolic acid per maximum recommended daily dose. 1078 CALCIUM FRUCTOBORATE TETRAHYDRATE A Only to be used in a medicine where VDF FutureCeuticals Inc (Client ID 62256), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 25 October 2025. Boron is a mandatory component of calcium fructoborate tetrahydrate. The percentage of boron from calcium fructoborate tetrahydrate should be calculated based on the molecular weight of calcium fructoborate tetrahydrate. The route of administration for medicines that contain calcium fructoborate tetrahydrate must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than: (a) 220 mg of calcium fructoborate tetrahydrate; and (b) 6 mg of boron. The following warning statements (or words to the same effect) are required on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women'; and - (ADULT) 'Adults only'. 1079 CALCIUM GLUCONATE MONOHYDRATE A, E, H 1080 CALCIUM GLYCEROPHOSPHATE A, E, H 1081 CALCIUM GLYCINATE A Only for use in oral medicines. 1082 CALCIUM GLYCINATE DIHYDRATE A 1083 CALCIUM HEXAFLUOROSILICATE H Only for use as an active homoeopathic ingredient. 1084 CALCIUM HYDROGEN PHOSPHATE A, E, H 1085 CALCIUM HYDROGEN PHOSPHATE DIHYDRATE A, E, H 1086 CALCIUM HYDROGEN PHOSPHATE MONOHYDRATE A, E, H 1087 CALCIUM HYDROXIDE A, E, H When used as a standard active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia as in force or existing from time to time. 1088 CALCIUM HYDROXYCITRATE A, H The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. When for oral use, the following warning statement is required on the medicine label: 'In very rare cases, calcium hydroxycitrate may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.' Medicines containing calcium hydroxycitrate must not be directed for use in children, or in pregnant or lactating women. 1089 CALCIUM HYPOPHOSPHITE H Only for use as an active homoeopathic ingredient. 1090 CALCIUM IODIDE H Only for use as an active homoeopathic ingredient. 1091 CALCIUM KETOGLUCONATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration must be no more than 1% 1092 CALCIUM L-THREONATE A Only for use in oral medicines. 1093 CALCIUM LACTATE A, E, H 1094 CALCIUM LACTATE GLUCONATE A, E, H 1095 CALCIUM LACTATE PENTAHYDRATE A, E, H 1096 CALCIUM LACTATE TRIHYDRATE A, E, H 1097 CALCIUM LYSINATE A Only for use in oral medicines. 1098 CALCIUM METHIONINATE A Only for use in oral medicines. 1099 CALCIUM OROTATE A, E, H 1100 CALCIUM OXIDE E Only for use in topical medicines for dermal application. 1101 CALCIUM PANTOTHENATE A, E, H 1102 CALCIUM PHOSPHATE A, E, H 1103 CALCIUM PROPIONATE E Only to be used in a medicine where Procter & Gamble Australia Pty Ltd (Client ID 11364), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 1 March 2027. The route of administration for medicines that contain calcium propionate must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 1 milligram of calcium propionate. 1104 CALCIUM PYRUVATE A 1105 CALCIUM SACCHARATE E 1106 CALCIUM SILICATE E 1107 CALCIUM SODIUM CASEINATE A, H 1108 CALCIUM SODIUM LACTATE A, E, H 1109 CALCIUM STEARATE E 1110 CALCIUM SUCCINATE A, E, H 1111 CALCIUM SULFATE A, E, H 1112 CALCIUM SULFATE DIHYDRATE A, E, H 1113 CALCIUM SULFIDE H Only for use as an active homoeopathic ingredient. 1114 CALCIUM THREONINATE A 1115 CALENDULA FLOWER DRY A, E, H 1116 CALENDULA FLOWER POWDER A, H 1117 CALENDULA OFFICINALIS A, E, H 1118 CALLERYA RETICULATA A, H 1119 CALLICARPA PEDUNCULATA A, H 1120 CALLISTEPHUS CHINENSIS A, H 1121 CALLITRIS COLUMELLARIS E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1122 CALLITRIS COLUMELLARIS SUBSP. INTRATROPICA E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1123 CALLITRIS RHOMBOIDEA A, H 1124 CALLUNA VULGARIS A, E, H 1125 CALOCHORTUS TOLMIEI A, H 1126 CALTHA PALUSTRIS A, H 1127 CALUMBA ROOT DRY A, H 1128 CALUMBA ROOT POWDER A, H 1129 CALVATIA GIGANTEA A, E, H 1130 CALYCANTHUS FLORIDUS A, H 1131 CALYCANTHUS PRAECOX A, H 1132 CAMELLIA JAPONICA A, H 1133 CAMELLIA OLEIFERA A, E, H If Camellia oleifera (seed oil) is used as a solvent, it is restricted to topical or sunscreen preparations for dermal application only. 1134 CAMELLIA SINENSIS A, E, H Caffeine is a mandatory component of Camellia sinensis. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: - (ADULT) 'Adults only' (or words to that effect). - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.' - (CAFFPREG) 'Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.' When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.' - (CAFFCYP) 'Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines' (or words to that effect). When used in oral medicines, the following warning statements are required on the medicine label: - 'In rare cases, Camellia sinensis may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes, or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.'; and - (FOOD) 'To be taken with food.' unless when: (a) the preparation of Camellia sinensis is derived from an aqueous extract and contains 300 mg or less epigallocatechin-3-gallate per maximum recommended daily dose; or (b) Camellia sinensis is used in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing Camellia sinensis must not be more than 5% of the total medicine. 1135 CAMPHENE E Permitted for use only in combination with other permitted ingredients as a coating solution, a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1136 CAMPHOLENIC ALDEHYDE E Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. 1137 CAMPHOR A, E, H In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%. In liquid preparations, the concentration of camphor must be no more than 2.5%. 1138 CAMPHOR BENZALKONIUM METHOSULFATE A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the preparation must not be more than 6%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 1139 CAMPHOR OIL BROWN A, H Camphor, cineole and safrole are mandatory components of camphor oil brown. In solid and semi solid preparations, the concentration of camphor must not be more than 12.5%. In liquid preparations other than essential oils, the concentration of camphor must not be more than 2.5%. In essential oil preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect). In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect). In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect). When the concentration of cineole in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres. When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is not more than 15 millilitres, the medicine must have the restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. When for internal use the concentration of safrole in a medicine must not be more than 0.1%. When for topical use the concentration of safrole in a medicine must not be more than 1.0%. If the concentration of camphor is more than 2.5%, the nominal capacity of the container must not be more than 25 millilitres. 1140 CAMPHOR OIL WHITE A, E, H Camphor and safrole are mandatory components of camphor oil white. In solid and semi solid preparations, the concentration of camphor must not be more than 12.5%. In liquid preparations other than essential oils, the concentration of camphor must not be more than 2.5%. In essential oil preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect). In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect). In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect). When for internal use the concentration of safrole in a medicine must not be more than 0.1%. When for topical use the concentration of safrole in a medicine must not be more than 1.0%. If the concentration of camphor is more than 2.5%, the nominal capacity of the container must not be more than 25 millilitres. 1141 CAMPSIS GRANDIFLORA A, H 1142 CANADA BALSAM A, H 1143 CANANGA ODORATA A, E, H 1144 CANANGA OIL A, E, H 1145 CANARIUM INDICUM A, H Only for use when the plant part is seed and the plant preparation is oil. 1146 CANARIUM LUZONICUM A, H 1147 CANDELILLA WAX A, E, H 1148 CANDIDA ALBICANS H Only for use as an active homoeopathic ingredient. 1149 CANDIDA UTILIS A, E, H When used as an excipient, only for use in medicines in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must not be more than 5%. 1150 CANINE MILK H Only for use as an active homoeopathic ingredient. 1151 CANOLA OIL A, E, H Allyl isothiocyanate is a mandatory component of canola oil when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 1152 CANTHARIDES H Only available as an active homoeopathic ingredient. 1153 CANTHAXANTHIN E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 1154 CAPRIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1155 CAPROIC ALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1156 CAPRYLIC ALDEHYDE E Permitted for use only in combination with other permitted ingredients as a coating solution, a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1157 CAPRYLIC/CAPRIC/ISOSTEARIC/ADIPIC TRIGLYCERIDE E 1158 CAPRYLIC/CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine is not to exceed 3% 1159 CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE E Only for use in topical medicines for dermal application. 1160 CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. 1161 CAPRYLOYL GLYCINE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 2% 1162 CAPRYLOYL SALICYLIC ACID E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must not be more than 0.3%. 1163 CAPRYLYL GLYCOL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2% 1164 CAPRYLYL METHICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. 1165 CAPSELLA BURSA-PASTORIS A, H 1166 CAPSICUM E, H Only for use as an active homoeopathic or excipient ingredient. 1167 CAPSICUM ANNUUM A, E, H 1168 CAPSICUM DRY A, E, H 1169 CAPSICUM FRUIT OLEORESIN A, E 1170 CAPSICUM FRUTESCENS A, E, H 1171 CAPSICUM POWDER A, E, H 1172 CARALLUMA ADSCENDENS VAR. FIMBRIATA A The plant part must be herb and the plant preparation must be a hydroethanolic extract. 1173 CARAMEL E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 1174 CARAPICHEA IPECACUANHA A, H Emetine is a mandatory component of Carapichea ipecacuanha. The concentration of emetine in the medicine must not be more than 0.2%. 1175 CARAWAY DRY A, H 1176 CARAWAY OIL A, E, H 1177 CARAWAY POWDER A, H 1178 CARBOMER 1342 E Only for use as an excipient in topical medicines for dermal application. 1179 CARBOMER 2001 E Only for use as an excipient ingredient in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration must be no more than 1% in formulations at pH 7 (approximately neutral) and 0.1% in formulations at a different pH. 1180 CARBOMER 934 E Only for use in topical medicines for dermal application. 1181 CARBOMER 934P E Only for use in topical medicines for dermal application. 1182 CARBOMER 940 E Only for use in topical medicines for dermal application. 1183 CARBOMER 941 E Only for use as an excipient in topical medicines for dermal application. 1184 CARBOMER 954 E Only for use as an excipient in topical medicines for dermal application. 1185 CARBOMER 980 E Only for use as an excipient in topical medicines for dermal application. 1186 CARBOMER 981 E Only for use as an excipient in topical medicines for dermal application. 1187 CARBOMER COPOLYMER (TYPE B) E Only for use as an excipient in topical medicines for dermal application. 1188 CARBOMER HOMOPOLYMER (TYPE B) E Only for use as an excipient in topical medicines for dermal application. 1189 CARBOMER U-10 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 1190 CARBON E, H Only for use as an active homoeopathic or excipient ingredient. 1191 CARBON BLACK E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 1192 CARBON DIOXIDE E 1193 CARDAMOM FRUIT DRY A, H 1194 CARDAMOM FRUIT POWDER A, E, H 1195 CARDAMOM OIL A, E, H 1196 CARDIOSPERMUM HALICACABUM A, H 1197 CARICA PAPAYA A, E, H 1198 CARLINA ACAULIS A, H 1199 CARMELLOSE E 1200 CARMELLOSE CALCIUM E 1201 CARMELLOSE SODIUM E 1202 CARMINE E Permitted for use only as a colour for oral and topical use. 1203 CARMOISINE E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 1204 CARMOISINE ALUMINIUM LAKE E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 1205 CARNAUBA WAX A, E, H 1206 CARNOSINE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. 1207 CAROB BEAN EXTRACT E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1208 CAROB GUM E 1209 CAROB POD E 1210 CAROTENES E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 1211 CARPINUS BETULUS A, H 1212 CARPINUS CORDATA A, H 1213 CARRAGEENAN E 1214 CARROT E 1215 CARROT SEED OIL A, E, H 1216 CARTHAMUS TINCTORIUS A, E, H Carthamus tinctorius (safflower oil) when used as a solvent is restricted to topical or sunscreen preparations for dermal application only. If for oral use, the medicine requires the following warning statement on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect). 1217 CARUM CARVI A, H 1218 CARVACROL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1219 CARVACRYL METHYL ETHER E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1220 CARVEOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1221 CARVONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1222 CARVYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1223 CARYA ILLINOINENSIS A, H 1224 CARYA OVATA A, H 1225 CARYOPHYLLENE OXIDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1226 CASCARA DRY A, H Hydroxyanthracene derivatives calculated as cascaroside A is a mandatory component of cascara dry when the route of administration is oral. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect]. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' [or words to that effect]. When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' [or words to that effect]; and - (LAX2) 'Prolonged use may cause serious bowel problems'. 1227 CASCARA POWDER A, H Hydroxyanthracene derivatives calculated as cascaroside A is a mandatory component of cascara powder when the route of administration is oral administration. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 1228 CASCARILLA OIL A, E, H The medicine must not contain more than 1 mg of the equivalent dry herbal material per the maximum recommended daily dose. When for use as an excipient ingredient, cascarilla oil must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing cascarilla oil must not be more than 5% of the total medicine. 1229 CASEIN E 1230 CASHEW NUT E 1231 CASSIA ALATA LEAF EXTRACT E Only for use as an excipient ingredient in sunscreens for dermal application and not to be intended for use in the eye. The extraction ratio of the Cassia alata can only be 1:3 in 62.5% glycerine:water. The concentration in the medicine must be no more than 0.0275%. 1232 CASSIA CINNAMON BARK DRY A, H When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%. 1233 CASSIA CINNAMON BARK POWDER A, H When used as an active ingredient, the maximum daily dose of the medicine must contain no more than 0.001% of coumarin. 1234 CASSIA FISTULA A, E, H Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Cassia fistula when the route of administration is oral. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. When Cassia fistula is for use as an excipient: (a) the plant part must be fruit; and (b) must only be included in medicines when in combination with other permitted ingredients as a: (i) flavour proprietary excipient formulation when the plant preparation is an extract; and/or (ii) fragrance proprietary excipient formulation when the plant preparation is an essential oil. The total concentration of flavour proprietary excipient formulations containing Cassia fistula must not be more than 5% of the total medicine. The total concentration of fragrance proprietary excipient formulations containing Cassia fistula must not be more than 1% of the total medicine. 1235 CASSIA OIL A, E, H The concentration of Cassia oil in the product must be no more than 2% unless the preparation is for dermal use as a rubefacient, in which case the concentration of cassia oil must be no more than 5%. 1236 CASSIE ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1237 CASTANEA MOLLISSIMA A, H 1238 CASTANEA SATIVA A, H 1239 CASTOR OIL A, E 1240 CASTOREUM H Only permitted for use as an active homoeopathic ingredient. 1241 CASUARINA EQUISITIFOLIA A, H 1242 CATALPA BIGNONIOIDES A, H 1243 CATALPA OVATA A, H 1244 CATECHU A, H 1245 CATHARANTHUS ROSEUS A, H Vinblastine, vincamine, vincristine, vindesine, vinorelbine and yohimbine are mandatory components of Catharanthus roseus. The concentration of vinblastine, vincamine, vincristine, vindesine, vinorelbine and yohimbine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%. 1246 CAULIFLOWER E 1247 CAULOPHYLLUM THALICTROIDES A, E, H 1248 CAUSTICUM H Only for use as an active homoeopathic ingredient. 1249 CEANOTHUS AMERICANUS A, H 1250 CEDAR LEAF OIL A, E, H 1251 CEDARWOOD OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1252 CEDARWOOD OIL TERPENES E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1253 CEDARWOOD OIL VIRGINIA E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1254 CEDRENOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1255 CEDRENYLACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1256 CEDROL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1257 CEDRUS ATLANTICA A, E, H 1258 CEDRUS ATLANTICA WOOD OIL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1259 CEDRUS DEODARA A, H 1260 CEDRUS LIBANI H Only for use as an active homoeopathic ingredient. 1261 CEDRYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1262 CEDRYL METHYL ETHER E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1263 CELERY SEED DRY A, E, H 1264 CELERY SEED OIL A, E, H 1265 CELERY SEED POWDER A, H 1266 CELLACEFATE E 1267 CELLULASE A Must be derived from Trichoderma longibrachiatum only. 1268 CELLULOSE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1269 CELOSIA ARGENTEA A, H 1270 CELOSIA ARGENTEA L. VAR. CRISTATA A, H 1271 CENTAUREA CYANUS A, E, H 1272 CENTAURIUM ERYTHRAEA A, H 1273 CENTELLA ASIATICA A, E, H 1274 CENTELLA ASIATICA MERISTEM CELL CULTURE E Only for use as an excipient ingredient in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.05%. 1275 CENTIPEDA CUNNINGHAMII A, E, H 1276 CENTIPEDA MINIMA A, H 1277 CEPHALANOPSIS SEGETUM A, H 1278 CERAMIDE 1 E Only for use in topical medicines for dermal application. 1279 CERAMIDE 2 E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 0.05%. 1280 CERAMIDE 3 E Only for use in topical medicines for dermal application. 1281 CERAMIDE 6 II E Ceramide 6 II must: (a) Only be used in topical medicines for dermal application; and (b) Not be included in medicines intended for use on broken skin or in the eye. The concentration in the medicine must be no more than 0.011%. 1282 CERATONIA SILIQUA A, E, H 1283 CERATOSTIGMA WILLMOTTIANUM A, H 1284 CERESIN E Only for use in topical medicines for dermal application. 1285 CESTRUM LATIFOLIUM E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The plant part must be leaf and must be a water extract. The concentration must be no more than 0.5%. 1286 CETEARETH-12 E Only for use in topical medicines for dermal application. 1287 CETEARETH-2 E Only for use in topical medicines for dermal application. 1288 CETEARETH-20 E Only for use in topical medicines for dermal application. 1289 CETEARETH-25 E Only for use in topical medicines for dermal application. 1290 CETEARETH-30 E Only for use in topical medicines for dermal application. 1291 CETEARETH-33 E Only for use as an excipient ingredient for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. Residual levels of 1,4-dioxane oxide (and related substances) are to be kept below the level of detection. 1292 CETEARYL GLUCOSIDE E Only for use in topical medicines for dermal application. 1293 CETEARYL ISONONANOATE E Only for use in topical medicines for dermal application. 1294 CETEARYL NONANOATE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must not be more than 5%. 1295 CETEARYL OCTANOATE E Only for use in topical medicines for dermal application. 1296 CETETH-10 E Only for use in topical medicines for dermal application. 1297 CETETH-2 E Only for use in topical medicines for dermal application. 1298 CETETH-24 E Only for use in topical medicines for dermal application. 1299 CETETH-5 E Only for use in topical medicines for dermal application. 1300 CETOMACROGOL 1000 E Only for use in topical medicines for dermal application. 1301 CETOMACROGOL 1000 PHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. 1302 CETOMACROGOL 500 PHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. 1303 CETOSTEARYL ALCOHOL E 1304 CETOSTEARYL ALCOHOL/COCO-GLUCOSIDE COMPLEX E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 5.0 % 1305 CETRARIA ISLANDICA A, H 1306 CETRIMONIUM BROMIDE E Only for use in topical medicines for dermal application. 1307 CETRIMONIUM CHLORIDE E Only for use in topical medicines for dermal application. 1308 CETYL ACETATE E Only for use in topical medicines for dermal application. 1309 CETYL ALCOHOL E Only for use in topical medicines for dermal application. 1310 CETYL DIMETHICONE COPOLYOL E Only for use in topical medicines for dermal application. 1311 CETYL DIMETICONE E Only for use in topical medicines for dermal application. 1312 CETYL DIMETICONE/BIS-VINYLDIMETICONE CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.1%. 1313 CETYL ESTERS WAX E Only for use in topical medicines for dermal application. 1314 CETYL HYDROXYETHYLCELLULOSE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 1315 CETYL LACTATE E Only for use in topical medicines for dermal application. 1316 CETYL OCTANOATE E Only for use in topical medicines for dermal application. 1317 CETYL PALMITATE E Only for use in topical medicines for dermal application. 1318 CETYL PHOSPHATE E Only for use in topical medicines for dermal application. 1319 CETYL-PG HYDROXYETHYL PALMITAMIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 8%. 1320 CETYLPYRIDINIUM CHLORIDE A, E Only permitted for use in medicines containing 5% or less of quaternary ammonium compounds. When used as an excipient ingredient, only for use in topical medicines for dermal application. When used as an active ingredient: (a) permitted for use only in medicated throat lozenges; (b) the medicine must not contain more than 2 milligrams of cetylpyridinium chloride per lozenge; (c) the maximum recommended daily dose of the medicine must not provide more than 24 milligrams of cetylpyridinium chloride; and (d) the medicine label must specify that the medicine is only to be used for 7 days (or less). 1321 CHAENOMELES LAGENARIA A, H 1322 CHAENOMELES SPECIOSA A, H 1323 CHALK A, E When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 1324 CHAMAECYPARIS LAWSONIANA A, H 1325 CHAMAELIRIUM LUTEUM A, H 1326 CHAMAEMELUM NOBILE A, E, H 1327 CHAMOMILE FLOWER DRY A, E, H 1328 CHAMOMILE OIL ENGLISH A, E, H 1329 CHAMOMILE OIL GERMAN A, E, H 1330 CHANGIUM SMYRNIOIDES A, H 1331 CHEIRANTHUS CHEIRI A, H 1332 CHELIDONIUM MAJUS A, E, H When the medicine is for oral or sublingual use, the following warning statement is required on the medicine label: (CELAND1) 'In rare cases, Chelidonium majus may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine.' 1333 CHELONE GLABRA A, H 1334 CHENOPODIUM ALBUM A, H 1335 CHENOPODIUM VULVARIA A, H 1336 CHERRY E 1337 CHERRY DISTILLATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1338 CHESTNUT SWEET E, H 1339 CHICKEN COMB EXTRACT A 1340 CHICKEN STERNUM CARTILAGE POWDER A Only to be used in a medicine where Capsugel Australia Pty Ltd (Client ID 43174), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 3 July 2025. The route of administration for medicines that contain chicken sternum cartilage powder must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 40 mg of chicken sternum cartilage powder. The following warning statement (or words to that effect) is required on the medicine label: - (ADULT) 'Adults only'. 1341 CHIMAPHILA UMBELLATA A, H Beta-arbutin is a mandatory component of Chimaphila umbellata. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 1342 CHIONANTHUS VIRGINICA A, H 1343 CHLORELLA E Iodine is a mandatory component of Chlorella. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 1344 CHLORELLA PYRENOIDOSA E 1345 CHLORELLA VULGARIS A, E Iodine is a mandatory component of Chlorella vulgaris. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 1346 CHLORHEXIDINE ACETATE E Only for use in topical medicines for dermal application. 1347 CHLORHEXIDINE GLUCONATE E Only for use in topical medicines for dermal application. 1348 CHLOROBUTANOL HEMIHYDRATE E Only for use in topical preparations for dermal application. The concentration in the medicine must be no more than 0.5%. 1349 CHLOROCRESOL E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 3%. 1350 CHLOROFORM E The residual solvent limit must be no more than 0.6 mg per recommended daily dose and the concentration in the medicine must be no more than 0.006%. 1351 CHLOROPHYLL A, E Only for use as a colour in oral and topical medicines. 1352 CHLOROPHYLL-COPPER COMPLEXES E Only for use as a colour in oral and topical medicines. 1353 CHLOROPHYLLIN-COPPER COMPLEX E Only for use as a colour in oral and topical medicines. 1354 CHLOROPHYLLIN-COPPER COMPLEX ALUMINIUM LAKE E Only for as a colour in oral and topical medicines. 1355 CHLOROXYLENOL E Only for use in topical medicines for dermal application. 1356 CHLORPHENESIN E Only for use in topical medicines for dermal application. 1357 CHOCOLATE BROWN HT E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 1358 CHOLESTEROL E, H Only for use as an active ingredient in homoeopathic medicines or an excipient ingredient in topical preparations. 1359 CHOLESTERYL HYDROXYSTEARATE E Only for use in topical medicines for dermal application. 1360 CHOLESTERYL MACADAMIATE E Only for use in topical medicines for dermal application. 1361 CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 1362 CHOLETH-24 E Only for use in topical medicines for dermal application. 1363 CHOLINE BITARTRATE A, E 1364 CHOLINE DIHYDROGEN CITRATE A Only for use in oral medicines. 1365 CHONDRODENDRON TOMENTOSUM A, H The concentration of equivalent dry Chondrodendron tomentosum in the product must be no more than 10mg/Kg or 10mg/L or 0.001%. 1366 CHONDRUS CRISPUS A, E, H Iodine is a mandatory component of Chondrus crispus. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 1367 CHONDRUS DRY A, E, H Iodine is a mandatory component of Chondrus dry. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 1368 CHONDRUS EXTRACT A, E, H Iodine is a mandatory component of Chondrus extract. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 1369 CHROMIC CHLORIDE HEXAHYDRATE A, H When used as an active ingredient in a preparation for mineral supplementation, chromium is a mandatory component of chromic chloride hexahydrate. The amount of chromium in the active ingredient should be calculated based on the molecular weight of chromic chloride hexahydrate. The maximum recommended daily dose must provide 50 micrograms or less of chromium from organic sources (i.e. chromium picolinate, chromium nicotinate and high chromium yeast). 1370 CHROMIUM NICOTINATE A Chromium is a mandatory component of chromium nicotinate. The maximum recommended daily dose must not provide more than 50 micrograms of chromium from organic sources. Chromium nicotinate is considered to be an organic form of chromium. 1371 CHROMIUM PICOLINATE A Chromium is a mandatory component of Chromium picolinate. The maximum recommended daily dose must not provide more than 50 micrograms of chromium from organic sources. Chromium picolinate is considered to be an organic form of chromium. 1372 CHRYSANTHEMUM BALSAMITA A, H 1373 CHRYSANTHEMUM INDICUM A, H 1374 CHRYSANTHEMUM LEUCANTHEMUM A, H 1375 CHRYSANTHEMUM SINENSE A, H 1376 CHRYSOPOGON ZIZANIOIDES A, E, H 1377 CHRYSOSPORIUM PRUINOSUM A, H 1378 CIBOTIUM BAROMETZ A, H 1379 CICHORIUM INTYBUS A, E, H 1380 CICUTA VIROSA A, H The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material. 1381 CINCHONA BARK DRY A, H Quinidine and quinine are mandatory components of Cinchona bark dry. The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL. 1382 CINCHONA BARK POWDER A, H Quinidine and quinine are mandatory components of Cinchona bark powder. The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL. 1383 CINCHONA OFFICINALIS A, H Quinidine and quinine are mandatory components of Cinchona officinalis. The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL. 1384 CINCHONA PUBESCENS A, H Quinidine and quinine are mandatory components of Cinchona pubescens. The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL. 1385 CINEOLE E In liquid preparations when the concentration of cineole in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 1386 CINNAMALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1387 CINNAMIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1388 CINNAMOMUM CAMPHORA A, E, H Camphor, cineole and safrole are mandatory components of Cinnamomum camphora. In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%. In liquid preparations other than essential oils or distillates, the concentration of camphor must be no more than 2.5%. In essential oil preparations or distillates and the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25 millilitres and the following warning statements must be included on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist'. In essential oil preparations or distillates, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container. In essential oil preparations or distillates, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container. In essential oil preparations or distillates, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container. In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% the nominal capacity of the container must be no more than 25 millilitres and the medicine must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container. In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container. When for internal use then the concentration of safrole in a medicine must be no more than 0.1%. When for uses other than internal use, the concentration of safrole in a medicine must be no more than 1.0%. When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%. 1389 CINNAMOMUM CASSIA A, E Cassia oil is a mandatory component of Cinnamomum cassia if the plant preparation is an essential oil, distillate, fixed oil or infused oil. The concentration of Cassia oil in the medicine must be no more than 2%. When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%. 1390 CINNAMOMUM VERUM A, E, H When used as an active ingredient coumarin is a mandatory component of Cinnamomum verum and the concentration of coumarin in the medicine must be no more than 0.001%. Cinnamon bark oil is a mandatory component of Cinnamomum verum when the plant part is bark and the plant preparation is essential oil, distillate, fixed oil or infused oil. The concentration of cinnamon bark oil in the medicine must be no more than 2%. Cinnamon leaf oil is a mandatory component of Cinnamomum verum when the plant part is leaf. When the concentration of cinnamon leaf oil in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but no more than 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container. When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the container must be fitted with a restricted flow insert. 1391 CINNAMON BARK OIL A, E, H The concentration of cinnamon bark oil in the product must be no more than 2%. When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%. 1392 CINNAMON DRY A, H Cinnamon bark oil is a mandatory component of cinnamon dry. The concentration of cinnamon bark oil in the product must be no more than 2%. When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%. 1393 CINNAMON LEAF OIL A, E, H When the concentration of cinnamon leaf oil in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 mL. When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL but no more than 25mL, the medicine must have a child resistant closure and restricted flow insert fitted on the container and requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). - (NTAKEN) 'Not to be taken'. When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is no more than 15 mL, the container must be fitted with a restricted flow insert and requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). - (NTAKEN) 'Not to be taken'. When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%. 1394 CINNAMON POWDER A, E, H Cinnamon bark oil is a mandatory component of cinnamon powder. The concentration of cinnamon bark oil in the product must be no more than 2%. When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%. 1395 CINNAMYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1396 CINNAMYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1397 CINNAMYL BUTYRATE E If used in a flavour the total flavour concentration in a medicine must be no more than 5%. Permitted for use only in combination with other permitted ingredients as a flavour. 1398 CINNAMYL CINNAMATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1399 CINNAMYL FORMATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1400 CINNAMYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1401 CINNAMYL ISOVALERATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. 1402 CINNAMYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1403 CINOXATE A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 6%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 1404 CIS-2-METHYL-4-PROPYL-1,3-OXATHIANE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1405 CIS-3-HEXEN-1-OL E cis-3-Hexen-1-ol must only be included in medicines when in combination with other permitted ingredients as a flavour or fragrance proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing cis-3-hexen-1-ol must not be more than 5% of the total medicine. The total concentration of fragrance proprietary excipient formulations containing cis-3-hexen-1-ol must not be more than 1% of the total medicine. 1406 CIS-3-HEXENAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1407 CIS-3-HEXENYL 2-METHYLBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1408 CIS-3-HEXENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1409 CIS-3-HEXENYL BENZOATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1410 CIS-3-HEXENYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1411 CIS-3-HEXENYL FORMATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1412 CIS-3-HEXENYL HEXANOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1413 CIS-3-HEXENYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1414 CIS-3-HEXENYL ISOVALERATE E If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. 1415 CIS-3-HEXENYL LACTATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1416 CIS-3-HEXENYL METHYL CARBONATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1417 CIS-3-HEXENYL SALICYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1418 CIS-3-HEXENYL TIGLATE E Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 1419 CIS-4-HEPTENAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1420 CIS-6-NONEN-1-AL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1421 CIS-6-NONENOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1422 CIS-BETA-OCIMENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1423 CIS-HEXAHYDROCUMINYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1424 CIS-JASMONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1425 CISTANCHE DESERTICOLA A, H 1426 CISTANCHE SALSA A, H 1427 CISTUS LADANIFER A, E, H 1428 CITRAL E 1429 CITRAL DIETHYL ACETAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1430 CITRAL DIMETHYL ACETAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1431 CITRIC ACID A, E Where intended for topical use, sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose. When used as an active ingredient in preparations for topical use, the medicine requires the following warning statements on the medicine label: - (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect) - (SUNPRO) 'Wear protective clothing, hats and eyewear when exposed to the sun.' (or words to that effect) - (IRRIT) 'If irritation develops, discontinue use.' - (SKTEST) 'If you have sensitive skin, test this product on a small area of skin before applying it to a large area.' - (CHILD3) 'Use in children under 12 years is not recommended' 1432 CITRIC ACID DIHYDRATE A, E Where intended for topical use, sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose. When used as an active ingredient in preparations for topical use, the medicine requires the following warning statements on the medicine label: - (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect) - (SUNPRO) 'Wear protective clothing, hats and eyewear when exposed to the sun.' (or words to that effect) - (IRRIT) 'If irritation develops, discontinue use.' - (SKTEST) 'If you have sensitive skin, test this product on a small area of skin before applying it to a large area.' - (CHILD3) 'Use in children under 12 years is not recommended' 1433 CITRIC ACID MONOHYDRATE A, E Where intended for topical use, sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose. When used as an active ingredient in preparations for topical use, the medicine requires the following warning statements on the medicine label: - (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect) - (SUNPRO) 'Wear protective clothing, hats and eyewear when exposed to the sun.' (or words to that effect) - (IRRIT) 'If irritation develops, discontinue use.' - (SKTEST) 'If you have sensitive skin, test this product on a small area of skin before applying it to a large area.' - (CHILD3) 'Use in children under 12 years is not recommended.' 1434 CITRIC AND FATTY ACID ESTERS OF GLYCEROL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1435 CITROL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1436 CITRON E 1437 CITRONELLA OIL A, E, H Medicines for topical use containing citronella oil require the following warning statement on the medicine label: - (CITRON) 'Contains citronella oil'. 1438 CITRONELLA TERPENES E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1439 CITRONELLAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1440 CITRONELLIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1441 CITRONELLOL E Permitted for use only: (a) in topical medicines for dermal application; and (b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. 1442 CITRONELLYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1443 CITRONELLYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1444 CITRONELLYL FORMATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1445 CITRONELLYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1446 CITRONELLYL NITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1447 CITRONELLYL OXYACETALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1448 CITRONELLYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1449 CITRONELLYL TIGLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1450 CITRULLINE A Only permitted for use in medicines: (a) limited to oral routes of administration; and (b) when the maximum recommended daily dose does not provide more than 6 g of citrulline. 1451 CITRULLUS COLOCYNTHIS H Citrullus colocynthis can only be included in medicines for oral use when the dilution of the mother tincture is 10,000 fold (4X) or more. 1452 CITRULLUS VULGARIS A, E, H When used as an excipient: a) the plant part must be from fruit or fruit fresh, and b) the plant preparation must be limited to fresh, dry, powder, oil, fresh juice, dry juice, or concentrated juice. 1453 CITRUS AURANTIFOLIA A, E, H When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) in preparations containing 0.5% or less of citrus aurantifolia oil or distillate; or c) for use in soaps or bath or shower gels that are washed off the skin. 1454 CITRUS AURANTIUM A, E, H Oxedrine is a mandatory component of Citrus aurantium when intended for internal use. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 mg. When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) in preparations containing 1.4% or less of citrus aurantium oil or distillate; or c) for use in soaps or bath or shower gels that are washed off the skin. 1455 CITRUS BIOFLAVONOIDS EXTRACT A, E, H 1456 CITRUS CHACHIENSIS A, H 1457 CITRUS EXTRACT E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1458 CITRUS FIBRE E 1459 CITRUS LIMETTA A, H When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) in preparations containing 0.5% or less of citrus limetta oil or distillate; or c) for use in soaps or bath or shower gels that are washed off the skin. 1460 CITRUS LIMON A, E, H Oxedrine is a mandatory component of Citrus limon when intended for internal use. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) in preparations containing 0.05% or less of citrus limon oil or distillate; or c) for use in soaps or bath or shower gels that are washed off the skin. 1461 CITRUS MAXIMA A, H 1462 CITRUS MEDICA A, E, H When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) in preparations containing 0.05% or less of citrus medica oil or distillate; or c) for use in soaps or bath or shower gels that are washed off the skin. 1463 CITRUS OIL DISTILLED E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1464 CITRUS OIL TERPENES AND TERPENOIDS E Citrus oil terpenes and terpenoids must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing citrus oil terpenes and terpenoids must not be more than 1% of the total medicine. 1465 CITRUS RETICULATA A, E, H Oxedrine is a mandatory component of Citrus reticulata when intended for internal use. The quantity of Oxedrine in the recommended daily dose must be no more than 30 mg. 1466 CITRUS SINENSIS A, E, H Oxedrine is a mandatory component of Citrus sinensis when intended for internal use. The quantity of Oxedrine in the recommended daily dose must be no more than 30 mg. 1467 CITRUS SINENSIS PEEL MOLASSES EXTRACT E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1468 CITRUS UNSHIU A, E, H Oxedrine is a mandatory component of Citrus unshiu when intended for internal use. The quantity of Oxedrine in the recommended daily dose must be no more than 30 mg. 1469 CITRUS X PARADISI A, E, H 1470 CITRUS X WILSONII A, H 1471 CIVET E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1472 CIVET ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1473 CIVET SYNTHETIC E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1474 CIVETONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1475 CLARY OIL A, E, H 1476 CLEMATIS ARMANDII A, H 1477 CLEMATIS CHINENSIS A, E, H 1478 CLEMATIS RECTA A, H 1479 CLEMATIS VITALBA A, H 1480 CLERODENDRUM TRICHOTOMUM A, H 1481 CLINOPODION POLYCEPHALUM A, H 1482 CLINOPODIUM NEPETA SUBSP. GLANDULOSUM A, H 1483 CLIVER HERB DRY A, H 1484 CLIVER HERB POWDER A, H 1485 CLOVE BUD OIL A, E, H When the total concentration of clove oils (including clove bud oil, clove leaf oil, and clove stem oil) in the medicine is more than 25%: (a) the nominal capacity of the container must not be more than 25 mL; (b) a restricted flow insert must be fitted on the container; (c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect) - (NTAKEN) 'Not to be taken'; and (d) When the nominal capacity of the container is more than 15 mL, a child resistant closure must also be fitted on the container. 1486 CLOVE DRY A, E, H 1487 CLOVE LEAF OIL A, E, H When the total concentration of clove oils (including clove bud oil, clove leaf oil, and clove stem oil) in the medicine is more than 25%: (a) the nominal capacity of the container must not be more than 25 mL; (b) a restricted flow insert must be fitted on the container; (c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect) - (NTAKEN) 'Not to be taken'; and (d) When the nominal capacity of the container is more than 15 mL, a child resistant closure must also be fitted on the container. 1488 CLOVE OIL TERPENES E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1489 CLOVE POWDER A, E, H 1490 CLOVE STEM OIL A, E, H When the total concentration of clove oils (including clove bud oil, clove leaf oil, and clove stem oil) in the medicine is more than 25%: (a) the nominal capacity of the container must not be more than 25 mL; (b) a restricted flow insert must be fitted on the container; (c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect) - (NTAKEN) 'Not to be taken'; and (d) When the nominal capacity of the container is more than 15 mL, a child resistant closure must also be fitted on the container. 1491 CLUPEA HARENGUS LIPID EXTRACT A Only for use in oral medicines. The maximum recommended daily dose must not provide more than 2750 mg EPA, DHA and DPA combined, when used alone or in combination with other sources of omega-3 fatty acids. 1492 CNICUS BENEDICTUS A, H 1493 CNICUS JAPONICUS A, H 1494 CNIDIUM MONNIERI A, H 1495 CNIDIUM OFFICINALE A, H 1496 COBALTOUS NITRATE HEXAHYDRATE H Only for use as an active homoeopathic ingredient. 1497 COCAMIDE DEA E Only for use in topical medicines for dermal application. 1498 COCAMIDE MEA E Only for use in topical medicines for dermal application. 1499 COCAMIDOPROPYL BETAINAMIDE MEA CHLORIDE E Only for use in topical medicines for dermal application and not to be included in topical products intended for use in the eye. The concentration in the medicine must be no more than 1%. 1500 COCAMIDOPROPYL BETAINE E Only for topical, mucous membrane (buccal mucosa) and dental use and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be: a) no more than 1% in leave on medicines b) no more than 15% in wash on /wash off medicines c) 1.2% for buccal mucosa and dental medicines. Levels of impurities 3-dimethylaminopropylamine (DMAPA) and amidoamine (dimethylaminopropylcocoamide; AA) must be controlled to below the level of detection. 1501 COCCOLOBIA UVIFERA A, H 1502 COCCULUS ORBICULATUS A, H 1503 COCHINEAL E, H Only for use as an active homoeopathic ingredient or for excipient use only as a colour in oral and topical medicines. 1504 COCHLEARIA OFFICINALIS A, H 1505 COCILLANA DRY A, H 1506 COCILLANA POWDER A, H 1507 COCO-BETAINE E Only for use in topical medicines for dermal application. 1508 COCO-CAPRYLATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration is to be no more than 12.5% in the medicine. 1509 COCO-GLUCOSIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.025% 1510 COCO-OCTANOATE/DECANOATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. 1511 COCOA EXTRACT E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1512 COCOA POWDER A, E, H 1513 COCOGLYCERIDES E 1514 COCONUT E 1515 COCONUT ACID E Only for use in topical medicines for dermal application. 1516 COCONUT OIL A, E, H 1517 COCOS NUCIFERA A, E, H 1518 COD-LIVER OIL A, E Vitamin A and colecalciferol are mandatory components of Cod-liver oil. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) 'WARNING: If you are pregnant - or considering becoming pregnant - do not take vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].' NOTE: Position this warning at the beginning of the directions for use. - (VITA4) 'WARNING - When taken in excess of 3000 micrograms retinol equivalents - vitamin A can cause birth defects.' NOTE: Position this warning at the beginning of the directions for use. - (VITA3) 'The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.' When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of vitamin D. 1519 CODONOPSIS LANCEOLATA A, H 1520 CODONOPSIS PILOSULA A, H 1521 CODONOPSIS TANGSHEN A, H 1522 COFFEA ARABICA A, E, H Caffeine is a mandatory component of Coffea arabica. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: - (ADULT) 'Adults only' (or words to that effect). - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80 mg of caffeine.' - (CAFFPREG) 'Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.' When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.' - (CAFFCYP) 'Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines' (or words to that effect). 1523 COFFEA CANEPHORA A, E, H Caffeine is a mandatory component of Coffea canephora. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: - (ADULT) 'Adults only' (or words to that effect). - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80 mg of caffeine.' - (CAFFPREG) 'Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.' When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.' - (CAFFCYP) 'Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines' (or words to that effect). 1524 COFFEE E, H Caffeine is a mandatory component of coffee. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: - (ADULT) 'Adults only' (or words to that effect). - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.' - (CAFFPREG) 'Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.' When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.' - (CAFFCYP) 'Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines' (or words to that effect). 1525 COFFEE OIL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1526 COFFEE SOLID EXTRACT E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1527 COGNAC OIL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1528 COGNAC OIL GREEN A, E, H 1529 COGNAC OIL WHITE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1530 COIX LACHRYMA-JOBI A, H 1531 COLA ACUMINATA A, E, H Caffeine is a mandatory component of Cola acuminata. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: - (ADULT) 'Adults only' (or words to that effect). - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.' - (CAFFPREG) 'Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.' When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.' - (CAFFCYP) 'Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines' (or words to that effect). 1532 COLA NITIDA A, E, H Caffeine is a mandatory component of Cola nitida. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: - (ADULT) 'Adults only' (or words to that effect). - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.' - (CAFFPREG) 'Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.' When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.' - (CAFFCYP) 'Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines' (or words to that effect). 1533 COLCHICUM AUTUMNALE H Only for use as an active homoeopathic ingredient. The total concentration of Colchicum autumnale in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 1534 COLECALCIFEROL A, E When for internal use, the maximum recommended daily dose must not be more than 25 micrograms of Vitamin D. 1535 COLLAGEN E 1536 COLLINSONIA CANADENSIS A, H 1537 COLLOIDAL ANHYDROUS SILICA A, E, H Only for use when the route of administration is other than inhalation. 1538 COLOPHONY A, E, H 1539 COMMIPHORA HABESSINICA A, H 1540 COMMIPHORA KATAF A, H 1541 COMMIPHORA MYRRHA A, E, H 1542 COMMON INDIAN COBRA H Only for use as an active homoeopathic ingredient. 1543 CONCENTRATED FISH OMEGA-3 TRIGLYCERIDES A Only for oral use. 1544 CONCENTRATED SQUID OMEGA-3 TRIGLYCERIDES A Only for oral use. 'Concentrated squid omega-3-triglycerides' must be obtained from species of the order Teuthida of the class Cephalopoda AND be in combination with other ingredients in the preparation AND be presented in a therapeutic dosage form for therapeutic use. The following warning statement is required on the medicine label: - (MOLLUSC) 'Contains mollusc' or 'Contains mollusc products'. 1545 CONIFER GREEN NEEDLE COMPLEX A Only for topical and oral use. Must be made by petroleum ether extraction of needles of the conifer species Pinus sylvestris (Scotch Pine) and Picea abies (Norwegian Spruce). 1546 CONIFER PHYTOSTEROL COMPLEX A 1547 CONIOSELINUM TATARICUM A, H 1548 CONIUM MACULATUM H Only for use as an active homoeopathic ingredient. The homoeopathic potency of Conium maculatum in the final medicine must be 12X or greater. 1549 CONVALLARIA MAJALIS A, H The concentration of equivalent dry Convallaria majalis in the product must be no more than 10mg/Kg or 10mg/L or 0.001%. 1550 CONYZA CANADENSIS A, H 1551 COPAIBA OIL A, E, H 1552 COPAIFERA LANGSDORFFII A, E, H 1553 COPERNICIA CERIFERA A, E, H 1554 COPOVIDONE E 1555 COPPER H Only for use as an active homoeopathic ingredient. When for internal use the maximum daily dose must not contain more than 5 mg of copper. When for other than internal use, the concentration of copper compounds must be no more than 5%. 1556 COPPER (II) ASPARTATE A, H Copper is a mandatory component of copper (II) aspartate. The percentage of copper from copper (II) aspartate should be calculated based on the molecular weight of copper (II) aspartate. The concentration of copper compounds in products must be no more than 5%. The maximum daily dose must not contain more than 5mg of copper. 1557 COPPER (II) GLYCINATE A, H Copper is a mandatory component of copper (II) glycinate. The percentage of copper from copper (II) glycinate should be calculated based on the molecular weight of Copper (II) glycinate. The concentration of copper compounds in products must be no more than 5%. The maximum daily dose must not contain more than 5mg of copper. 1558 COPPER (II) LYSINATE A, H Copper is a mandatory component of copper (II) lysinate. The percentage of copper from copper (II) lysinate should be calculated based on the molecular weight of Copper (II) lysinate. The concentration of copper compounds in products must be no more than 5%. The maximum daily dose must not contain more than 5mg of copper. 1559 COPPER ACETYL TYROSINATE METHYLSILANOL E Only for use in topical medicines for dermal application. 1560 COPPER CHLOROPHYLL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1561 COPPER CHLOROPHYLLIN E Only for use as a colour in oral and topical medicines. 1562 COPPER GLUCONATE A, E Copper is a mandatory component of copper gluconate. The percentage of copper from copper gluconate should be calculated based on the molecular weight of copper gluconate. When for internal use the maximum daily dose must not contain more than 5 mg of copper. When for other than internal use, the concentration of copper compounds must be no more than 5%. 1563 COPPER TRIPEPTIDE-1 E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 3%. 1564 COPTIS CHINENSIS A, H 1565 COPTIS JAPONICA A, H 1566 CORALLINA OFFICINALIS E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine is to be no more than 1%. 1567 CORDYCEPS SINENSIS A, E, H Must not contain material of animal origin such as insect larvae. 1568 CORIANDER DRY A, H 1569 CORIANDER OIL A, E, H 1570 CORIANDER POWDER A, H 1571 CORIANDRUM SATIVUM A, E, H 1572 CORMUS DOMESTICA A, H 1573 CORN GLYCERIDES E 1574 CORN SILK DRY A, H 1575 CORN SILK POWDER A, H 1576 CORN SYRUP E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1577 CORN SYRUP SOLIDS E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1578 CORNUS FLORIDA A, H 1579 CORNUS OFFICINALIS A, H 1580 CORTISONE ACETATE H Only available as an active homoeopathic ingredient. 1581 CORYDALIS AMBIGUA A, E, H 1582 CORYDALIS BUNGEANA A, H 1583 CORYDALIS CAVA A, H 1584 CORYDALIS FABACEA A, H 1585 CORYDALIS FORMOSA A, H 1586 CORYDALIS TURTSCHANINOVII A, H 1587 CORYLUS AMERICANA A, H 1588 CORYLUS AVELLANA A, H 1589 CORYMBIA CITRIODORA A, E, H Cineole is a mandatory component of Corymbia citriodora. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 1590 CORYMBIA FICIFOLIA A, H Cineole is a mandatory component of Corymbia ficifolia. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 1591 COSMOS BIPINNATUS A, H 1592 COSTUS ROOT OIL A, H 1593 COSTUS SPICATUS A, H 1594 COTTONSEED OIL A, E, H 1595 COUCH GRASS RHIZOME DRY A, H 1596 COUCH GRASS RHIZOME POWDER A, H 1597 COUMARIN E, H Only for use as an active homoeopathic ingredient or excipient ingredient. The concentration of coumarin in the medicine must not be more than 0.001%. When used as an excipient: (a) must only be used in topical medicines for dermal application; and (b) the label of the medicine must specify that the product should only be used by adults. 1598 CRANBERRY E 1599 CRATAEGUS CUNEATA A, E, H 1600 CRATAEGUS GERMANICA A, H 1601 CRATAEGUS LAEVIGATA A, E, H 1602 CRATAEGUS MONOGYNA A, E, H 1603 CRATAEGUS PINNATIFIDA A, E, H 1604 CRATEVA MAGNA A, E, H 1605 CREATINE A, E 1606 CREATINE MONOHYDRATE A, E 1607 CREATINE PHOSPHATE A, E 1608 CREATININE E Only for use in topical medicines for dermal application and not for use in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. 1609 CREOSOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1610 CREOSOTE H Only for use as an active homoeopathic ingredient. Creosote must not be derived from coal or beechwood. 1611 CRESOL E Only for use as a preservative in topical medicines. The concentration of phenols (including cresols and xylenols and any other homologue of phenol) boiling below 220 degrees centigrade must be no more than 3%. 1612 CRITHMUM MARITIMUM WHOLE PLANT EXTRACT E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.00341%. 1613 CROCUS SATIVUS A, E, H When Crocus sativus is used as an excipient: (a) the ingredient must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation; (b) the plant part must be stigma and/or style; (c) the plant preparation must be fresh or dry; and (d) the total concentration of flavour proprietary excipient formulations containing the ingredient must not be more than 5% of the total medicine. 1614 CROSCARMELLOSE SODIUM E 1615 CROSPOVIDONE E 1616 CROTON CASCARILLA A, H The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material. 1617 CROTON ELUTERIA A, H The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material. 1618 CRYPTOMERIA JAPONICA A, H 1619 CUBEB OIL A, H 1620 CUBEBENE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1621 CUCUMBER E 1622 CUCUMIS MELO A, H 1623 CUCUMIS SATIVUS A, E, H 1624 CUCURBITA MAXIMA A, E, H 1625 CUCURBITA MOSCHATA A, H 1626 CUCURBITA PEPO A, E, H 1627 CULLEN CORYLIFOLIUM A, H 1628 CUMIC ALCOHOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1629 CUMIN OIL A, E, H 1630 CUMINALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1631 CUMINUM CYMINUM A, H 1632 CUMINYL NITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1633 CUPRESSUS ARIZONICA A, H 1634 CUPRESSUS FUNEBRIS A, E, H 1635 CUPRESSUS SEMPERVIRENS A, E, H 1636 CUPRIC ACETATE MONOHYDRATE H Only for use as an active homoeopathic ingredient. 1637 CUPRIC ARSENITE H Only for use as an active homoeopathic ingredient. 1638 CUPRIC CITRATE A, E, H When for oral or sublingual use, copper is a mandatory component of cupric citrate. The percentage of copper from cupric citrate should be calculated based on the molecular weight of cupric citrate. The medicine must not contain more than 750 micrograms of copper from cupric citrate per the recommended daily dose or the medicine must not contain more than 1.86 milligrams of cupric citrate per the recommended daily dose. 1639 CUPRIC CITRATE HEMIPENTAHYDRATE A, E, H When for oral or sublingual use, copper is a mandatory component of cupric citrate hemipentahydrate. The percentage of copper from cupric citrate hemipenthydrate should be calculated based on the molecular weight of cupric citrate hemipenthydrate. The medicine must not contain more than 750 micrograms of copper from cupric citrate hemipentahydrate per the recommended daily dose OR the medicine must not contain more than 2.13 milligrams of cupric citrate hemipentahydrate per the recommended daily dose. 1640 CUPRIC OXIDE A, E, H When for oral or sublingual use, copper is a mandatory component of cupric oxide. The percentage of copper from cupric oxide should be calculated based on the molecular weight of cupric oxide. When for internal use the maximum daily dose must not contain more than 5 mg of copper. When for other than internal use, the concentration of copper compounds must be no more than 5%. 1641 CUPRIC SULFATE A, E, H When for oral or sublingual use, copper is a mandatory component of cupric sulfate. The percentage of copper from cupric sulfate should be calculated based on the molecular weight of cupric sulfate. When for internal use the maximum daily dose must not contain more than 5 mg of copper. When for other than internal use, the concentration of copper compounds must be no more than 5%. 1642 CUPRIC SULFATE MONOHYDRATE A, E, H When for oral or sublingual use, copper is a mandatory component of cupric sulfate monohydrate. The percentage of copper from cupric sulfate monohydrate should be calculated based on the molecular weight of cupric sulfate monohydrate. When for internal use the maximum daily dose must not contain more than 5 mg of copper. When for other than internal use, the concentration of copper compounds must be no more than 5%. When used topically, cupric sulfate is a mandatory component of cupric sulfate monohydrate. 1643 CUPRIC SULFATE PENTAHYDRATE A, E, H When for oral or sublingual use, copper is a mandatory component of cupric sulfate pentahydrate. The percentage of copper from cupric sulfate pentahydrate should be calculated based on the molecular weight of cupric sulfate pentahydrate. When for internal use the maximum daily dose must not contain more than 5 mg of copper. When for other than internal use, the concentration of copper compounds must be no more than 5%. When used topically cupric sulfate is a mandatory component of cupric sulfate pentahydrate. The percentage of cupric sulfate from cupric sulfate pentahydrate should be calculated based on the molecular weight of cupric sulfate pentahydrate. 1644 CURCULIGO ORCHIOIDES A, H 1645 CURCUMA AROMATICA A, H When used in oral medicines as an active ingredient, the following warning statement is required on the medicine label: 'In very rare cases, Curcuma species may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.' When used in oral medicines the maximum daily dose of (1E,6E)-1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione in the medicine must not provide more than: (a) 36 mg for children from 2-3 years (inclusive); (b) 48 mg for children from 4-11 years (inclusive); and (c) 123 mg for children from 12-17 years (inclusive). Not permitted for use in children aged below 2 years. 1646 CURCUMA LONGA A, E, H When used in oral medicines as an active ingredient, the following warning statement is required on the medicine label: 'In very rare cases, Curcuma species may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.' When used in oral medicines the maximum daily dose of (1E,6E)-1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione in the medicine must not provide more than: (a) 36 mg for children from 2-3 years (inclusive); (b) 48 mg for children from 4-11 years (inclusive); and (c) 123 mg for children from 12-17 years (inclusive). Not permitted for use in children aged below 2 years. 1647 CURCUMA ZANTHORRHIZA A, H When used in oral medicines as an active ingredient, the following warning statement is required on the medicine label: 'In very rare cases, Curcuma species may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.' When used in oral medicines the maximum daily dose of (1E,6E)-1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione in the medicine must not provide more than: (a) 36 mg for children from 2-3 years (inclusive); (b) 48 mg for children from 4-11 years (inclusive); and (c) 123 mg for children from 12-17 years (inclusive). Not permitted for use in children aged below 2 years. 1648 CURCUMA ZEDOARIA A, H When used in oral medicines as an active ingredient, the following warning statement is required on the medicine label: 'In very rare cases, Curcuma species may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.' When used in oral medicines the maximum daily dose of (1E,6E)-1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione in the medicine must not provide more than: (a) 36 mg for children from 2-3 years (inclusive); (b) 48 mg for children from 4-11 years (inclusive); and (c) 123 mg for children from 12-17 years (inclusive). Not permitted for use in children aged below 2 years. 1649 CURCUMIN A, E, H When for excipient use, only permitted for use as a colour in topical and oral medicines. When used in oral medicines as an active ingredient, the following warning statement is required on the medicine label: 'In very rare cases, curcumin may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.' When used in oral medicines the maximum daily dose of (1E,6E)-1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione in the medicine must not provide more than: (a) 36 mg for children from 2-3 years (inclusive); (b) 48 mg for children from 4-11 years (inclusive); and (c) 123 mg for children from 12-17 years (inclusive). Not permitted for use in children aged below 2 years. 1650 CUSCUTA EPITHYMUM A, H 1651 CUSCUTA EUROPAEA A, H 1652 CUSCUTA HYGROPHILAE A, H 1653 CUSCUTA RACEMOSA A, H 1654 CUSPARIA FEBRIFUGA A, H 1655 CYAMOPSIS TETRAGONOLOBA A, E, H 1656 CYANOCOBALAMIN A, E, H 1657 CYANOMETHYLPHENYL MENTHANE CARBOXAMIDE E For dental use only in proprietary ingredients. Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in the medicine must be no more than 5%. 1658 CYATHULA OFFICINALIS A, H 1659 CYCLAMEN ALDEHYDE E Only for use as an excipient ingredient in topical medicines. 1660 CYCLAMEN PURPURASCENS A, H 1661 CYCLOCARYA PALIURUS LEAF EXTRACT DRY A Only to be used in a medicine where Infinitus (China) Company Ltd (Client ID 81208), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 25 October 2025. The route of administration for medicines that contain Cyclocarya paliurus leaf extract dry must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 2 g of Cyclocarya paliurus leaf extract dry. The recommend duration of use for a medicine containing Cyclocarya paliurus leaf extract dry must be limited to 12 weeks or less. The following warning statements (or words to the same effect) are required on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women'; and - (ADULT) 'Adults only'. 1662 CYCLOHEXADECENONE-8 E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1663 CYCLOHEXANE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1664 CYCLOHEXANE, 1-ETHENYL-1-METHYL-2-(1-METHYLETHENYL)-4-(1-METHYLETHYL)-, DIDEHYDRO DERIV. E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1665 CYCLOHEXANEETHANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1666 CYCLOHEXYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1667 CYCLOHEXYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 1668 CYCLOHEXYL PHENETHYL ETHER E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1669 CYCLOHEXYL SALICYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1670 CYCLOHEXYLETHYL ACETATE E Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 1671 CYCLOMETHICONE E Only for use as an excipient ingredient in topical medicines. 1672 CYCLOPENTADECANONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1673 CYDONIA OBLONGA A, H 1674 CYMBOPOGON FLEXUOSUS A, E, H When for topical use, aldehydes calculated as citral is a mandatory component of Cymbopogon flexuosus and the concentration of aldehydes calculated as citral in the medicine must not be more than 5%. 1675 CYMBOPOGON MARTINI A, H When for topical use, aldehydes calculated as citral is a mandatory component of Cymbopogon martini and the concentration of aldehydes calculated as citral in the medicine must be no more than 5%. 1676 CYMBOPOGON NARDUS A, H When for topical use, aldehydes calculated as citral is a mandatory component of Cymbopogon nardus and the concentration of aldehydes calculated as citral in the medicine must be no more than 5%. 1677 CYMBOPOGON SCHOENANTHUS A, E, H When for topical use, aldehydes calculated as citral is a mandatory component of Cymbopogon schoenanthus and the concentration of aldehydes calculated as citral in the medicine must be no more than 5%. 1678 CYNANCHUM ATRATUM A, H 1679 CYNANCHUM STAUNTONII A, E, H 1680 CYNARA SCOLYMUS A, E, H 1681 CYNODON DACTYLON A, E, H 1682 CYNOMORIUM COCCINEUM SUBSP. SONGARICUM A, H 1683 CYPERUS LONGUS A, H 1684 CYPERUS ROTUNDUS A, H 1685 CYPRESS OIL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1686 CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS A, H 1687 CYSTEINE A The maximum recommended daily dose must not contain more than 450 mg of cysteine. When cysteine, cystine and/or their salts are used in combination, the medicine must not provide more than a total of 450 mg cysteine per maximum recommended daily dose. 1688 CYSTEINE HYDROCHLORIDE A The maximum recommended daily dose must contain no more than 585 mg of cysteine hydrochloride. When cysteine, cystine and/or their salts are used in combination, the medicine must not provide more than a total of 450 mg cysteine per maximum recommended daily dose. 1689 CYSTEINE HYDROCHLORIDE MONOHYDRATE A, E When used as an excipient, permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient and the total flavour proprietary excipient formulation concentration in a medicine must not be more than 5%. The maximum recommended daily dose must contain no more than 652 mg of cysteine hydrochloride monohydrate. When cysteine, cystine and/or their salts are used in combination, the medicine must not provide more than a total of 450 mg cysteine per maximum recommended daily dose. 1690 CYSTINE A The maximum recommended daily dose must contain no more than 450 mg of cystine. When cysteine, cystine and/or their salts are used in combination, the medicine must not provide more than a total of 450 mg cysteine per maximum recommended daily dose. 1691 CYTISUS SCOPARIUS A, H Sparteine is a mandatory component of Cytisus scoparius. The concentration of Sparteine in the medicine must be no more than 0.001%. 1692 D-ALPHA-TOCOPHEROL A, E 1693 D-ALPHA-TOCOPHERYL ACETATE A, E, H 1694 D-ALPHA-TOCOPHERYL ACID SUCCINATE A, E 1695 D-ALPHA-TOCOPHERYL PHOSPHATES E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 3%. 1696 D-BORNEOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1697 D-CARVONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1698 D-FENCHONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1699 D-GLUCOSE, POLYMER WITH XYLITOL E The route of administration for medicines that contain D-glucose, polymer with xylitol must be limited to topical for dermal use. The total concentration of D-glucose, polymer with xylitol in the medicine must not be more than 5%. The following warning statements (or words to the same effect) are required on the medicine label: - (EYE) 'Avoid contact with eyes'; and - (BROKEN) 'Use on unbroken skin only'. 1700 D-LIMONENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1701 D-PULEGONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. The concentration of d-pulegone in the medicine must not be more than 4%. 1702 D-RIBOSE-L-CYSTEINE A Only for use in oral medicines. Cysteine is a mandatory component of D-Ribose-L-Cysteine. The medicine must provide no more than 450 mg of cysteine per maximum recommended daily dose. 1703 DACTYLIS GLOMERATA A, H 1704 DACTYLORHIZA INCARNATA SUBSP. INCARNATA A, H 1705 DAEMONOROPS DRACO A, E, H 1706 DAHLIA PINNATA A, H 1707 DALBERGIA ODORIFERA A, H 1708 DAMIANA LEAF POWDER A 1709 DANDELION LEAF DRY A, H 1710 DANDELION LEAF POWDER A, H 1711 DANDELION ROOT DRY A, H 1712 DANDELION ROOT POWDER A, H 1713 DAPHNE GENKWA A, H 1714 DAPHNE MEZEREUM A, H The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material. 1715 DATURA STRAMONIUM A, H Only for use in oral medicines. Alkaloids calculated as hyoscyamine is a mandatory component of Datura stramonium. The concentration of alkaloids calculated as hyoscyamine from all ingredients in the product must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. 1716 DAUCUS CAROTA A, E, H 1717 DAVANA OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1718 DEA-OLETH-3 PHOSPHATE E Only for use in topical medicines for dermal application and not be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. The medicine requires the following warning statements on the medicine label: - (EYE) 'Avoid contact with eyes' - (EYE2) 'May be irritant to the eyes' (or words to that effect). 1719 DECAHYDRO-1,1,7-TRIMETHYL-3A,7-METHANO-3AH-CYCLOPENTACYCLOOCT-3-YL FORMATE E Decahydro-1,1,7-trimethyl-3a,7-methano-3ah-cyclopentacyclooct-3-yl formate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing decahydro-1,1,7-trimethyl-3a,7-methano-3ah-cyclopentacyclooct-3-yl formate must not be more than 1% of the total medicine. 1720 DECAHYDRO-2,2,6,6,7,8,8-HEPTAMETHYL-2H-INDENO(4,5-B) FURAN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1721 DECAHYDRO-BETA-NAPHTHYLACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1722 DECAHYDRO-BETA-NAPHTHYLFORMATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1723 DECAHYDROSPIRO(FURAN-2(3H),5'-(4,7)METHANO(5H)INDENE) E Permitted for use only in combination with other permitted ingredients as a fragrance. The total fragrance concentration in a medicine must be no more than 1%. 1724 DECALACTONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1725 DECANAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1726 DECANAL DIMETHYL ACETAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1727 DECARBOXY CARNOISINE DIHYDROCHLORIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.05. 1728 DECENAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1729 DECYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1730 DECYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1731 DECYL GLUCOSIDE E Only for use in topical medicines for dermal application. 1732 DECYL OLEATE E Only for use in topical medicines for dermal application. 1733 DECYLENE GLYCOL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.5%. 1734 DEER ANTLER CARTILAGE H Only for use as an active homoeopathic ingredient. 1735 DEER VELVET ANTLER POWDER A Medicines that contain 'deer velvet antler powder' as the therapeutically active ingredient are subject to the following conditions: a) the medicines are for oral use only; b) the antlers (including the velvet) are sourced only from red deer (Cervus elaphus), elk/wapiti (Cervus canadensis), or a crossbreed of these species; c) the deer are sourced only from farmed stock bred and raised in New Zealand; d) the deer are sourced only from herds farmed for food in accordance with the Animal Products Act 1999 (New Zealand) and the regulations made under that Act, as in force or existing from time to time; e) the antlers are removed from the deer only according to the Animal Welfare Act 1999 (New Zealand) and the regulations made under that Act, as in force or existing from time to time. 1736 DEER VELVET ANTLER SLICE A Medicines that contain 'deer velvet antler slice' as the therapeutically active ingredient are subject to the following conditions: a) the medicines are for oral use only; b) the antlers (including the velvet) are sourced only from red deer (Cervus elaphus), elk/wapiti (Cervus canadensis), or a crossbreed of these species; c) the deer are sourced only from farmed stock bred and raised in New Zealand; d) the deer are sourced only from herds farmed for food in accordance with the Animal Products Act 1999 (New Zealand) and the regulations made under that Act, as in force or existing from time to time; e) the antlers are removed from the deer only according to the Animal Welfare Act 1999 (New Zealand) and the regulations made under that Act, as in force or existing from time to time. 1737 DEERTONGUE ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1738 DEHYDROACETIC ACID E Only for use in topical medicines for dermal application. 1739 DEHYDROMENTHOFUROLACTONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1740 DEHYDROXANTHAN GUM E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 1741 DELPHINIUM STAPHISAGRIA A, H The concentration of the equivalent dry Delphinium staphisagria in the medicine must be no more than 0.2%. 1742 DELTA-DAMASCONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1743 DELTA-DECALACTONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1744 DELTA-DODECALACTONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1745 DELTA-NONALACTONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1746 DELTA-OCTALACTONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1747 DELTA-TETRADECALACTONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1748 DELTA-TOCOPHEROL E 1749 DELTA-UNDECALACTONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1750 DEMINERALISED FISH PROTEOGLYCAN EXTRACT A 1751 DENATONIUM BENZOATE E 1752 DENDROBIUM NOBILE A, H 1753 DESCURAINIA SOPHIA A, H 1754 DESMODIUM STYRACIFOLIUM A, H 1755 DEVIL'S CLAW TUBER DRY A, H 1756 DEVIL'S CLAW TUBER POWDER A, H 1757 DEXPANTHENOL A, E 1758 DEXTRAN 20 E Only for use in topical medicines for dermal application and not be included in topical medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.3%. 1759 DEXTRAN 40 A, E 1760 DEXTRATES E 1761 DEXTRIN E 1762 DEXTRIN PALMITATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. 1763 DHA/EPA RICH SCHIZOCHYTRIUM ALGAL OIL A Docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are mandatory components of DHA/EPA rich schizochytrium algal oil. Only for use in oral medicines when in combination with other active or excipient ingredients. The ratio of DHA to EPA must be 2:1. 1764 DI-C12-13 ALKYL MALATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 1765 DI-C12-15 ALKYL FUMARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 1766 DI-N-PROPYL ISOCINCHOMERONATE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 25%. 1767 DI-PPG-3 MYRISTYL ETHER ADIPATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 15%. 1768 DIACETIN E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1769 DIACETYL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1770 DIACETYL TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1771 DIACETYLATED MONOGLYCERIDES E Permitted for use only in combination with other permitted ingredients as a coating solution. 1772 DIAMMONIUM LAURYL SULFOSUCCINATE E Only for use as an excipient ingredient in topical medicines. 1773 DIANTHUS SUPERBUS A, H 1774 DIAZOLIDINYL UREA E Only for use in topical medicines for dermal application. 1775 DIBASIC MAGNESIUM CITRATE TETRAHYDRATE A Only for use in oral medicines. 1776 DIBASIC MAGNESIUM PHOSPHATE TRIHYDRATE A, E, H Magnesium is a mandatory component of dibasic magnesium phosphate trihydrate. The percentage of magnesium from dibasic magnesium phosphate trihydrate should be calculated based on the molecular weight of dibasic magnesium phosphate trihydrate. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 1777 DIBASIC POTASSIUM PHOSPHATE A, E, H When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of dibasic potassium phosphate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 1778 DIBASIC POTASSIUM PHOSPHATE TRIHYDRATE A, E, H When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of dibasic potassium phosphate trihydrate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 1779 DIBASIC SODIUM PHOSPHATE A, E, H When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 1780 DIBASIC SODIUM PHOSPHATE DIHYDRATE A, E, H When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate dihydrate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 1781 DIBASIC SODIUM PHOSPHATE DODECAHYDRATE A, E, H When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate dodecahydrate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 1782 DIBASIC SODIUM PHOSPHATE HEPTAHYDRATE A, E, H When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate heptahydrate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 1783 DIBASIC SODIUM PHOSPHATE MONOHYDRATE A, E, H When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate monohydrate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 1784 DIBENZYL KETONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1785 DIBUTYL ADIPATE E Only for use in topical medicines for dermal application. 1786 DIBUTYL SEBACATE E 1787 DIBUTYLAMINE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in the medicine must be no more than 5%. 1788 DICAPRYLYL CARBONATE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 34%. 1789 DICAPRYLYL ETHER E Only for use in topical medicines for dermal application. 1790 DICAPRYLYL MALEATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. 1791 DICETYL PHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. 1792 DICHLOROBENZYL ALCOHOL E 1793 DICHLOROMETHANE E The concentration in the medicine must be no more than 0.06%. The residual solvent limit for Dichloromethane is 6 mg per recommended daily dose. 1794 DICTAMNUS ALBUS A, H 1795 DICTAMNUS DASYCARPUS A, H 1796 DICYCLOHEXYL DISULFIDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1797 DIEFFENBACHIA SEGUINE H Only for use as an active homoeopathic ingredient. 1798 DIETHANOLAMINE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%. 1799 DIETHYL CITRACONATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1800 DIETHYL HYDROGEN 2-HYDROXYPROPANE-1,2,3-TRICARBOXYLATE E Diethyl hydrogen 2-hydroxypropane-1,2,3-tricarboxylate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing diethyl hydrogen 2-hydroxypropane-1,2,3-tricarboxylate must not be more than 1% of the total medicine. 1801 DIETHYL MALONATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1802 DIETHYL PHTHALATE E 1803 DIETHYLAMINE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1804 DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 1805 DIETHYLAMINOMETHYLCOUMARIN E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%. 1806 DIETHYLDIMETHYL-2-CYCLOHEXENONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1807 DIETHYLENE GLYCOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1808 DIETHYLENE GLYCOL MONOETHYL ETHER E Only for use in topical medicines for dermal application. 1809 DIETHYLHEXYL CARBONATE E Only for use in topical medicines for dermal application and not be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 3%. 1810 DIETHYLHEXYL SEBACATE E Only for use in topical medicines for dermal application. 1811 DIETHYLHEXYL SYRINGYLIDENEMALONATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 1812 DIETHYLHEXYL-2,6-NAPHTHALATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. The medicine requires the following warning statement on the medicine label: - (EYE2) 'May be irritant to the eyes' (or words to that effect). 1813 DIETHYLTOLUAMIDE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 20%. The medicine requires the following warning statement on the medicine label: - (DEET) 'WARNING: May be dangerous; particularly to children, if you use large amounts on the skin, clothes or bedding or on large areas of the body, especially if you keep using it for a long time.' 1814 DIGITALIS LEAF DRY A, H The concentration of Digitalis leaf dry in the product must be no more than 10mg/Kg or 10mg/L or 0.001%. 1815 DIGITALIS LEAF POWDER A, H The concentration of Digitalis leaf powder in the product must be no more than 10mg/Kg or 10mg/L or 0.001%. 1816 DIGITALIS PURPUREA A, H The concentration of equivalent dry Digitalis purpurea in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%. 1817 DIGLYCOL/CHDM/ISOPHTHALATES/SIP COPOLYMER E Only for use in topical medicines for dermal application. 1818 DIHEXYL FUMARATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1819 DIHYDRO JASMONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1820 DIHYDRO TERPINYLACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1821 DIHYDRO-ALPHA-TERPINEOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1822 DIHYDRO-BETA-IONONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1823 DIHYDRO-ISOJASMONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1824 DIHYDROACTINIDIOLIDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1825 DIHYDROAMBRETTOLIDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1826 DIHYDROCAPSIATE A The route of administration for medicines that contain dihydrocapsiate must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 9 mg dihydrocapsiate. The following warning statements (or words to the same effect) are required on the medicine label: - (ADULT) 'Adults only'; and - (PREGNT) 'Not recommended for use by pregnant and lactating women'. 1827 DIHYDROCARVYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1828 DIHYDROCOUMARIN E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1829 DIHYDROCUMINYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 1830 DIHYDROEUGENOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1831 DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 1832 DIHYDROINDENYL-2,4-DIOXANE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1833 DIHYDROLINALOOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1834 DIHYDROMYRCENOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1835 DIHYDROMYRCENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1836 DIHYDROXYACETONE E Only for use in topical medicines for dermal application. 1837 DIISOPROPYL ADIPATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 15%. 1838 DIISOPROPYL SEBACATE E Only for use in topical medicines for dermal application and not be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. 1839 DIISOSTEARYL DIMER DILINOLEATE E Only for use in topical medicines for dermal application. 1840 DILAURYL THIODIPROPIONATE E Only for use in topical medicines for dermal application. 1841 DILL HERB OIL A, E, H 1842 DILL SEED OIL A, E, H 1843 DIMER DISTEARYLTRICARBONATE E Only for use in topical medicines for dermal application and not to be used in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. 1844 DIMETHICONE 12500 E 1845 DIMETHICONE 4000 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. 1846 DIMETHICONE CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 15%. 1847 DIMETHICONE SILYLATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. 1848 DIMETHICONE/METHICONE COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. 1849 DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%. 1850 DIMETHYL 3-CYCLOHEXENE-1-CARBOXALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1851 DIMETHYL ANTHRANILATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1852 DIMETHYL BENZYL CARBINOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1853 DIMETHYL BENZYL CARBINYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1854 DIMETHYL BENZYL CARBINYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1855 DIMETHYL BENZYL CARBINYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1856 DIMETHYL PHENYLETHYL CARBINOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1857 DIMETHYL PHTHALATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1858 DIMETHYL POLYSILOXANE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1859 DIMETHYL SUCCINATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1860 DIMETHYL SULFIDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1861 DIMETHYL SULFONE A Only for use in oral and topical medicines. 1862 DIMETHYL SULFOXIDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1863 DIMETHYLACETAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1864 DIMETHYLCYCLOHEXYLETHOXY ISOBUTYLPROPANOATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1865 DIMETHYLGLYCINE HYDROCHLORIDE A Only for use in oral medicines. 1866 DIMETHYLOL DIMETHYL HYDANTOIN E Only for use in topical medicines for dermal application. 1867 DIMETICONE 1.5 E Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must not be more than 23%. 1868 DIMETICONE 10 E 1869 DIMETICONE 100 E Only for use in topical medicines for dermal application. 1870 DIMETICONE 1000 E 1871 DIMETICONE 1510 E Permitted for use only in combination with other permitted ingredients as a printing ink. If used in a printing ink the total printing ink concentration in a medicine must be no more than 0.1% 1872 DIMETICONE 2 E Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 9.602%. 1873 DIMETICONE 20 E Only for use in topical medicines for dermal application. 1874 DIMETICONE 200 E Only for use in topical medicines for dermal application. 1875 DIMETICONE 30 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. 1876 DIMETICONE 350 E Only for use in topical and oral medicines. When used orally, the maximum daily dose must be no more than 7.5mg. 1877 DIMETICONE 360 E Only for use in topical medicines for dermal application. 1878 DIMETICONE 450 E Only for use in topical medicines for dermal application. 1879 DIMETICONE 5 E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 10%. 1880 DIMETICONE 50 E Only for use in topical medicines for dermal application. 1881 DIMETICONE 5000 E Only for use in topical medicines for dermal application. 1882 DIMETICONE 6 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. 1883 DIMETICONE COPOLYOL E Only for use in topical medicines for dermal application. 1884 DIMETICONE COPOLYOL PHOSPHATE E Only for use in topical medicines for dermal application. 1885 DIMETICONE CROSSPOLYMER-3 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 15%. 1886 DIMETICONE/PEG-10/15 CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 1887 DIMETICONOL E Only for use in topical medicines for dermal application. 1888 DIMETICONOL STEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 1889 DIMETICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or damaged skin. The concentration in the medicine must not be more than 10%. 1890 DIMOCARPUS LONGAN A, H 1891 DIOCTYL ADIPATE E Only for use in topical medicines for dermal application. 1892 DIOCTYL MALEATE E Only for use in topical medicines for dermal application. 1893 DIOCTYL SUCCINATE E Only for use in topical medicines for dermal application. 1894 DIOCTYL TEREPHTHALATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1895 DIOLAMINE C8-18 PERFLUOROALKYLETHYL PHOSPHATE E Only for use in topical medicines for dermal application and not be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 0.7% 1896 DIOLAMINE CETYL PHOSPHATE E Only for use in topical medicines for dermal application and not be included in topical medicines intended for use in the eye. 1897 DIOSCOREA COLLETTII A, H 1898 DIOSCOREA COLLETTII VAR. HYPOGLAUCA A, H 1899 DIOSCOREA JAPONICA A, H 1900 DIOSCOREA OPPOSITIFOLIA A, H 1901 DIOSCOREA POLYSTACHYA A, H 1902 DIOSCOREA SEPTEMLOBA A, H 1903 DIOSCOREA VILLOSA A, E, H 1904 DIOSPYROS KAKI A, E, H 1905 DIOXYBENZONE A Only for use as an active ingredient in sunscreens for dermal application. The concentration in the medicine must be no more than 3%. When used in primary sunscreen products, the medicine requires the following warning statements on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 1906 DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin. The concentration in the medicine must be no more than 0.5%. 1907 DIPENTAERYTHRITYL TETRAHYDROXYSTEARATE/TETRAISOSTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 1908 DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 1909 DIPHENYL DIMETHICONE E Only for use in topical medicines for dermal application. 1910 DIPHENYL METHANE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1911 DIPHENYL OXIDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1912 DIPOTASSIUM GLYCYRRHIZATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 1913 DIPROPIONYL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1914 DIPROPYLENE GLYCOL E Only for use in topical medicines for dermal application. 1915 DIPROPYLENE GLYCOL DIBENZOATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4.2%. 1916 DIPROPYLENE GLYCOL SALICYLATE E Only for use in topical medicines for dermal application. 1917 DIPSACUS ASPER A, H 1918 DIPSACUS JAPONICUS A, H 1919 DIPTERYX ODORATA A, E, H When used as an active ingredient coumarin is a mandatory component of Dipteryx odorata and the concentration of coumarin in the medicine must be no more than 0.001%. 1920 DISODIUM ASCORBYL SULFATE E Only for use in topical medicines for dermal application. 1921 DISODIUM COCOAMPHODIACETATE E Only for use in topical medicines for dermal application. 1922 DISODIUM COCOAMPHODIPROPIONATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 1923 DISODIUM DIMETICONE COPOLYOL SULFOSUCCINATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 14%. 1924 DISODIUM EDETATE E Edetic acid is a mandatory component of disodium edetate. The total concentration of edetic acid in the medicine must not be more than 0.25%. 1925 DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 1%. 1926 DISODIUM GUANYLATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1927 DISODIUM INOSINATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1928 DISODIUM LAURIL SULFOSUCCINATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 0.35%. 1929 DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. 1930 DISODIUM NADH E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.02%. 1931 DISODIUM OLEAMIDO PEG-2 SULFOSUCCINATE E Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye. The concentration in the medicine must be no more than 1%. 1932 DISODIUM PHENYL DIBENZIMIDAZOLE TETRASULFONATE A Only for use as an active ingredient in sunscreens for dermal application. The concentration in the medicine must be no more than 10%. When used in primary sunscreen products, the medicine requires the following warning statements on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 1933 DISODIUM PYROPHOSPHATE E Disodium pyrophosphate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing disodium pyrophosphate must not be more than 5% of the total medicine. The maximum recommended daily dose of the medicine must not provide more than 2.4 g of phosphorus. The following statement (or words to the same effect) is required on the medicine label: - (PHOS) 'Contains phosphorus'. 1934 DISODIUM RICINOLEAMIDO MEA-SULFOSUCCINATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. 1935 DISODIUM RUTINYL DISULFATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.05%. 1936 DISODIUM STEAROYL GLUTAMATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 1937 DISPERSIBLE CELLULOSE E 1938 DISTARCH PHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. 1939 DISTEARDIMONIUM HECTORITE E Only for use in topical medicines for dermal application and not to be included for medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 1940 DISTEARETH-6 DIMONIUM CHLORIDE E Only for use in topical medicines for dermal application. 1941 DISTEARYL PHTHALIC ACID AMIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 1942 DISTEARYLDIMONIUM CHLORIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 1943 DIVINYLDIMETHICONE/DIMETHICONE COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%. 1944 DL-ALPHA-TOCOPHEROL A, E 1945 DL-ALPHA-TOCOPHERYL ACETATE A, E, H 1946 DL-ALPHA-TOCOPHERYL ACID SUCCINATE A, E, H 1947 DL-BORNEOL E 1948 DL-LIMONENE E Only for use in topical medicines for dermal application. 1949 DL-THREONINE A, E 1950 DOCOSAHEXAENOIC ACID (DHA)-RICH OIL DERIVED FROM MICROALGAE SCHIZOCHYTRIUM SP. A Only for use in oral medicines and must be present in combination with other ingredients. 1951 DOCUSATE SODIUM E 1952 DODECAHYDRO-3A,6,6,9A-TETRAMETHYLNAPHTHO(2,1-B)FURAN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1953 DODECANENITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 1954 DODECENE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. 1955 DODECYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1956 DODECYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1957 DOLICHOS LABLAB A, H 1958 DOLOMITE A, E, H 1959 DRACAENA DRACO A, H 1960 DRIED BUTTERMILK E 1961 DRIED CALCIUM SULFATE A, E, H 1962 DRIED MAGNESIUM SULFATE A, E, H When used internally, the maximum recommended daily dose must be no more than 1.5g. Magnesium is a mandatory component of dried magnesium sulfate. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 1963 DRIMIA INDICA A, H 1964 DRIMIA MARITIMA A, H 1965 DROMETRIZOLE TRISILOXANE A Only for use as an active ingredient in sunscreens for dermal application. The concentration in a medicine must be no more than 10%. When used in primary sunscreen products, the medicine requires the following warning statements on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 1966 DROSERA ANGLICA A, H 1967 DROSERA BURMANNI A, H 1968 DROSERA INTERMEDIA A, H 1969 DROSERA RAMENTACIA A, H 1970 DROSERA ROTUNDIFOLIA A, E, H 1971 DROSERA ROTUNDIFOLIA MIS A, H 1972 DRYNARIA FORTUNEI A, H 1973 DRYOBALANOPS AROMATICA A, H 1974 DRYOPTERIS FILIX-MAS H Only for use as an active homoeopathic ingredient. 1975 DULACIA INOPIFLORA A, H 1976 DUNALIELLA SALINA A, E, H 1977 DURVILLAEA ANTARCTICA EXTRACT E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%. 1978 DWARF PINE-NEEDLE OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 1979 DYSPHANIA AMBROSIOIDES A, H Volatile oil components (of Dysphania ambrosioides) are mandatory components of Dysphania ambrosioides. 1980 ECAMSULE A Only for use as an active ingredient in sunscreens for dermal application. The concentration in the medicine must be no more than 10%. When used in primary sunscreen products, the medicine requires the following warning statements on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 1981 ECHINACEA ANGUSTIFOLIA A, E, H 1982 ECHINACEA PALLIDA A, E, H 1983 ECHINACEA PURPUREA A, E, H 1984 ECHINOPA SPINOSISSIMUS A, H 1985 ECLIPTA PROSTRATA A, H 1986 ECTOINE E Only for use as an excipient ingredient in topical medicines for dermal application and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. 1987 EDETATE SODIUM E Only for use in topical medicines for dermal application and nasal medicines. The concentration in the medicine must be no more than 0.2%. 1988 EDETIC ACID E The concentration in the medicine must be no more than 0.25%. 1989 EGG LECITHIN A, E 1990 EGGSHELL MEMBRANE HYDROLYSATE A 1991 EGGSHELL MEMBRANE POWDER A 1992 ELAEAGNUS ANGUSTIFOLIA A, H 1993 ELAEIS GUINEENSIS A, E, H 1994 ELASTIN E Only for use in topical medicines for dermal application. 1995 ELDER FLOWER ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 1996 ELDER FLOWER BLACK DRY A, E, H 1997 ELDER FLOWER BLACK POWDER A, H 1998 ELECAMPANE RHIZOME DRY A, H 1999 ELECAMPANE RHIZOME POWDER A, H 2000 ELEMI OIL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2001 ELEMI RESINOID E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2002 ELEMOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2003 ELEOCHARIS DULCIS A, H 2004 ELETTARIA CARDAMOMUM A, E, H 2005 ELEUTHEROCOCCUS NODIFLORUS A, H 2006 ELEUTHEROCOCCUS ROOT DRY A, H 2007 ELEUTHEROCOCCUS ROOT POWDER A, H 2008 ELEUTHEROCOCCUS SENTICOSUS A, H 2009 ELSHOLTZIA SPLENDENS A, H 2010 ELYMUS REPENS A, E, H 2011 EMU OIL A, E Emu oil ingredients must meet the following two requirements: 1) the manufacturing process is to include steps such as cooking, fat drying or deodorising which ensures the temperature of the oil reaches at least 60 degrees C for a minimum 5 minutes or at least 100 degrees C for a minimum of 1 minute, and 2) the sponsor is to hold a veterinary certificate indicating that the emus from which the raw material was extracted were healthy and fit for human consumption. 2012 EMULSIFYING WAX E 2013 ENOXOLONE E Only for use in topical medicines for dermal application. 2014 ENZYME MODIFIED CREAM E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2015 EPA-RICH NANNOCHLOROPSIS OCULATA OIL A, E The route of administration for medicines that contain EPA-rich Nannochloropsis oculata oil must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 2000 mg of EPA-rich Nannochloropsis oculata oil. The following warning statements (or words to the same effect) must be included on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women'; and - (ADULT) 'Adults only'. 2016 EPHEDRA DISTACHYA A, H Ephedrine and Pseudoephedrine (of Ephedra distachya) are mandatory components of Ephedra distachya and must be declared in the application. The concentration of ephedrine from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 2017 EPHEDRA SINICA A, H Ephedrine and Pseudoephedrine (of Ephedra sinica) are mandatory components of Ephedra sinica. The concentration of ephedrine from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 2018 EPIGAEA REPENS A, H 2019 EPILOBIUM ANGUSTIFOLIUM E Only for use in topical sunscreens for dermal application and not to be included in medicines intended for use in the eye. The extract must be processed from the flower, leaf and stem (herb top flowering) of the plant. The extracts used must be: 1:20 in 100% water or 1:2 in 100% water. The concentrations of Epilobium angustifolium must be no more than 0.75% for a 1:2 extract in 100% water, and 5% for a 1:20 extract in 100% water. 2020 EPILOBIUM PALUSTRE A, H 2021 EPILOBIUM PARVIFLORUM A, H 2022 EPIMEDIUM BREVICORNU A, H 2023 EPIMEDIUM GRANDIFLORUM A, H 2024 EPIMEDIUM SAGITTATUM A, H 2025 EQUISETUM ARVENSE A, E, H 2026 EQUISETUM HIEMALE A, H 2027 ERGOCALCIFEROL A, E When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D. 2028 ERGOTHIONEINE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.0005%. 2029 ERIGERON BREVISCAPUS A, H 2030 ERIOBOTRYA JAPONICA A, H Amygdalin and hydrocyanic acid are mandatory components. The concentration of amygdalin in the medicine must be 0%. The concentration of hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 2031 ERIOCAULON BUERGERIANUM A, H 2032 ERIODICTYON CRASSIFOLIUM A, H 2033 ERIODICTYON GLUTINOSUM A, H 2034 ERODIUM CICUTARIUM A, H 2035 ERUCA SATIVA A, H 2036 ERYTHORBIC ACID E 2037 ERYTHRITOL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 2038 ERYTHROSINE E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 2039 ERYTHROSINE ALUMINIUM LAKE E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 2040 ERYTHRULOSE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. The medicine requires the following warning statement on the medicine label: - (EYE) 'Avoid contact with eyes'. 2041 ESCHSCHOLZIA CALIFORNICA A, H 2042 ESTRONE H Only for use as an active homoeopathic ingredient. The total concentration of estrone in the medicine must not be more than 100 micrograms/kg or 100 micrograms/L or 0.00001%. 2043 ETHANOL A, E When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 2044 ETHANOL ABSOLUTE A, E When ethanol absolute is used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 2045 ETHER E The concentration of ether in the medicine must be no more than 10%. 2046 ETHOHEXADIOL E Only for use in topical medicines for dermal application. The total concentration of ethohexadiol in the medicine must not be more than 5%. 2047 ETHOXYLATED HYDROGENATED CASTOR OIL E 2048 ETHOXYLATED NONYLPHENOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2049 ETHOXYMETHOXY CYCLODODECANE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2050 ETHYL (2,4-DIMETHYL-[1,3] DIOXOLAN-2-YL) ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2051 ETHYL (3AR,4S,7R,7AR)-REL- OCTAHYDRO-4,7-METHANO[3AH]INDENE-3A-CARBOXYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2052 ETHYL 2,3,6,6-TETRAMETHYL-2-CYCLOHEXENECARBOXYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2053 ETHYL 2,6,6,TRIMETHYL-1,3-CYCLOHEXADIENE-1-CARBOXYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2054 ETHYL 2-BUTENOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2055 ETHYL 2-ETHYL-6,6-DIMETHYL-2-CYCLOHEXENECARBOXYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2056 ETHYL 2-HEXYL ACETOACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2057 ETHYL 2-METHYLBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2058 ETHYL 2-METHYLPENTANOATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2059 ETHYL 3-HEXENOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2060 ETHYL 3-HYDROXYBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2061 ETHYL 3-HYDROXYHEXANOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2062 ETHYL 3-MERCAPTOPROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2063 ETHYL 3-METHYLTHIOPROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2064 ETHYL 4,7-OCTADIENOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2065 ETHYL ACETATE E The residual solvent limit for ethyl acetate is 50 mg per recommended daily dose. The concentration in the medicine must be no more than 0.5%. 2066 ETHYL ACETOACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2067 ETHYL ACRYLATE E 2068 ETHYL AMYL KETONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2069 ETHYL ANTHRANILATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2070 ETHYL BENZOATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2071 ETHYL BENZOYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2072 ETHYL BUTYLACETYLAMINOPROPIONATE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 7.5%. The medicine requires the following warning statement on the medicine label: - (EYE2) 'May be irritant to the eyes (or words to that effect)'. 2073 ETHYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2074 ETHYL CAPRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2075 ETHYL CAPROATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2076 ETHYL CAPRYLATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2077 ETHYL CINNAMATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2078 ETHYL CROTONATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2079 ETHYL ENANTATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2080 ETHYL FORMATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2081 ETHYL HYDROXYBENZOATE E 2082 ETHYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2083 ETHYL ISOVALERATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2084 ETHYL LACTATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2085 ETHYL LAURATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2086 ETHYL LEVULATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2087 ETHYL LEVULINATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2088 ETHYL LINALOOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2089 ETHYL LINALYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2090 ETHYL LINOLEATE E Only for use in topical medicines for dermal application. 2091 ETHYL LINOLENATE E Only for use in topical medicines for dermal application. 2092 ETHYL MACADAMIATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. 2093 ETHYL MALTOL E 2094 ETHYL MENTHANE CARBOXAMIDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2095 ETHYL METHACRYLATE E Only for use in topical medicines for dermal application. Only permitted in medicines containing 1% or less of ethyl methacrylate as residual monomer in a polymer. 2096 ETHYL METHYLPHENYLGLYCIDATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2097 ETHYL METICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. 2098 ETHYL MYRISTATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2099 ETHYL OLEATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2100 ETHYL ORTHO-METHOXYBENZYL ETHER E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2101 ETHYL OXYHYDRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2102 ETHYL PALMITATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2103 ETHYL PARA-ANISATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2104 ETHYL PELARGONATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2105 ETHYL PHENYLACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2106 ETHYL PHENYLGLYCIDATE E Ethyl phenylglycidate must only be used in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The concentration of ethyl phenylglycidate in a medicine must not be more than 0.0000024% w/w (equivalent to 24 parts per billion). 2107 ETHYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2108 ETHYL PYRUVATE E Ethyl pyruvate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of the flavour proprietary excipient formulation containing ethyl pyruvate must not be more than 5% of the total medicine. 2109 ETHYL RICINOLEATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2110 ETHYL SALICYLATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2111 ETHYL SEBACATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2112 ETHYL STEARATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2113 ETHYL SUCCINATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2114 ETHYL TARTRATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2115 ETHYL TRANS-2, CIS-4-DECADIENOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2116 ETHYL TRANS-2-HEXENOATE E Ethyl trans-2-hexenoate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing ethyl trans-2-hexenoate must not be more than 5% of the total medicine. 2117 ETHYL TRANS-3-HEXENOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2118 ETHYL UNDECYLENATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2119 ETHYL VALERATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2120 ETHYL VANILLIN E 2121 ETHYL-2-METHYL-1,3-DIOXOLANE-2-ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2122 ETHYL-2-METHYL-4-PENTENOATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2123 ETHYL-2-METHYLPENTENOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2124 ETHYLBISIMINOMETHYL GUAIACOL MANGANESE CHLORIDE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.002%. 2125 ETHYLCELLULOSE E 2126 ETHYLENE BRASSYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2127 ETHYLENE GLYCOL E The residual solvent limit for ethylene glycol is 6.2 mg per recommended daily dose. The concentration in the medicine must be no more than 0.062%. 2128 ETHYLENE GLYCOL MONOPALMITOSTEARATE E Only for use in topical medicines for dermal application. 2129 ETHYLENE/ACRYLIC ACID COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. 2130 ETHYLENE/VINYL ACETATE COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 16%. 2131 ETHYLENEDIAMINE E Only for use in topical medicines for dermal application. 2132 ETHYLENEDIAMINE/HYDROGENATED DIMER DILINOLEATE COPOLYMER BIS-DI-C14-18 ALKYL AMIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. 2133 ETHYLENEDIAMINE/STEARYL DIMER DILINOLEATE COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 6%. 2134 ETHYLHEXYL BENZOATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 3.5%. 2135 ETHYLHEXYL METHOXYCRYLENE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. 2136 ETHYLHEXYL TRIAZONE A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 5%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 2137 ETHYLHEXYLGLYCERIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 2138 ETIDRONIC ACID E Only for use in topical medicines for dermal application only. The concentration in the medicine must be no more than 1%. 2139 EUCALYPTUS DIVES A, E, H Cineole is a mandatory component of Eucalyptus dives. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 2140 EUCALYPTUS FRUTICETORUM A, E, H Cineole is a mandatory component of Eucalyptus fruticetorum. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 2141 EUCALYPTUS GLOBULUS A, E, H Cineole is a mandatory component of Eucalyptus globulus. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 2142 EUCALYPTUS MACRORHYNCHA A, E, H Cineole is a mandatory component of Eucalyptus macrorhyncha. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 2143 EUCALYPTUS OIL A, E, H Cineole is a mandatory component of eucalyptus oil. When the concentration of eucalyptus oil in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres. When the concentration of eucalyptus oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but no more than 25 millilitres, a child resistant closure and restricted flow insert must be fitted on the container. The medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. When the concentration of eucalyptus oil in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, a restricted flow insert must be fitted on the container. The medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and -(NTAKEN) 'Not to be taken'. 2144 EUCALYPTUS RADIATA A, E, H Cineole is a mandatory component of Eucalyptus radiata. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 2145 EUCALYPTUS ROSTRATA A, E, H Cineole is a mandatory component of Eucalyptus rostrata. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 2146 EUCALYPTUS TERETICORNIS A, E, H Cineole is a mandatory component of Eucalyptus tereticornis. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 2147 EUCOMMIA ULMOIDES A, H 2148 EUGENOL E When for oral ingestion, eugenol must not comprise more than 0.06% of the formulation. When used in topical medicines for dermal application, the following apply: a) When the concentration of Eugenol in the preparation is more than 25%, the nominal capacity of the container must be no more than 25 mL. b) When the concentration of Eugenol in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL but no more than 25mL, a child resistant closure and restricted flow insert must be fitted on the container. The medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect) - (NTAKEN) 'Not to be taken' c) When the concentration of Eugenol in the preparation is more than 25% and the nominal capacity of the container is no more than 15mL, a restricted flow insert must be fitted on the container. The medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect) - (NTAKEN) 'Not to be taken' 2149 EUGENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2150 EUGLENA GRACILIS WHOLE CELL DRY A The route of administration for medicines that contain Euglena gracilis whole cell dry must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than: (a) 100 mg of Euglena gracilis whole cell dry for children aged between 1 and 3 years (inclusive); (b) 150 mg of Euglena gracilis whole cell dry for children aged between 4 and 8 years (inclusive); (c) 225 mg of Euglena gracilis whole cell dry for individuals aged between 9 and 18 years (inclusive); and (d) 375 mg of Euglena gracilis whole cell dry for adults aged 19 years or older. The following warning statement (or words to the same effect) must be included on the medicine label: - (BABY2) 'Not suitable for infants under the age of twelve months'. 2151 EUONYMUS ATROPURPUREUS A, H 2152 EUONYMUS EUROPAEUS A, H The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material. 2153 EUPATORIUM FORTUNEI A, H 2154 EUPATORIUM JAPONICUM A, H 2155 EUPATORIUM PERFOLIATUM A, H 2156 EUPATORIUM PURPUREUM A, H 2157 EUPHAUSIA SUPERBA OIL A Only for use in oral medicines. 2158 EUPHORBIA CYPARISSIAS A, H 2159 EUPHORBIA DRY A, H 2160 EUPHORBIA HETERODOXA A, H 2161 EUPHORBIA HIRTA A, H 2162 EUPHORBIA LATHYRIS A Levodopa is a mandatory component of Euphorbia lathyris. The concentration of levodopa in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 2163 EUPHORBIA PEKINENSIS A, H 2164 EUPHORBIA PEPLUS H Only for use as an active homoeopathic ingredient. 2165 EUPHORBIA POWDER A, H 2166 EUPHORBIA RESINIFERA A, H 2167 EUPHORBIA SIEBOLDIANA A, H 2168 EUPHRASIA OFFICINALIS A, H 2169 EUROPEAN GARDEN SPIDER H Only for use as an active homoeopathic ingredient. 2170 EUROPEAN HORNET H Only for use as an active homoeopathic ingredient. 2171 EURYALE FEROX A, H 2172 EUTERPE OLERACEA A, E The plant part must be derived from the fruit. When used as an excipient: - permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation; - the total flavour proprietary excipient formulation in a medicine must not be more than 5%; and - the following warning statement is required on the medicine label: - (ACAI) 'Contains acai'. 2173 EVENING PRIMROSE OIL A, E, H 2174 EVERNIA PRUNASTRI EXTRACT E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine Note: See sections 5 and 6. Permissible ingredients and requirements Column 1 Column 2 Column 3 Column 4 Item Ingredient name Purpose Specific requirements 2175 FABIANA IMBRICATA A, H 2176 FAGOPYRUM ESCULENTUM A, H 2177 FAGUS GRANDIFOLIA A, H 2178 FAGUS SYLVATICA A, H 2179 FARNESOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2180 FARNESYL ACETATE E Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 2181 FAST GREEN FCF E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 2182 FENCHONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2183 FENCHYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2184 FENCHYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2185 FENNEL BITTER SEED DRY A, E, H When used in oral medicines, the following warning statements are required on the label: - (CHILD3) 'Use in children under 12 years is not recommended' - (PREGNT2) 'Do not use if pregnant or likely to become pregnant (or words to that effect)' - (BREASF) 'Do not use while breastfeeding.' 2186 FENNEL LEAF E 2187 FENNEL OIL A, E, H Methyl chavicol is a mandatory component of fennel oil. When the concentration of methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL, a restricted flow insert must be fitted on the container, and the following warning statement is required on the label: - (CHILD) 'Keep out of reach of children (or words to that effect).' The maximum daily dose must provide no more than 150 mg of fennel oil. When used in oral medicines, the following warning statements are required on the label: - (CHILD3) 'Use in children under 12 years is not recommended.' - (PREGNT2) 'Do not use if pregnant or likely to become pregnant (or words to that effect).' - (BREASF) 'Do not use while breastfeeding.' 2188 FENNEL SWEET SEED DRY A, E, H When used in oral medicines, the following warning statements are required on the label: - (CHILD3) 'Use in children under 12 years is not recommended' - (PREGNT2) 'Do not use if pregnant or likely to become pregnant (or words to that effect)' - (BREASF) 'Do not use while breastfeeding.' 2189 FENUGREEK E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2190 FENUGREEK OIL E Fenugreek oil is permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2191 FERRIC AMMONIUM CITRATE A, E, H When for internal use, iron is a mandatory component of ferric ammonium citrate. When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the following warning statement is required on the label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2192 FERRIC CHLORIDE A, E, H When for internal use, iron is a mandatory component of ferric chloride. When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2193 FERRIC CHLORIDE HEXAHYDRATE A, E, H When for internal use, iron is a mandatory component of ferric chloride hexahydrate. When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2194 FERRIC GLYCEROPHOSPHATE A, E, H When for internal use, iron is a mandatory component of ferric glycerophosphate. When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2195 FERRIC OXIDE E 2196 FERRIC PHOSPHATE H Only for use as an active homoeopathic ingredient. 2197 FERRIC PYROPHOSPHATE A, H When for internal use, iron is a mandatory component of ferric pyrophosphate. When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2198 FERROSOFERRIC OXIDE E When used in undivided preparations for internal use and the concentration of iron oxide in the medicine is more than 1%, it is considered part of the total iron content. When used in divided preparations for internal use, the concentration in the medicine must be no more than 10 mg per dosage unit. 2199 FERROSOFERRIC PHOSPHATE H Only for use as an active homoeopathic ingredient. 2200 FERROUS FUMARATE A, H When for internal use, iron is a mandatory component of ferrous fumarate. When used as an active ingredient, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5mg of elemental iron per dosage unit and more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2201 FERROUS GLUCONATE A, E, H When for internal use, iron is a mandatory component of ferrous gluconate. When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2202 FERROUS GLUCONATE DIHYDRATE A, E, H When for internal use, iron is a mandatory component of ferrous gluconate dihydrate. When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2203 FERROUS IODIDE H Only for use as an active homoeopathic ingredient. 2204 FERROUS LACTATE TRIHYDRATE A, E, H When for internal use, iron is a mandatory component of ferrous lactate trihydrate. When used as an active ingredient, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than1%). Divided preparations with a dose of more than 5mg of elemental iron per dosage unit and more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2205 FERROUS PHOSPHATE OCTAHYDRATE A, E, H When for internal use, iron is a mandatory component of ferrous phosphate octahydrate. When used as an active ingredient, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5mg of elemental iron per dosage unit and more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2206 FERROUS PICRATE H Only for use as an active homoeopathic ingredient. 2207 FERROUS SULFATE A, E, H When used as an active ingredient, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5mg of elemental iron per dosage unit and more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2208 FERROUS SULFATE HEPTAHYDRATE A, E, H When for internal use, iron is a mandatory component of ferrous sulfate heptahydrate. When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2209 FERULA ASSA-FOETIDA A, E, H 2210 FERULA FOETIDA A, E, H 2211 FERULA GALBANIFLUA A, E, H 2212 FERULA RUBRICAULIS A, E, H 2213 FERULA SUMBUL A, H 2214 FERULIC ACID E Only for use in topical medicines for dermal application. 2215 FESTUCA ELATIOR A, H 2216 FEVERFEW HERB DRY A, H 2217 FEVERFEW HERB POWDER A, H 2218 FICUS CARICA A, E, H 2219 FICUS PUMILA A, H 2220 FIG E 2221 FIG DRY A, H 2222 FILIPENDULA ULMARIA A, H Methyl salicylate is a mandatory component of Filipendula ulmaria. Not to be included in medicines for use in the eye or on damaged skin. When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is spray, the medicine does not require child resistant packaging if: - the delivery device is engaged into the container in such a way that prevents it from being readily removed; - direct suction through the delivery device results in delivery of no more than one dosage unit; and - actuation of the spray device is ergonomically difficult for young children to accomplish. The following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect). When for use in topical medicines for dermal application: i) the concentration of methyl salicylate in the medicine must not be more than 25%; ii) the following warning statements are required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less'; - (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect); - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect); iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label: - (IRRIT) 'If irritation develops, discontinue use'. 2223 FIR BALSAM ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2224 FIR NEEDLE OIL CANADIAN A, E 2225 FIR NEEDLE OIL SIBERIAN A, E 2226 FIRMIANA SIMPLEX A, E, H 2227 FISH OIL - RICH IN OMEGA-3 ACIDS A Only for use in oral medicines. 2228 FLEMINGIA MACROPHYLLA A, H 2229 FLOUVE OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2230 FLUORESCEIN SODIUM E 2231 FOENICULUM VULGARE A, E, H When used in oral medicines, the following warning statements are required on the label: - (CHILD3) 'Use in children under 12 years is not recommended' - (PREGNT2) 'Do not use if pregnant or likely to become pregnant (or words to that effect)' - (BREASF) 'Do not use while breastfeeding.' When the plant preparation is oil or distillate, methyl chavicol is a mandatory component and the maximum daily dose must provide no more than 150 mg of the plant preparation. When the plant preparation is oil or distillate and the concentration of methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL, a restricted flow insert must be fitted on the container, and the following warning statement is required on the label: - (CHILD) 'Keep out of reach of children' (or words to that effect). 2232 FOLIC ACID A When for internal use, the maximum recommended daily dose must not provide more than 500 micrograms of folic acid. When the medicine contains a combination of folic acid, folinic acid or levomefolic acid, the medicine must not provide more than a combined total of 500 micrograms of folic acid, folinic acid and levomefolic acid per maximum recommended daily dose. 2233 FOOD ORANGE 6 E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 2234 FOOD ORANGE 7 E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 2235 FOOD RED 13 E Permitted for use only as a colour for topical use. 2236 FORMALDEHYDE/MELAMINE/TOSYLAMIDE COPOLYMER E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 10%. 2237 FORMIC ACID E, H Formic acid must only be included in medicines: (a) as an active homoeopathic ingredient; or (b) when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing formic acid must not be more than 5% of the total medicine. The maximum recommended daily dose of the medicine must not provide more than 150 mg of formic acid. The total concentration of formic acid in the medicine must not be more than 0.5%. 2238 FORSYTHIA SUSPENSA A, H 2239 FORTIFIED WINE E Ethanol is a mandatory component of fortified wine. 2240 FRACTIONATED COCONUT OIL E 2241 FRACTIONATED PALM KERNEL OIL A, E When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 2242 FRAGARIA CHILOENSIS A, E, H 2243 FRAGARIA VESCA A, E, H 2244 FRAGARIA VIRGINIANA A, E, H 2245 FRAGARIA X ANANASSA A, E, H 2246 FRANGULA BARK DRY A, H Glucofrangulins calculated as glucofrangulin A is a mandatory component of Frangula bark dry. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect]. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' [or words to that effect]. When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' [or words to that effect]; and - (LAX2) 'Prolonged use may cause serious bowel problems'. 2247 FRANGULA BARK POWDER A, H Glucofrangulins calculated as glucofrangulin A is a mandatory component of Frangula bark powder. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product [or words to that effect]'. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water [or words to that effect]'. When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water [or words to that effect]'; and - (LAX2) 'Prolonged use may cause serious bowel problems'. 2248 FRANGULA PURSHIANA A, H When for oral use, hydroxyanthracene derivatives calculated as cascaroside A is a mandatory component of Frangula purshiana. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect]. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' [or words to that effect]. When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' [or words to that effect]; and - (LAX2) 'Prolonged use may cause serious bowel problems'. 2249 FRAXINUS AMERICANA A, H 2250 FRAXINUS CHINENSIS SUBSP. RHYNCHOPHYLLA A, H 2251 FRAXINUS EXCELSIOR A, H 2252 FRAXINUS ORNUS A, H 2253 FRITILLARIA CIRRHOSA A, H 2254 FRITILLARIA THUNBERGII A, H 2255 FRITILLARIA VERTICILLATA A, H 2256 FRUCTOOLIGOSACCHARIDES A, E 2257 FRUCTOSE A, E, H 2258 FUCUS VESICULOSUS A, E, H Iodine is a mandatory component of Fucus vesiculosus. Only for external use when the concentration of available iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 2259 FULLY HYDROGENATED RAPESEED OIL E Fully hydrogenated rapeseed oil must only be used in topical medicines for dermal application. The total concentration of fully hydrogenated rapeseed oil in the medicine must not be more than 5%. 2260 FUMARIA OFFICINALIS A, E, H 2261 FUMARIC ACID E, H Only for use as an active homoeopathic or excipient ingredient. 2262 FUMITORY HERB DRY A, H 2263 FUMITORY HERB POWDER A, H 2264 FURAMINTON E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2265 FURFURAL E Permitted for use only in medicines containing 0.1% or less of furfural and in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must not be more than 5%. If used in a fragrance the total fragrance concentration in a medicine must not be more than 1%. 2266 FURFURYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2267 FURFURYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2268 FURFURYL MERCAPTAN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2269 FUSEL OIL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2270 GALACTOOLIGOSACCHARIDES A Only to be used in a medicine where FrieslandCampina Ingredients B V (Client ID 79530), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 1 May 2025. Lactose and glucose are mandatory components of galactooligosaccharides. The route of administration for medicines that contain galactooligosaccharides must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than: (a) 8 g of galactooligosaccharides to individuals aged 0 to 3 years (inclusive); and (b) 16.2 g of galactooligosaccharides to individuals aged 4 years and older. The following warning statement (or words to the same effect) is required on the medicine label: (GOS) 'Not to be taken on the same day with other products containing galactooligosaccharides.' 2271 GALBANUM OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2272 GALBANUM RESIN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2273 GALBANUM RESINOID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2274 GALEGA OFFICINALIS A, H 2275 GALEOPSIS SEGETUM A, H 2276 GALIUM APARINE A, H 2277 GALIUM ODORATUM A, H When used as an active ingredient coumarin is a mandatory component of Galium odoratum and the concentration of coumarin in the medicine must be no more than 0.001%. 2278 GALIUM PALUSTRE A, H 2279 GALIUM VERUM A, H 2280 GALL STONE H Only for use as an active homoeopathic ingredient. 2281 GALPHIMIA GLAUCA A, H 2282 GAMMA-4-DIMETHYL-3-CYCLOHEXENE-1-PROPANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2283 GAMMA-BUTYROLACTONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2284 GAMMA-CYCLODEXTRIN E 2285 GAMMA-DECALACTONE E Permitted for use only: (a) in topical medicines for dermal application; and (b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. 2286 GAMMA-DODECALACTONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2287 GAMMA-HEPTALACTONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2288 GAMMA-HEXALACTONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2289 GAMMA-IONONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2290 GAMMA-LINOLEIC ACID E Only for use in topical medicines for dermal application. 2291 GAMMA-LINOLENIC ACID E 2292 GAMMA-N-METHYL IONONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2293 GAMMA-NONALACTONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2294 GAMMA-OCTALACTONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2295 GAMMA-TERPINENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2296 GAMMA-TOCOPHEROL E 2297 GAMMA-UNDECALACTONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2298 GAMMA-VALEROLACTONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2299 GANODERMA LUCIDUM A, E, H 2300 GARCINIA GUMMI-GUTTA A The requirements specified in paragraphs (a) to (c) below applies to a medicine that contains the ingredient that is: - listed in the Register before 1 March 2025; and - released for supply before 1 March 2026: (a) Only for use in oral medicines. (b) Must be obtained from the rind of the fruit only. (c) Must not contain any directions for use for children or pregnant or lactating women. The requirements specified in paragraphs (d) to (g) below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026: (d) The route of administration for medicines that contain Garcinia gummi-gutta must be limited to oral. (e) The plant part must be limited to fruit peel. (f) The following warning statement is required on the medicine label: 'In very rare cases, Garcinia gummi-gutta may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.' (g) Medicines containing Garcinia gummi-gutta must not be directed for use in children, or in pregnant or lactating women. 2301 GARCINIA QUAESITA A, H The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. When for oral use, the following warning statement is required on the medicine label: 'In very rare cases, Garcinia quaesita may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.' Medicines containing Garcinia quaesita must not be directed for use in children, or in pregnant or lactating women. 2302 GARDEN BEAN E 2303 GARDENIA JASMINOIDES A, E 2304 GARDENIA TAHITENSIS FLOWER EXTRACT E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.002% 2305 GARLIC BULB DRY A, E, H 2306 GARLIC BULB FRESH A, H 2307 GARLIC BULB POWDER A, E, H 2308 GARLIC CLOVE POWDER A, H 2309 GARLIC OIL A, E, H 2310 GASTRODIA ELATA A, H 2311 GAULTHERIA PROCUMBENS A, E, H Methyl salicylate is a mandatory component of Gaultheria procumbens. Not to be included in medicines for use in the eye or on damaged skin. When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is spray, the medicine does not require child resistant packaging if: - the delivery device is engaged into the container in such a way that prevents it from being readily removed; - direct suction through the delivery device results in delivery of no more than one dosage unit; and - actuation of the spray device is ergonomically difficult for young children to accomplish. The following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect). When for use in topical medicines for dermal application i) the concentration of methyl salicylate in the medicine must not be more than 25%; ii) the following warning statements are required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less'; - (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect); - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect); iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label: - (IRRIT) 'If irritation develops, discontinue use'. 2312 GELATIN A, E 2313 GELIDIUM AMANSII A, H Iodine is a mandatory component of Gelidium amansii. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 2314 GELLAN GUM E 2315 GELSEMIUM DRY A, H The concentration of Gelsemium dry in the medicine must be no more than 1mg/Kg or 1mg/L or 0.0001%. 2316 GELSEMIUM POWDER A, H 2317 GELSEMIUM SEMPERVIRENS A, H The concentration of equivalent dry Gelsemium sempervirens in the product must be no more than 1mg/Kg or 1mg/L or 0.0001%. 2318 GENET ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2319 GENTIAN DRY A, H 2320 GENTIAN POWDER A, H 2321 GENTIANA LUTEA A, E, H 2322 GENTIANA MACROPHYLLA A, H 2323 GENTIANA RHODANTHA A, H 2324 GENTIANA SCABRA A, H 2325 GENTIANELLA AMARELLA A, H 2326 GERANIAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2327 GERANIC ACID E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2328 GERANIOL E Permitted for use only: (a) in topical medicines for dermal application; and (b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. 2329 GERANIUM E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2330 GERANIUM MACULATUM A, E, H 2331 GERANIUM OIL A, E, H 2332 GERANIUM OIL SAPONIFIED E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2333 GERANIUM OIL TERPENELESS E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2334 GERANIUM ROBERTIANUM A, E, H 2335 GERANIUM ROSE OIL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2336 GERANIUM SIBIRICUM A, E, H 2337 GERANYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2338 GERANYL ACETONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2339 GERANYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2340 GERANYL CROTONATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2341 GERANYL ETHYL ETHER E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2342 GERANYL FORMATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2343 GERANYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2344 GERANYL ISOVALERATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2345 GERANYL NITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2346 GERANYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2347 GERANYL TIGLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2348 GEUM RIVALE A, H 2349 GEUM URBANUM A, H 2350 GHATTI GUM A, E, H 2351 GIGARTINA MAMILLOSA A, H Iodine is a mandatory component of Gigartina mamillosa. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 2352 GINGER DRY A, E, H 2353 GINGER OIL A, E, H 2354 GINGER OLEORESIN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in the medicine must be no more than 5%. 2355 GINGER POWDER A, E, H 2356 GINKGO BILOBA A, E, H The Ginkgo biloba leaf extract used in the manufacture of this medicine must comply with the requirement of Identification Test B of the monograph Powdered Ginkgo Extract in the United States Pharmacopeia 32 - National Formulary 27 (USP32-NF27), as in force or existing from time to time. This condition does not apply to powdered or dried leaf. 2357 GLACIAL ACETIC ACID E, H The concentration in the medicine must be no more than 1.5%. 2358 GLECHOMA HEDERACEA A, H 2359 GLECHOMA LONGITUBA A, H 2360 GLEDITSIA AUSTRALIS A, H 2361 GLEDITSIA SINENSIS A, H 2362 GLEHNIA LITTORALIS A, H 2363 GLORIOSA SUPERBA A, H Colchicine is a mandatory component of Gloriosa superba and must be declared in the application. The concentration of colchicine in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 2364 GLUCOMANNAN E Only for use when the dosage form is other than tablet. 2365 GLUCONOLACTONE E 2366 GLUCOSAMINE HYDROCHLORIDE A, E 2367 GLUCOSAMINE SULFATE A 2368 GLUCOSAMINE SULFATE POTASSIUM CHLORIDE A Potassium chloride is a mandatory component of glucosamine sulfate potassium chloride. When for oral use, only permitted in medicines containing less than 550 milligrams of potassium chloride per dosage unit or in preparations for oral rehydration therapy. When for oral use, the medicine requires the following warning statement on the medicine label: - (POTAS1) 'If you have kidney disease or are taking heart or blood pressure medicines - consult your doctor or pharmacist before use. Keep out of reach of children.' 2369 GLUCOSAMINE SULFATE SODIUM CHLORIDE A 2370 GLUCOSE A, E, H 2371 GLUCOSE GLUTAMATE E Only for use in topical medicines for dermal application. 2372 GLUCOSE MONOHYDRATE A, E, H 2373 GLUCOSYLRUTIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 2374 GLUTAMIC ACID A, E Only for use in topical medicines for dermal application. 2375 GLUTAMIC ACID HYDROCHLORIDE A, E, H 2376 GLUTAMINE A, E, H 2377 GLUTARAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2378 GLUTATHIONE A, E When used as an active ingredient, glutathione can only be used in medicines with an oral route of administration and must be indicated for use in adults only and not in pregnant or lactating women. The medicine requires the following warning statement on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect) - (ADULT) 'Adults only' (or words to that effect). 2379 GLUTEN-FREE WHEAT STARCH E 2380 GLYCERETH-26 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 7%. 2381 GLYCEROL A, E When used as an active ingredient, it is only for use in topical medicines for dermal application. 2382 GLYCEROL ESTER OF PARTIALLY HYDROGENATED GUM ROSIN E Only for use when the dosage form is 'chewing gum'. Must comply with: a) the Glycerol Ester of Partially Hydrogenated Gum Rosin monograph in the Food Chemicals Codex published by the United States Pharmacopeial Convention, as in force or existing from time to time; and b) the requirements for residual solvents and catalysts in the British Pharmacopoeia or the United States Pharmacopeia-National Formulary, as in force or existing from time to time. 2383 GLYCEROL ESTER OF PARTIALLY HYDROGENATED WOOD ROSIN E Glycerol ester of partially hydrogenated wood rosin must only be included in medicines when in combination with other permitted ingredients as a proprietary excipient formulation in medicines with a dermal route of administration for topical application. 2384 GLYCERYL BEHENATE E Behenic acid is a mandatory component of glyceryl behenate. When for oral ingestion, the maximum recommended daily dose must not provide more than 383.5 milligrams of behenic acid. In medicines for topical use, the concentration of glyceryl behenate must be no more than 5%. 2385 GLYCERYL CAPRYLATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 2386 GLYCERYL DIISOSTEARATE E For use in topical medicines for dermal application. 2387 GLYCERYL DILAURATE E Only for use in topical medicines for dermal application. 2388 GLYCERYL DIOLEATE E Only for use in topical medicines for dermal application. 2389 GLYCERYL DISTEARATE E Only for use in topical medicines for dermal application. 2390 GLYCERYL GLUCOSIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 2391 GLYCERYL ISOSTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5.5%. 2392 GLYCERYL LAURATE E Only for use in topical medicines for dermal application. 2393 GLYCERYL LINOLEATE E Only for use in topical medicines for dermal application. 2394 GLYCERYL LINOLENATE E Only for use in topical medicines for dermal application. 2395 GLYCERYL MONO AND DICAPRYLOCAPRATE E Only permitted for use in medicines limited to oral routes of administration, or when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The maximum recommended oral daily dose of the medicine must not provide more than 8 mg of glyceryl mono and dicaprylocaprate. The total concentration of fragrance proprietary excipient formulations containing glyceryl mono and dicaprylocaprate must not be more than 1% of the total medicine. 2396 GLYCERYL MONOOLEATE E 2397 GLYCERYL MONOSTEARATE E 2398 GLYCERYL MYRISTATE E Only for use in topical medicines for dermal application. 2399 GLYCERYL OLEATE CITRATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4% of the formulation. 2400 GLYCERYL PALMITO-STEARATE E 2401 GLYCERYL POLYACRYLATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.15%. 2402 GLYCERYL POLYMETHACRYLATE E Only for use in topical medicines for dermal application. 2403 GLYCERYL RICINOLEATE E Only for use in topical medicines for dermal application. 2404 GLYCERYL ROSINATE E Only for use when the dosage form is 'chewing gum'. Must comply with: a) the Glycerol Ester of Gum Rosin monograph in the Food Chemicals Codex published by the United States Pharmacopeial Convention, as in force or existing from time to time; and b) the requirements for residual solvents and catalysts in the British Pharmacopoeia or the United States Pharmacopeia National Formulary, as in force or existing from time to time. 2405 GLYCERYL SORBITAN OLEOSTEARATE E Only for use in topical medicines for dermal application. 2406 GLYCERYL STARCH E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 4%. The residual levels of epichlorohydrin are to be kept below the level of detection. 2407 GLYCERYL STEARATE CITRATE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%. 2408 GLYCERYL TRIACETYL HYDROXYSTEARATE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 6%. 2409 GLYCERYL TRIACETYL RICINOLEATE E Only for use in topical medicines for dermal application. 2410 GLYCERYL TRINITRATE H Only for use as an active homoeopathic ingredient. The total concentration of glyceryl trinitrate in the medicine must not be more than 100 micrograms/kg or 100 micrograms/L or 0.00001%. 2411 GLYCERYL UNDECYLENATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration of glyceryl undecylenate in a medicine must be no more than 3%. 2412 GLYCINE A, E 2413 GLYCINE MAX A, E, H 2414 GLYCOGEN E Only for use in topical medicines for dermal application. 2415 GLYCOL DISTEARATE E Only for use in topical medicines for dermal application. 2416 GLYCOLIC ACID E Only for use in topical medicines for dermal application. Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose. When present as an excipient in sunscreens, the concentration in the medicine must be no more than 5%. When used as an excipient ingredient in other medicines the concentration in the medicine must be no more than 20%. If the concentration is more than 5% but no more than 20%, the pH of the medicine must be 3.5 or greater. 2417 GLYCYRRHIZA GLABRA A, E, H 2418 GLYCYRRHIZA SPECIES E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2419 GLYCYRRHIZA URALENSIS A, E, H 2420 GLYCYRRHIZINIC ACID E 2421 GNAPHALIUM AFFINE A, H 2422 GNAPHALIUM POLYCEPHALUM A, H 2423 GNAPHALIUM ULIGINOSUM A, H 2424 GOAT H Only for use as an active homoeopathic ingredient. 2425 GOAT MILK E 2426 GOLD E, H Only for use as an active homoeopathic or excipient ingredient. 2427 GOLD CHLORIDE H Only for use as an active homoeopathic ingredient. 2428 GOLDEN ROD HERB DRY A, E, H 2429 GOLDEN SEAL ROOT DRY A, H 2430 GOLDEN SEAL ROOT POWDER A, H 2431 GOLDEN SYRUP E When the route of administration of the medicine is oral or sublingual, sucrose is a mandatory component of golden syrup. 2432 GOMPHRENA GLOBOSA A, H 2433 GOSSYPIUM HERBACEUM A, E, H 2434 GRAPE E 2435 GRAPE SEED OIL E 2436 GRAPE WINE RED E Ethanol is a mandatory component of grape wine red. 2437 GRAPE WINE SHERRY E Ethanol is a mandatory component of grape wine sherry. 2438 GRAPE WINE WHITE E Ethanol is a mandatory component of grape wine white. 2439 GRAPEFRUIT E 2440 GRAPEFRUIT OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2441 GRAPEFRUIT OIL COLDPRESSED A, E, H 2442 GRAPEFRUIT OIL CONCENTRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2443 GRAPEFRUIT OIL TERPENELESS E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2444 GRAPEFRUIT OIL TERPENES AND TERPENOIDS E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2445 GRAPHITE H Only for use as an active homoeopathic ingredient. 2446 GRATIOLA LINIFOLIA A, H 2447 GREATER NETTLE HERB DRY A, H 2448 GREATER NETTLE HERB POWDER A, H 2449 GREATER NETTLE ROOT DRY A, H 2450 GREATER NETTLE ROOT POWDER A, H 2451 GREEN LIPPED MUSSEL A The following warning statement is required on the medicine label: - (MOLLUSC) 'Contains mollusc' or 'Contains mollusc products'. 2452 GREEN LIPPED MUSSEL DRIED A The following warning statement is required on the medicine label: - (MOLLUSC) 'Contains mollusc' or 'Contains mollusc products'. 2453 GREEN LIPPED MUSSEL OIL A The following warning statement is required on the medicine label: - (MOLLUSC) 'Contains mollusc' or 'Contains mollusc products'. 2454 GREEN S E Only for use as a colour in topical and oral medicines. 2455 GRIFOLA FRONDOSA A When the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label: -(WARF) 'Do not take while on warfarin therapy without medical advice.' 2456 GRINDELIA CAMPORUM A, H 2457 GRINDELIA ROBUSTA A, H 2458 GRISALVA E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2459 GROUND IVY HERB DRY A, H 2460 GROUND IVY HERB POWDER A, H 2461 GUAIAC WOOD OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2462 GUAIACOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in the medicine must be no more than 5%. 2463 GUAIACUM OFFICINALE A, E, H 2464 GUAIACUM RESIN A, E, H 2465 GUAIACUM SANCTUM A, H 2466 GUAIENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2467 GUAIYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2468 GUANINE E Only for use as an excipient in topical medicines for dermal application. 2469 GUANOSINE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration must be no more than 0.01% in the medicine. 2470 GUAR GALACTOMANNAN A When for oral use: (a) the maximum daily dose must provide no more than 25 g of guar galactomannan; (b) the medicine requires the following dosage instructions: - (FIBRE) 'The dose of fibre should be increased gradually. Fluid intake should be increased with an increasing dose of fibre.' (or words to that effect) (c) when the dosage form is a powder preparation, the medicine requires the following dosage instructions: - (DNTPOW) 'Do not take powder alone. Mix with food or fluid.' (or words to that effect). 2471 GUAR GUM A, E, H 2472 GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE E Only for use as an excipient in topical medicines for dermal application. 2473 GUAREA RUSBYI A, H 2474 GUAVA E 2475 GURJUN BALSAM E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2476 GYMNADENIA NIGRA A 2477 GYMNEMA SYLVESTRE A, H 2478 GYMNOCLADUS DIOICA A, H 2479 GYNOSTEMMA PENTAPHYLLUM A The herbal substance must be derived from the aerial parts of the vine only (stem, leaves, fruit). 2480 HAHNEMANN'S SOLUBLE MERCURY H Only for use as an active homoeopathic ingredient. 2481 HALIBUT-LIVER OIL A, E Colecalciferol and Vitamin A are mandatory components of Halibut-liver oil. When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) 'WARNING: If you are pregnant - or considering becoming pregnant - do not take Vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].' NOTE: Position this warning at the beginning of the directions for use. - (VITA4) 'WARNING - When taken in excess of 3000 micrograms retinol equivalents - Vitamin A can cause birth defects.' NOTE: Position this warning at the beginning of the directions for use. - (VITA3) 'The recommended daily amount of Vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.' 2482 HAMAMELIS LEAF DRY A, H 2483 HAMAMELIS LEAF POWDER A, H 2484 HAMAMELIS VIRGINIANA A, E, H 2485 HAMAMELIS WATER A, E, H 2486 HANDROANTHUS HEPTAPHYLLUS A, H 2487 HANDROANTHUS IMPETIGINOSUS A, E, H 2488 HARD FAT E 2489 HARD PARAFFIN E 2490 HARICOT BEAN E 2491 HARPAGOPHYTUM PROCUMBENS A, E, H 2492 HARUNGANA MADAGASCARIENSIS A, H 2493 HAZEL NUT E 2494 HAZEL NUT OIL E 2495 HEAVY KAOLIN E 2496 HEAVY MAGNESIUM OXIDE A, E, H Magnesium is a mandatory component of heavy magnesium oxide. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 2497 HECTORITE E Only for use in topical medicines for dermal application. 2498 HEDEOMA PULEGIOIDES A 2499 HEDERA HELIX A, H Emetine is a mandatory component of Hedera helix. The concentration of emetine in the medicine must be no more than 0.2%. 2500 HEDTA E Only for use as an excipient in topical medicines for dermal application. 2501 HEKLA LAVA H Only for use as an active homoeopathic ingredient. 2502 HELESTRALIS E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2503 HELIANTHEMUM NUMMULARIUM A, H 2504 HELIANTHUS ANNUUS A, E, H 2505 HELIANTHUS TUBEROSUS A, H 2506 HELICHRYSUM ANGUSTIFOLIUM A, E, H 2507 HELICHRYSUM ARENARIUM A, H 2508 HELIOTROPYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2509 HELLEBORUS NIGER A, H The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material. 2510 HELLEBORUS VIRIDIS A, H The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material. 2511 HELONIAS RHIZOME DRY A, H 2512 HELONIAS RHIZOME POWDER A, H 2513 HEMIDESMUS INDICUS A, E, H 2514 HEMP SEED OIL A, E Cannabidiol and tetrahydrocannabinols are mandatory components of hemp seed oil. The total concentration of cannabidiol in hemp seed oil must not be more than 75 mg/kg. The total concentration of tetrahydrocannabinols in hemp seed oil must not be more than 10 mg/kg. The route of administration for medicines that contain hemp seed oil must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 36 g of hemp seed oil. The following warning statements (or words to that effect) are required on the medicine label: - 'Not for use in children under 2 years of age'; and - 'Not to be taken on the same day with other products containing hemp seed oil, including food sources'. 2515 HEPTANAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2516 HEPTANAL DIMETHYL ACETAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2517 HEPTANOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2518 HEPTENAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2519 HEPTYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2520 HEPTYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2521 HEPTYL UNDECYLENATE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration of the medicine must be no more than 25%. 2522 HERACLEUM HEMSLEYANUM A, H 2523 HERNIARIA GLABRA A, H 2524 HESPERIDIN A, E 2525 HESPEROCYPARIS MACROCARPA A, H 2526 HESPEROYUCCA WHIPPLEI A, H 2527 HEX-3-ENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2528 HEXAHYDRO-4,7-METHANOINDEN-6-YL PIVALATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2529 HEXAMETHYLINDANOPYRAN E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2530 HEXAN-1-OL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2531 HEXANE E The concentration of the medicine must be no more than 0.029%. When used for a route of administration other than topical, the residual solvent limit for Hexane is 2.9 mg per recommended daily dose. 2532 HEXANOATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2533 HEXANOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2534 HEXASODIUM FYTATE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration of Hexasodium fytate in the medicine must be no more than 1.0 %. 2535 HEXENAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2536 HEXYL 2-METHYLBUTYRATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2537 HEXYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2538 HEXYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2539 HEXYL CAPROATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2540 HEXYL FORMATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2541 HEXYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2542 HEXYL ISOVALERATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2543 HEXYL LAURATE E Only for use as an excipient in topical medicines for dermal application. 2544 HEXYL NICOTINATE E 2545 HEXYL PROPIONATE E Only for use in medicines in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must not be more than 5%. 2546 HEXYL SALICYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2547 HEXYL TIGLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2548 HEXYLDECANOL E Only for use as an excipient in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration of the medicine must be no more than 3%. 2549 HEXYLENE GLYCOL E Only for use as an excipient in topical medicines for dermal application. 2550 HEXYLRESORCINOL A Permitted for use only in medicated throat lozenges. The medicine of must not contain more than 2.5 mg of hexylresorcinol per lozenge. The maximum recommended daily dose of the medicine must not provide more than 30mg of hexylresorcinol. The medicine label must specify that the medicine is only to be used for 7 days (or less). The following warning statement must be included on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect). 2551 HIBISCUS ESCULENTUS A, H 2552 HIBISCUS MUTABILIS A, H 2553 HIBISCUS ROSA-SINENSIS E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2554 HIBISCUS SABDARIFFA A, E, H 2555 HIERACIUM PILOSELLA A, H 2556 HIGH AMYLOSE MAIZE STARCH A, E, H 2557 HIGH CHROMIUM YEAST A, E Chromium is a mandatory component of high chromium yeast. The maximum recommended daily dose must not provide more than 50 micrograms of chromium from organic chromium sources. High chromium yeast is considered to be an organic form of chromium. 2558 HIGH FRUCTOSE MAIZE SYRUP E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2559 HIGH MOLYBDENUM YEAST A, E Molybdenum is a mandatory component of high molybdenum yeast. The maximum daily dose of molybdenum from high molybdenum yeast must be no more than 62.5 micrograms. 2560 HIGH SELENIUM YEAST A When for oral or sublingual use, selenium is a mandatory component of high selenium yeast. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.' 2561 HIMATANTHUS LANCIFOLIUS A, E, H 2562 HIPPOPHAE RHAMNOIDES A, E, H 2563 HIRSCHFELDIA INCANA A, H Allyl isothiocyanate is a mandatory component of Hirschfeldia incana when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 2564 HISTAMINE DIHYDROCHLORIDE H Only for use as an active homoeopathic ingredient. 2565 HISTIDINE A 2566 HISTIDINE HYDROCHLORIDE A, E, H 2567 HO LEAF OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2568 HO WOOD OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2569 HOLCUS LANATUS A, H 2570 HOLY THISTLE HERB DRY A, H 2571 HOLY THISTLE HERB POWDER A, H 2572 HOMALOMENA OCCULTA A, H 2573 HOMOSALATE A, E For use as an active ingredient only in sunscreens for dermal application. For use as an excipient only in topical medicines for dermal application. Not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 15%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 2574 HONEY A, E When the route of administration is oral, the following warning statement is required on the medicine label: - (BABY2) 'Not suitable for infants under the age of twelve months' (or words to that effect). 2575 HONEY BEE H Only for use as an active homoeopathic ingredient. 2576 HONEY EXTRACT E Honey extract must not be included in medicines intended for use in the eye. The concentration of honey extract in the medicine must not be more than 1%. 2577 HONEY POWDER E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2578 HOP STROBILE DRY A, H 2579 HOP STROBILE POWDER A, H 2580 HOPS OIL A, E, H 2581 HORDEUM DISTICHON A, E, H Gluten is a mandatory component when the plant part is seed, and must be declared in the application when the route of administration is other than topical and mucosal. 2582 HORDEUM VULGARE A, E, H Gluten is a mandatory component when the plant part is seed, and must be declared in the application when the route of administration is other than topical and mucosal. 2583 HOREHOUND EXTRACT E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2584 HOTTONIA PALUSTRIS A, H 2585 HOUTTUYNIA CORDATA A, H 2586 HOVENIA DULCIS A, H 2587 HUMULUS LUPULUS A, E, H 2588 HYALURONIC ACID E Only for use as an excipient in topical medicines for dermal application. 2589 HYDNOCARPUS CASTANEUS A, H When the medicine is for other than topical use and the plant part is seed, the maximum recommended daily dose must be no more than 1mg of the equivalent dry seed. 2590 HYDRANGEA ARBORESCENS A, H 2591 HYDRANGEA PANICULATA A, H 2592 HYDRASTIS CANADENSIS A, E, H 2593 HYDRATED SILICA E Only for use when the route of administration is other than inhalation. 2594 HYDROCHLORIC ACID E The concentration of the medicine must be no more than 0.5%. 2595 HYDROCOTYLE UMBELLATA A, H 2596 HYDROGEN CYANIDE H Only for use as an active homoeopathic ingredient. 2597 HYDROGEN PEROXIDE A, E When used as the active ingredient, it is only for use in topical medicines for dermal application. The concentration of hydrogen peroxide in the medicine must be no more than 3%. When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 2598 HYDROGENATED BUTYLENE/ETHYLENE/STYRENE COPOLYMER E Only for use in topical medicines for dermal application. The combined concentration of hydrogenated butylene/ethylene/stryene copolymer and hydrogenated ethylene/propylene/styrene copolymer in the medicine must be no more than 9%. 2599 HYDROGENATED C6-14 OLEFIN POLYMERS E Only permitted for use in solid or semi-solid medicines for dermal application or in topical medicines for dermal application: (a) containing 25% or less of hydrocarbons, liquid; or (b) when packed in pressurised spray packs; or (c) when packed in containers with a capacity of 2 millilitres or less. Not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 7%. 2600 HYDROGENATED CASTOR OIL E 2601 HYDROGENATED COCO-GLYCERIDES E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. 2602 HYDROGENATED COCONUT OIL E 2603 HYDROGENATED COTTONSEED OIL E 2604 HYDROGENATED DIMER DILINOLEYL/DIMETHYLCARBONATE COPOLYMER E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 4% in the product. 2605 HYDROGENATED ETHYLENE/PROPYLENE/STYRENE COPOLYMER E The combined concentration of hydrogenated ethylene/propylene/styrene copolymer must be no more than 9%. 2606 HYDROGENATED LANOLIN E 2607 HYDROGENATED LECITHIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 2608 HYDROGENATED PALM GLYCERIDES E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.6%. 2609 HYDROGENATED PALM GLYCERIDES CITRATE E Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.01%. 2610 HYDROGENATED PALM KERNEL OIL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.2%. 2611 HYDROGENATED PALM OIL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. Polycyclic aromatic hydrocarbons must be kept below the level of detection. 2612 HYDROGENATED POLYDECENE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. 2613 HYDROGENATED POLYDEXTROSE A Only permitted for use in medicines: (a) limited to oral routes of administration; and (b) when the maximum recommended daily dose does not provide more than 15 g of hydrogenated polydextrose. 2614 HYDROGENATED POLYISOBUTENE E Only for use in topical medicines for dermal application. 2615 HYDROGENATED SOYA OIL E 2616 HYDROGENATED TALLOW GLYCERIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. 2617 HYDROGENATED VEGETABLE OIL E 2618 HYDROLIAC E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2619 HYDROLYSED ADANSONIA DIGITATA LEAF POLYSACCHARIDES E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 0.01% 2620 HYDROLYSED ALGIN E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 0.02% 2621 HYDROLYSED CEREAL SOLIDS E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2622 HYDROLYSED CHICKEN CARTILAGE EXTRACT A The route of administration for medicines that contain hydrolysed chicken cartilage extract must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 2000 mg hydrolysed chicken cartilage extract. The following warning statement (or words to the same effect) is required on the medicine label: - (ADULT) 'Adults only'. 2623 HYDROLYSED COLLAGEN A, E 2624 HYDROLYSED ELASTIN E Only for use in topical medicines for dermal application. 2625 HYDROLYSED GELATIN A, E 2626 HYDROLYSED GLYCOSAMINOGLYCANS E Only for use in topical medicines for dermal application. 2627 HYDROLYSED JOJOBA ESTERS E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 2628 HYDROLYSED KERATIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 2629 HYDROLYSED MAIZE STARCH E 2630 HYDROLYSED MILK PROTEIN E 2631 HYDROLYSED RICE A, E, H 2632 HYDROLYSED RICE PROTEIN E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 0.125%. 2633 HYDROLYSED SOY PROTEIN E Only for use in topical medicines for dermal application not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 2634 HYDROLYSED VEGETABLE PROTEIN E 2635 HYDROLYSED WHEAT PROTEIN E Gluten is a mandatory component of hydrolysed wheat protein. 2636 HYDROLYSED WHEAT PROTEIN/PVP CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 1.2%. 2637 HYDROLYSED YEAST PROTEIN E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.3%. 2638 HYDROQUINONE DIMETHYL ETHER E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2639 HYDROUS WOOL FAT A, E When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 2640 HYDROXOCOBALAMIN A 2641 HYDROXYACETOPHENONE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 1%. 2642 HYDROXYAPATITE A, E 2643 HYDROXYCITRATE COMPLEX A The requirements specified in paragraph (a) below applies to a medicine that contains the ingredient that is: - listed in the Register before 1 March 2025; and - released for supply before 1 March 2026: (a) Hydroxycitrate complex must contain one or more of the three salts (calcium, sodium or potassium hydroxycitrate) of hydroxycitric acid. The requirements specified in paragraphs (b) to (d) below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. (b) Hydroxycitrate complex must contain one or more of the three salts (calcium, sodium or potassium hydroxycitrate) of hydroxycitric acid. (c) When for oral use, the following warning statement is required on the medicine label: 'In very rare cases, hydroxycitrate complex may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.' (d) Medicines containing hydroxycitrate complex must not be directed for use in children, or in pregnant or lactating women. 2644 HYDROXYCITRIC ACID A The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. When for oral use, the following warning statement is required on the medicine label: 'In very rare cases, hydroxycitric acid may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.' Medicines containing hydroxycitric acid must not be directed for use in children, or in pregnant or lactating women. 2645 HYDROXYCITRONELLAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2646 HYDROXYCITRONELLAL DIMETHYL ACETAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2647 HYDROXYCITRONELLAL-METHYLANTHRANILATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2648 HYDROXYCITRONELLOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2649 HYDROXYETHYL CETEARAMIDOPROPYLDIMONIUM CHLORIDE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 2650 HYDROXYETHYL UREA E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration must be no more than 1%. 2651 HYDROXYLATED LANOLIN E 2652 HYDROXYLATED MILK GLYCERIDES E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration must be no more than 0.1%. 2653 HYDROXYLYSINE A, E 2654 HYDROXYMETHYLCELLULOSE E 2655 HYDROXYOCTACOSANYL HYDROXYSTEARATE E Only for use in topical medicines for dermal application. 2656 HYDROXYPALMITOYL SPHINGANINE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration must be no more than 0.1%. 2657 HYDROXYPROLINE A, E 2658 HYDROXYPROPYL DISTARCH PHOSPHATE E Only permitted for: - use in topical medicines for dermal application; and - medicines for internal use. When for use in topical medicines for dermal application: - not to be included medicines intended for use in the eye or damaged skin; and - the concentration of hydroxypropyl distarch phosphate in the medicine must be no more than 4%. When for internal use, the maximum recommended daily dose must not contain more than 240mg of hydroxypropyl distarch phosphate. 2659 HYDROXYPROPYL STARCH E 2660 HYDROXYPROPYLBETADEX E Only for use in topical medicines for dermal application. 2661 HYDROXYSTEARIC ACID E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration must be no more than 9%. 2662 HYETELLOSE E 2663 HYLOCEREUS LEMAIREI E Permitted for use only as a colour for oral and topical use. 2664 HYLOCEREUS UNDATUS A, H 2665 HYMETELLOSE E 2666 HYOSCYAMUS LEAF DRY A, H Alkaloids calculated as hyoscyamine and hyoscine are mandatory components of Hyoscamus leaf dry. The concentration of alkaloids calculated as hyoscyamine in the medicine must not be more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. The concentration of hyoscine in the medicine must not be more than 300 micrograms/kg or 300 micrograms/L or 0.00003%. 2667 HYOSCYAMUS LEAF POWDER A, H Alkaloids calculated as hyoscyamine and hyoscine are mandatory components of Hyoscamus leaf powder. The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. The concentration of hyoscine in the medicine must be no more than 300 micrograms/kg or 300 micrograms/L or 0.00003%. 2668 HYOSCYAMUS NIGER A, H Alkaloids calculated as hyoscyamine and hyoscine are mandatory components of Hyoscyamus niger. The concentration of hyoscyamine in the medicine must be no more than 3 micrograms/kg or 3 micrograms/L or 0.3%. The concentration of hyoscine in the medicine must be no more than 300 micrograms/kg or 300 micrograms/L or 0.00003%. 2669 HYPERICUM ASCYRON A, H 2670 HYPERICUM JAPONICUM A, H 2671 HYPERICUM PERFORATUM A, E, H When used for oral ingestion, the medicine requires the following warning statement on the medicine label: - (STJOHN) 'St John's Wort affects the way many prescription medicines work - including oral contraceptives. Consult your doctor.' 2672 HYPROLOSE E 2673 HYPROMELLOSE E 2674 HYPROMELLOSE PHTHALATE E 2675 HYPTIS SUAVEOLENS A, H 2676 HYSSOPUS OFFICINALIS A, E, H 2677 IBERIS AMARA A, H 2678 ICHTHAMMOL H Only for use as an active homoeopathic ingredient. 2679 ILEX AQUIFOLIUM A, H 2680 ILEX CHINENSIS A, H 2681 ILEX PARAGUARIENSIS A, E, H Caffeine is a mandatory component of Ilex paraguariensis. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: - (ADULT) 'Adults only' (or words to that effect). - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.' - (CAFFPREG) 'Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.' When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.' - (CAFFCYP) 'Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines' (or words to that effect). 2682 ILEX ROTUNDA A, H 2683 ILEX VERTICILLATA A, H 2684 ILLICIUM VERUM A, H When the plant preparation is oil or distillate, and the concentration of Illicium verum oil or distillate in the preparation is greater than 50%: (a) the nominal capacity of the container must not be more than 50 millilitres; (b) a restricted flow insert must be fitted on the container; and (c) the following warning statement is required on the label: - (CHILD) 'Keep out of reach of children' (or words to that effect). 2685 IMIDUREA E Only for use in topical medicines for dermal application. 2686 IMMORTELLE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2687 IMMORTELLE OIL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2688 IMPATIENS E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2689 IMPATIENS BALSAMINA A, H 2690 IMPATIENS GLANDULIFERA A, H 2691 IMPERATA CYLINDRICA A, E, H 2692 INDIGO CARMINE E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 2693 INDIGO CARMINE ALUMINIUM LAKE E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 2694 INDIGOFERA TINCTORIA A, H 2695 INDISAN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2696 INDOLE E, H Only for use as an active homoeopathic or excipient ingredient. The maximum recommended daily dose must contain no more than 75 mg indole. 2697 INDOLENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2698 INDUSTRIAL METHYLATED SPIRIT E 2699 INOSITOL A, E 2700 INULA BRITANNICA A, H 2701 INULA HELENIUM A, E, H 2702 INULA RACEMOSA A, H 2703 INULIN A, E 2704 INULIN LAURYL CARBAMATE E Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 1.2%. 2705 INVERT SUGAR E 2706 INVERT SYRUP E When the route of administration is oral or sublingual, glucose is a mandatory component of Invert syrup. 2707 IODINE H Only for use as an active homoeopathic ingredient. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 2708 IODOPROPYNYL BUTYLCARBAMATE E For use as an excipient ingredient in topical medicines only. The concentration in aqueous medicines must be no more than 10%. 2709 IONONE E Permitted for use only: (a) in topical medicines for dermal application; and (b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. 2710 IOPAMIDOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2711 IPECACUANHA DRY A, H Emetine is a mandatory component of Ipecacuanha Dry. The concentration of emetine in the medicine must be no more than 0.2%. 2712 IPECACUANHA POWDER A, H Emetine is a mandatory component of Ipecacuanha Powder. The concentration of emetine in the medicine must be no more than 0.2%. 2713 IPECACUANHA PREPARED A, H Emetine is a mandatory component of Ipecacuanha Prepared. The concentration of emetine in the medicine must be no more than 0.2%. 2714 IPECACUANHA ROOT LIQUID EXTRACT A, H Emetine is a mandatory component of Ipecacuanha root liquid extract. The concentration of emetine in the medicine must be no more than 0.2%. 2715 IPOMOEA BATATAS A, H 2716 IPOMOEA JALAPA A, H 2717 IRIDOPHYCUS FLACCIDUM A, H Iodine is a mandatory component of Iridophycus flaccidum. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is more than 2.5%. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 2718 IRIS DOMESTICA A, H 2719 IRIS FLORENTINA A, H 2720 IRIS GERMANICA A, H 2721 IRIS PALLIDA A, H 2722 IRIS TENAX H 2723 IRIS VERSICOLOR A, H 2724 IRON A, H Only for use in oral medicines. When used as an active ingredient, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the following warning statement is required on the label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2725 IRON (II) BISGLYCINE SULFATE TRIHYDRATE A Only for use in oral medicines. Iron is a mandatory component of iron (II) bisglycine sulfate trihydrate. When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the following warning statement is required on the label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2726 IRON (II) GLYCINATE A Only for use in oral medicines. Iron is a mandatory component of iron (II) glycinate. When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the following warning statement is required on the label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2727 IRON (III) GLYCINATE A Only for use in oral medicines. Iron is a mandatory component of iron (III) glycinate. When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the following warning statement is required on the label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2728 IRON AMINO ACID CHELATE A, H Only for use in oral medicines. When used internally, iron is a mandatory component of iron amino acid chelate. The concentration of iron in iron amino acid chelate must be no more than 25%. When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the following warning statement is required on the label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2729 IRON OXIDE BLACK E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. When used in undivided preparations for internal use and the concentration of iron oxide in the medicine is more than 1%, it is considered part of the total iron content. When used in divided preparations for internal use, the concentration in the medicine must be no more than 10 mg per dosage unit. 2730 IRON OXIDE RED E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. When used in undivided preparations for internal use and the concentration of iron oxide in the medicine is more than 1%, it is considered part of the total iron content. When used in divided preparations for internal use, the concentration in the medicine must be no more than 10 mg per dosage unit. 2731 IRON OXIDE YELLOW E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. When used in undivided preparations for internal use and the concentration of iron oxide in the medicine is more than 1%, it is considered part of the total iron content. When used in divided preparations for internal use, the concentration in the medicine must be no more than 10 mg per dosage unit. 2732 IRON PHOSPHATE A, E, H When used internally, iron is a mandatory component of iron phosphate and must be declared. When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron. In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%). Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure. When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the following warning statement is required on the label: - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect). 2733 IRONE E 2734 IRVINGIA GABONENSIS SEED TRIGLYCERIDES E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration must be no more than 0.375%. 2735 ISATIS TINCTORIA A, H 2736 ISOAMBRETTOLIDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2737 ISOAMYL 2-METHYLBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2738 ISOAMYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2739 ISOAMYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2740 ISOAMYL BENZOATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2741 ISOAMYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2742 ISOAMYL CAPRYLATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2743 ISOAMYL CINNAMATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2744 ISOAMYL CITRONELLYL KETONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2745 ISOAMYL FORMATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2746 ISOAMYL HEXANOATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2747 ISOAMYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2748 ISOAMYL ISOVALERATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2749 ISOAMYL LAURATE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration must be no more than 12%. 2750 ISOAMYL METHOXYCINNAMATE A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 2751 ISOAMYL PHENYLACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2752 ISOAMYL PHENYLETHYL ETHER E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 2753 ISOAMYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2754 ISOAMYL SALICYLATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2755 ISOBERGAMIATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2756 ISOBORNEOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2757 ISOBORNYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2758 ISOBORNYL CYCLOHEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2759 ISOBUTANE E Only for use in topical medicines for dermal application. 2760 ISOBUTYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2761 ISOBUTYL ALCOHOL E The residual solvent limit for Isobutyl alcohol is 50mg per recommended daily dose. The concentration of isobutyl alcohol must be no more than 0.5% of the formulation. 2762 ISOBUTYL BENZOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. 2763 ISOBUTYL BENZYL CARBINOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. 2764 ISOBUTYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2765 ISOBUTYL CAPROATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2766 ISOBUTYL CINNAMATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2767 ISOBUTYL FORMATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2768 ISOBUTYL HYDROXYBENZOATE E Only for use in topical medicines for dermal application. 2769 ISOBUTYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2770 ISOBUTYL ISOVALERATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2771 ISOBUTYL PHENYLACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2772 ISOBUTYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2773 ISOBUTYL QUINOLINE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2774 ISOBUTYL SALICYLATE E Only for use in topical medicines for dermal application. 2775 ISOBUTYLENE/ISOPRENE COPOLYMER E Only for oral use when the dosage form is chewing gum. The concentration must be consistent with best practice for the production of gum delivery systems. 2776 ISOBUTYRALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2777 ISOBUTYRIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2778 ISOCETYL ALCOHOL E Only for use in topical medicines for dermal application. 2779 ISOCETYL LINOLEOYL STEARATE E Only for use in topical medicines for dermal application. 2780 ISOCETYL STEARATE E Only for use in topical medicines for dermal application. 2781 ISOCETYL STEAROYL STEARATE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration must be no more than 10%. 2782 ISOCYCLOCITRAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2783 ISODECYL ISONONANOATE E Only for use in topical medicines for dermal application. 2784 ISODECYL NEOPENTANOATE E Only for use in topical medicines for dermal application. 2785 ISODECYL OLEATE E Only for use in topical medicines for dermal application. 2786 ISODECYL SALICYLATE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration must be no more than 2%. 2787 ISODODECANE E Only for use in topical medicines for dermal application. 2788 ISOEICOSANE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration must be no more than 2%. 2789 ISOEUGENOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. When the medicine is for dermal use, the total concentration of isoeugenol in the medicine must not be more than 0.02%. 2790 ISOEUGENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2791 ISOEUGENYL BENZYL ETHER E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2792 ISOHEXADECANE E Only for use in topical medicines for dermal application. 2793 ISOJASMONE E Permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation or fragrance proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must not be more than 5%. The total fragrance proprietary excipient formulation in a medicine must not be more 1%. 2794 ISOLEUCINE A, E 2795 ISOMALT E 2796 ISOMENTHONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2797 ISOMETHYLIONONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2798 ISONONYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used as in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2799 ISONONYL ISONONANOATE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration must be no more than 15%. 2800 ISOPENTANE E For dental use only. The concentration must be no more than 2%. 2801 ISOPENTANOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2802 ISOPHORONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. The total concentration of isophorone in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 2803 ISOPHYTOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2804 ISOPROPYL 2-METHYLBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2805 ISOPROPYL 4-HYDROXYBENZOATE E Only for use in topical medicines for dermal application. 2806 ISOPROPYL ACETATE E Only for use in topical medicines for dermal application. 2807 ISOPROPYL ALCOHOL E 2808 ISOPROPYL CAPROATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2809 ISOPROPYL CINNAMATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2810 ISOPROPYL ISOSTEARATE E Only for use in topical medicines for dermal application. 2811 ISOPROPYL LANOLATE E Only for use in topical medicines for dermal application. 2812 ISOPROPYL LAUROYL SARCOSINATE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration must be no more than 5.6%. 2813 ISOPROPYL MYRISTATE E 2814 ISOPROPYL PALMITATE E Only for use in topical medicines for dermal application. 2815 ISOPROPYL PPG-2 ISODECETH-7 CARBOXYLATE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration must be no more than 10%. 2816 ISOPROPYL STEARATE E Only for use in topical medicines for dermal application. 2817 ISOPROPYL TITANIUM TRIISOSTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration must be no more than 0.2%. 2818 ISOPROPYL-3-METHYL-BUTANE THIOATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2819 ISOPULEGOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2820 ISORALDEINE 70 E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2821 ISOSTEARIC ACID E Only for use in topical medicines for dermal application. 2822 ISOSTEAROYL HYDROLYSED COLLAGEN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration must be no more than 0.3%. 2823 ISOSTEARYL ALCOHOL E Only for use in topical medicines for dermal application. 2824 ISOSTEARYL NEOPENTANOATE E Only for use in topical medicines for dermal application. 2825 ISOSTEARYL PALMITATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration must be no more than 2%. 2826 ISOTRIDECYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2827 ISOVALERALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2828 ISOVALERIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2829 ISPAGHULA HUSK DRY A, H When a dose for children is stated, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect). 2830 ISPAGHULA HUSK POWDER A, H When a dose for children is stated, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect). 2831 IVA AXILLARIS A, H 2832 JAMAICA DOGWOOD BARK DRY A, H 2833 JAMAICA DOGWOOD BARK POWDER A, H 2834 JASMINE ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2835 JASMINE LACTONE E Only for use in topical medicines for dermal application. 2836 JASMINE OIL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2837 JASMINUM GRANDIFLORUM E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2838 JASMINUM OFFICINALE A, E, H 2839 JASSOLIA E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2840 JATEORHIZA PALMATA A, H 2841 JATROPHA CURCAS H Only for use as an active homoeopathic ingredient 2842 JERUSALEM ARTICHOKE E 2843 JOJOBA ESTERS E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 25%. 2844 JUGLANS CINEREA A, E, H 2845 JUGLANS NIGRA A, E, H 2846 JUGLANS REGIA A, H 2847 JUNCUS EFFUSUS A, H 2848 JUNIPER BERRY OIL A, E, H 2849 JUNIPER BERRY OIL TERPENELESS E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2850 JUNIPERUS CALIFORNICA A, H 2851 JUNIPERUS COMMUNIS A, E, H 2852 JUNIPERUS DEPPEANA E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2853 JUNIPERUS OXYCEDRUS A, H 2854 JUNIPERUS VIRGINIANA A, E, H 2855 JUSTICIA ADHATODA A, H Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine Note: See sections 5 and 6. Permissible ingredients and requirements Column 1 Column 2 Column 3 Column 4 Item Ingredient name Purpose Specific requirements 2856 KADSURA COCCINEA A, H 2857 KAEMPFERIA GALANGA A, H 2858 KALMIA LATIFOLIA A, H Beta-arbutin is a mandatory component of Kalmia latifolia. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 2859 KAOLIN E 2860 KELP DRY A, H Iodine is a mandatory component of Kelp dry. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 2861 KELP POWDER A, E, H Iodine is a mandatory component of Kelp powder. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 2862 KERATIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 2863 KEROSENE E, H Only for use as a homoeopathic ingredient. When used in liquid preparations, the concentration in the medicine must be no more than 25%. 2864 KHAYA SENEGALENSIS A, E The maximum daily dose of the medicine must not contain more than the equivalent of 1 g dry bark of Khaya senegalensis. The following warning statements are required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); - (LONGUSE) 'Not for prolonged use. May harm liver'; - (GEN2) 'If symptoms persist, seek the advice of a healthcare professional'; - (CHILD3) 'Use in children under 12 years is not recommended'; and - (7DAYS) 'Do not use for more than 7 days'. 2865 KIDNEY BEAN E 2866 KIRSCH E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2867 KIWI FRUIT E 2868 KNAUTIA ARVENSIS A, H 2869 KOREAN GINSENG ROOT DRY A, H 2870 KOREAN GINSENG ROOT POWDER A, H 2871 KRAMERIA IXINE A, H 2872 KRAMERIA LAPPACEA A, H 2873 KUNZEA AMBIGUA A Only for use when the plant preparation is essential oil. Only for use when the route of administration is topical or inhalation. When the dosage form is essential oil, a restricted flow insert must be fitted on the container and the medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' - (EXTERN) 'For external use only' - (UNDILU) 'Not to be applied undiluted to the skin except on the advice of a health care practitioner'. When the dosage form is other than essential oil, the maximum concentration in topical medicines must be no more than 25% w/w and the medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' - (EXTERN) 'For external use only'. 2874 L-BORNEOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2875 L-BORNYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used as in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2876 L-CARVONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2877 L-LIMONENE E L-limonene must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation or a fragrance proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing l-limonene must not be more than 5% of the total medicine. The total concentration of fragrance proprietary excipient formulations containing l-limonene must not be more than 1% of the total medicine. 2878 L-LINALOOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 2879 L-MENTHONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2880 L-MENTHYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2881 L-ROSE OXIDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2882 LABDANUM ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2883 LABDANUM GUM EXTRACT ETHYL ESTER E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance and the total fragrance concentration in a medicine is no more than 1%. 2884 LABDANUM OIL A, E, H 2885 LABURNUM ANAGYROIDES A, H Sparteine is a mandatory component of Laburnum anagyroides. The concentration of sparteine in the medicine must be no more than 0.001%. 2886 LACTALBUMIN E 2887 LACTIC ACID A, E, H When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing form time to time. Sponsors should consider the impact of excipients containing alpha hydroxy acids on the sensitivity of the skin to sunlight and should ensure the finished medicine is safe for its intended purpose. 2888 LACTITOL E 2889 LACTITOL MONOHYDRATE E 2890 LACTO-N-NEOTETRAOSE A Lactose is a mandatory component of lacto-N-neotetraose. The route of administration for medicines that contain lacto-N-neotetraose must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than: (a) 1.5 g of lacto-N-neotetraose to individuals aged 4 years and older; and (b) 0.6 g of lacto-N-neotetraose to individuals aged up to 3 years (inclusive). One of the following statements (or words to the same effect) is required on the medicine label: (a) When the medicine is only for use in individuals aged 2 years and above: 'Not to be taken on the same day with other products containing lacto-N-neotetraose'; or (b) When the medicine is for use in children aged less than 2 years: 'Not to be taken on the same day with breastmilk or other products containing lacto-N-neotetraose'. 2891 LACTO-N-TETRAOSE A Lactose is a mandatory component of lacto-N-tetraose. The route of administration for medicines that contain lacto-N-tetraose must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than: a) 2 g of lacto-N-tetraose to individuals aged 1 year and older; and b) 0.6 g of lacto-N-tetraose to individuals aged more than 6 months to 11 months (inclusive); and c) 0.8 g of lacto-N-tetraose to individuals aged up to 6 months (inclusive). One of the following statements (or words to the same effect) is required on the medicine label: a) When the medicine is only for use in individuals aged 2 years and above: 'Not to be taken on the same day with other products containing lacto-N-tetraose'; or b) When the medicine is for use in children aged less than 2 years: 'Not to be taken on the same day with breastmilk or other products containing lacto-N-tetraose'. 2892 LACTOBACILLUS ACIDOPHILUS A 2893 LACTOBACILLUS AMYLOVORUS A 2894 LACTOBACILLUS BREVIS A 2895 LACTOBACILLUS CASEI A 2896 LACTOBACILLUS CASEI SUBSP. BIOVAR CASEI A 2897 LACTOBACILLUS CRISPATUS A 2898 LACTOBACILLUS DELBRUECKII SSP BULGARICUS A 2899 LACTOBACILLUS DELBRUECKII SSP LACTIS A 2900 LACTOBACILLUS FERMENTUM A 2901 LACTOBACILLUS GALLINARUM A 2902 LACTOBACILLUS GASSERI A 2903 LACTOBACILLUS HELVETICUS A 2904 LACTOBACILLUS JOHNSONII A 2905 LACTOBACILLUS KEFIRANOFACIENS A 2906 LACTOBACILLUS KEFIRGRANUM A 2907 LACTOBACILLUS KEFIRI A 2908 LACTOBACILLUS PARACASEI A 2909 LACTOBACILLUS PARACASEI SUBSP. PARACASEI A 2910 LACTOBACILLUS PLANTARUM A 2911 LACTOBACILLUS REUTERI A 2912 LACTOBACILLUS RHAMNOSUS A 2913 LACTOBACILLUS SALIVARIUS SSP SALICINIUS A 2914 LACTOBACILLUS SALIVARIUS SSP SALIVARIUS A 2915 LACTOBIONIC ACID E Only for use in topical medicines for dermal application. 2916 LACTOSCATONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2917 LACTOSE E 2918 LACTOSE MONOHYDRATE E 2919 LACTUCA SATIVA A, H 2920 LACTUCA VIROSA A, H 2921 LACTULOSE E 2922 LACTULOSE SOLUTION A When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing form time to time. 2923 LAGENARIA VULGARIS A, H 2924 LAMINARIA CLOUSTONI A, E, H Iodine is a mandatory component of Laminaria cloustoni. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 2925 LAMINARIA DIGITATA A, E, H Iodine is a mandatory component of Laminaria digitata. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 2926 LAMINARIA JAPONICA A, E, H Iodine is a mandatory component of Laminaria japonica. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 2927 LAMIUM ALBUM A, H 2928 LANETH-5 E Only for use in topical medicines for dermal application. 2929 LANOLIN ALCOHOL E Only for use in topical medicines for dermal application. 2930 LANOLIN OIL E Only for use in topical medicines for dermal application. 2931 LANOLIN WAX E Only for use in topical medicines for dermal application. 2932 LANTANA CAMARA A, H The maximum recommended daily dose must contain no more than 1mg of the equivalent dry herbal material of Lantana camara. 2933 LARIX ARABINOGALACTAN A, E The concentration of polysaccharides in the ingredient must be greater than or equal to 85%. The ingredient must be derived from Larix occidentalis or Larix larcinia. Only for use in oral medicines or topical medicines for dermal application, and not to be included in topical products intended for use in the eye. The maximum recommended daily dose of Larix arabinogalactan in oral medicines must not be more than 15 grams. The concentration of Larix arabinogalactan in topical medicines for dermal application must not exceed 5.0%. 2934 LARIX DECIDUA A, H 2935 LARIX KAEMPFERI A, H The maximum recommended daily dose must be no more than 1 mg of the equivalent dry herbal material of Larix kaempferi. 2936 LARREA TRIDENTATA A, H The following warning statement is required on the medicine label: (CHAP1) 'In rare cases, Larrea tridentata may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine.' 2937 LATHYRUS SATIVUS A, H The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Lathyrus sativus. The medicine must not contain lathyrogenic amino acids. 2938 LAURAMINE OXIDE E 2939 LAUREL LEAF OIL A, H When the total concentration of bay oil in the medicine is more than 25%: (a) the nominal capacity of the container must not be more than 25 mL; (b) the container must be fitted with a restricted flow insert; (c) the following warning statements are required on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and (d) when the nominal capacity of the container is greater than 15 mL, the container must also be fitted with a child resistant closure. 2940 LAURETH-10 E Only for use in topical medicines for dermal application. 2941 LAURETH-12 E Only for use in topical medicines for dermal application. 2942 LAURETH-2 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.4%. Residual levels of ethylene oxide (and related substances) must be kept below the level of detection. 2943 LAURETH-23 E Only for use in topical medicines for dermal application. 2944 LAURETH-3 E Only for use in topical medicines for dermal application. 2945 LAURETH-4 E Only for use in topical medicines for dermal application. 2946 LAURETH-7 E Only for use in topical medicines for dermal application. 2947 LAURETH-8 E 2948 LAURIC ACID A, E When for use as an active ingredient is for use in oral medicines only and the maximum recommended daily dose must not exceed 1500 mg. 2949 LAURIL MACROGOL 400 DIMETICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 5%. 2950 LAUROMACROGOL 400 E Only for use in topical medicines for dermal application. 2951 LAUROYL LYSINE E Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 5.0%. 2952 LAURUS NOBILIS A, E, H When the plant preparation is oil or distillate, and the concentration of bay oil or distillate in the medicine is greater than 25%: (a) the nominal capacity of the container must not be more than 25 mL; (b) the container must be fitted with a restricted flow insert; (c) the following warning statements are required on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and (d) when the nominal capacity of the container is greater than 15 mL, the container must also be fitted with a child resistant closure. 2953 LAURYL ALDEHYDE E Permitted for use only in combination with other permitted ingredients as a coating solution, flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2954 LAURYL BETAINE E Only for use in topical medicines for dermal application. 2955 LAURYL GLUCOSIDE E Only for use as an excipient ingredient in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 12%. 2956 LAURYL LACTATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. Sponsors should consider the impact of excipients containing alpha hydroxy acids on the sensitivity of the skin to sunlight and should ensure the finished medicine is safe for its intended purpose. 2957 LAURYL PCA E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 2958 LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. 2959 LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or damaged skin. The concentration in the medicine must be no more than 3.5%. 2960 LAURYL PEG/PPG-18/18 METHICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 9%. Residual levels of ethylene oxide (and related substances) must be kept below the level of detection. 2961 LAURYL POLYGLUCOSE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration must not exceed 1% in leave-on medicines and 3% in wash-on/wash-off medicines. 2962 LAURYL PYRROLIDONE E Only for use in topical medicines for dermal application. 2963 LAURYLDIMONIUM HYDROXYPROPYL HYDROLYSED COLLAGEN E Only for use in topical medicines for dermal application. 2964 LAURYLDIMONIUM HYDROXYPROPYL HYDROLYSED SOY PROTEIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.007%. 2965 LAURYLMETICONE COPOLYOL E Only for use in topical medicines for dermal application. 2966 LAVANDIN OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2967 LAVANDIN OIL ABRIAL A, E, H 2968 LAVANDIN OIL GROSSO E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 2969 LAVANDULA ANGUSTIFOLIA A, E, H Camphor is a mandatory component of Lavandula angustifolia. In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%. In liquid preparations other than essential oils or distillates, the concentration of camphor must be no more than 2.5%. 2970 LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA A, E, H Camphor is a mandatory component of Lavandula angustifolia subsp. angustifolia. In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%. In liquid preparations other than essential oils or distillates, the concentration of camphor must be no more than 2.5%. 2971 LAVANDULA X INTERMEDIA A, E, H Camphor is a mandatory component of Lavandula x intermedia. In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%. 2972 LAVENDER OIL A, E, H 2973 LAWSONIA INERMIS A, H 2974 LEAD H Only for use as an active homoeopathic ingredient. The concentration in the medicine must be no more than 0.001%. 2975 LEAD ACETATE H Only for use as an active homoeopathic ingredient. 2976 LEAF ACETAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. 2977 LECITHIN A, E 2978 LEDEBOURIELLA SESELOIDES A, H 2979 LEDUM PALUSTRE A, H Beta-arbutin is a mandatory component of Ledum palustre. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for topical use other than dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. When the route of administration is other than topical, the maximum recommended daily dose must not contain more than 0.001 mg of the equivalent dry herbal material of Ledum palustre. 2980 LEMNA MINOR A, H 2981 LEMON E When used internally, oxedrine is a mandatory component of lemon. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. 2982 LEMON BALM LEAF DRY A, H 2983 LEMON BALM LEAF POWDER A, E, H 2984 LEMON OIL A, E, H When used internally, oxedrine is a mandatory component of lemon oil. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. The warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) steam distilled or rectified; or b) for internal use; or c) contains 0.05% or less of lemon oil; or d) for use in soaps or bath or shower gels that are washed off the skin. 2985 LEMON OIL DISTILLED A, E, H When used internally, oxedrine is a mandatory component of lemon oil distilled. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. 2986 LEMON OIL TERPENELESS A, E, H When used internally, oxedrine is a mandatory component of lemon oil terpeneless. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. 2987 LEMON OIL TERPENES AND TERPENOIDS E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 2988 LEMON PEEL DRIED A, E, H When used internally, oxedrine is a mandatory component of lemon peel dried. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. 2989 LEMONGRASS OIL A, E, H 2990 LENS CULINARIS A, H 2991 LENTIL E 2992 LENTINULA EDODES A, E, H 2993 LEONTOPODIUM ALPINUM E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 2994 LEONURUS CARDIACA A, E, H 2995 LEONURUS SIBIRICUS A, E, H 2996 LEPIDIUM APETALUM A, H 2997 LEPIDIUM MEYENII A The route of administration for medicines that contain Lepidium meyenii must be limited to oral. The ingredient must consist of the dried tuber of Lepidium meyenii only. The maximum recommended daily dose of the medicine must not provide more than 3.5 g of Lepidium meyenii dried tuber (or its extract equivalent). 2998 LEPTOSPERMUM PETERSONII E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more 5%. 2999 LEPTOSPERMUM SCOPARIUM OIL A Only for use as an active ingredient when the route of administration is oral application in a mouthwash, or topical. If the concentration is more than 25%, the nominal capacity of the container must not be more than 25 millilitres. When the concentration is more than 25%, and the nominal capacity of the container is less than or equal to 15 millilitres, a restricted flow insert must be fitted on the container and requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect); and - (NTAKEN) 'Not to be taken'. When the concentration is more than 25%, and the nominal capacity of the container is more than 15 millilitres but not more than 25 millilitres, a child resistant closure and restricted flow insert must be fitted on the container and requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect); and - (NTAKEN) 'Not to be taken'. 3000 LESPEDEZA CAPITATA A, H 3001 LETTUCE E 3002 LEUCINE A, E 3003 LEUZEA UNIFLORA A, H 3004 LEVISTICUM OFFICINALE A, H 3005 LEVOCARNITINE A 3006 LEVOCARNITINE FUMARATE A 3007 LEVOCARNITINE HYDROCHLORIDE A 3008 LEVOCARNITINE MAGNESIUM CITRATE A 3009 LEVOCARNITINE TARTRATE A 3010 LEVOMEFOLATE CALCIUM A Available for medicines intended for internal use only. Levomefolic acid is a mandatory component of levomefolate calcium. The maximum recommended daily dose must not provide more than 500 micrograms of levomefolic acid from levomefolate calcium. When the medicine contains a combination of folic acid, folinic acid or levomefolic acid, the medicine must not provide more than a combined total of 500 micrograms of folic acid, folinic acid and levomefolic acid per maximum recommended daily dose. 3011 LEVOMEFOLATE GLUCOSAMINE A Available for medicines intended for internal use only. Levomefolic acid is a mandatory component of levomefolate glucosamine. The maximum recommended daily dose must not provide more than 500 micrograms of levomefolic acid from levomefolate glucosamine. When the medicine contains a combination of folic acid, folinic acid or levomefolic acid, the medicine must not provide more than a combined total of 500 micrograms of folic acid, folinic acid and levomefolic acid per maximum recommended daily dose. 3012 LEVOTHYROXINE SODIUM H Only for use as an active homoeopathic ingredient. 3013 LEVULINIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3014 LIGHT KAOLIN E 3015 LIGHT LIQUID PARAFFIN A, E When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 3016 LIGHT MAGNESIUM OXIDE A, E, H Magnesium is a mandatory component of light magnesium oxide. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 3017 LIGUSTICUM SINENSE A, H 3018 LIGUSTICUM STRIATUM A, E, H 3019 LIGUSTRUM LUCIDUM A, H 3020 LILIUM BROWNII A, H 3021 LILIUM CANDIDUM A, E, H 3022 LILIUM LANCIFOLIUM A, H 3023 LILIUM LONGIFLORUM A, H 3024 LIME FRUIT E 3025 LIME OIL E Lime oil must only be included in medicines when in combination with other permitted ingredients as a flavour or a fragrance proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing lime oil must not be more than 5% of the total medicine. The total concentration of fragrance proprietary excipient formulations containing lime oil must not be more than 1% of the total medicine. When for other than internal use: (a) the concentration of lime oil in the medicine must not be more than 0.5%; or (b) the following warning statement (or words to the same effect) is required on the medicine label: - (SENS) 'Application to the skin may increase sensitivity to sunlight'. 3026 LIME OIL COLDPRESSED A, E, H The warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) contains 0.5% or less of lime oil coldpressed; or c) for use in soaps or bath or shower gels that are washed off the skin. 3027 LIME OIL DISTILLED A, E, H The warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) contains 0.5% or less of lime oil distilled; or c) for use in soaps or bath or shower gels that are washed off the skin. 3028 LIME OIL TERPENELESS E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3029 LIME OIL TERPENES AND TERPENOIDS E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3030 LIME TREE FLOWER DRY A, H 3031 LIME TREE FLOWER POWDER A, H 3032 LIME, ESSENCE E 3033 LIMES TERPENES E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3034 LIMONENE E When for oral use, the quantity must be no more than 10 mg per maximum recommended daily dose. 3035 LINALOOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3036 LINALOOL OXIDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3037 LINALYL ACETAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3038 LINALYL ACETATE E Permitted for use only: (a) in topical medicines for dermal application; and (b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. 3039 LINALYL BENZOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3040 LINALYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3041 LINALYL CINNAMATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3042 LINALYL FORMATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3043 LINALYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3044 LINALYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3045 LINDERA STRYCHNIFOLIA A, H 3046 LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 3047 LINOLEIC ACID E 3048 LINOLENIC ACID E 3049 LINSEED DRY A, E, H 3050 LINSEED OIL A, E, H 3051 LINSEED OIL FATTY ACIDS E Linseed oil fatty acids must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing linseed oil fatty acids must not be more than 5% of the total medicine. 3052 LINSEED POWDER A, E, H 3053 LINUM USITATISSIMUM A, E, H 3054 LIPASE A Permitted for use only when derived from Rhizopus oryzae and in medicines containing 20,000 lipase units (equivalent to 20,000 BP units) or less of lipase activity per dosage unit. Lipase must comply with the relevant compositional guideline. 3055 LIPPIA DULCIS A, H 3056 LIQUID GLUCOSE E 3057 LIQUID PARAFFIN A, E When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 3058 LIQUIDAMBAR FORMOSANA A, H 3059 LIQUIDAMBAR ORIENTALIS A, H 3060 LIQUIDAMBAR STYRACIFLUA A, E, H 3061 LIQUIDAMBAR STYRACIFLUA RESIN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3062 LIQUIDAMBAR TAIWANIANA A, H 3063 LIQUORICE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3064 LIQUORICE DRY A, E, H 3065 LIQUORICE LIQUID EXTRACT A, E, H 3066 LIQUORICE POWDER A, E, H 3067 LITCHI CHINENSIS A, E, H When used as an excipient, Litchi chinensis must only be included in medicines when the plant part is fruit, in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing Litchi chinensis must not be more than 5% of the total medicine. 3068 LITHIUM CARBONATE H Only for use as an active homoeopathic ingredient. 3069 LITHOSPERMUM OFFICINALE A, H The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Lithospermum officinale. 3070 LITSEA CUBEBA A, E, H 3071 LITSEA CUBEBA OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3072 LOBARIA PULMONARIA A, H 3073 LOBELIA DRY A, H The concentration in the medicine must be no more than 0.001% or 10mg/kg or 10ml/L or 10 ppm unless the medicine is administered by inhalation. 3074 LOBELIA INFLATA A, H The concentration in the medicine must be no more than 0.001% or 10mg/kg or 10ml/L or 10 ppm unless the medicine is administered by inhalation. 3075 LOBELIA POWDER A, H The concentration in the medicine must be no more than 0.001% or 10mg/kg or 10ml/L or 10 ppm unless the medicine is administered by inhalation. 3076 LOLIUM PERENNE A, H 3077 LOLIUM TEMULENTUM A, H 3078 LONGIFOLENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total longifolene concentration in a medicine must be no more than 1%. 3079 LONICERA CAPRIFOLIUM A, E, H 3080 LONICERA JAPONICA A, E, H 3081 LONICERA PERICLYMENUM A, H 3082 LOPHATHERUM GRACILE A, H 3083 LOQUAT E 3084 LORANTHUS PARASITICUS A, H 3085 LOROPETALUM CHINENSE A, H 3086 LOTUS CORNICULATUS A, H 3087 LOVAGE OIL A, E, H 3088 LOVAGE ROOT DRY A, H 3089 LOVAGE ROOT POWDER A, H 3090 LUDWIGIA PROSTRATA A, H 3091 LUFFA CYLINDRICA A, H 3092 LUFFA PURGANS A, H 3093 LUTEIN A, E, H When used as an excipient, permitted for use only as a colour in medicines limited to topical and oral routes of administration. 3094 LYCHEE E 3095 LYCIUM BARBARUM A, H 3096 LYCIUM CHINENSE A, E, H 3097 LYCOPENE A, E 3098 LYCOPERSICON ESCULENTUM A, E, H Steroidal alkaloids calculated as solanine is a mandatory component of Lycopersicon esculentum. The maximum daily dose must not provide more than 10 mg of steroidal alkaloids calculated as solanine. 3099 LYCOPODIUM ANNOTINUM A, H 3100 LYCOPODIUM CLAVATUM A, H 3101 LYCOPODIUM COMPLANATUM A, H 3102 LYCOPUS EUROPAEUS A, H 3103 LYCOPUS LUCIDUS A, H 3104 LYCOPUS VIRGINICUS A, H Pulegone is a mandatory component of Lycopus virginicus. The concentration of pulegone in the medicine must be no more than 4%. 3105 LYGODIUM JAPONICUM A, H 3106 LYSIMACHIA CHRISTINAE A, H 3107 LYSIMACHIA VULGARIS A, H 3108 LYSINE A, E 3109 LYSINE HYDROCHLORIDE A, E 3110 LYTHRUM HYSSOPIFOLIA A, H 3111 LYTHRUM SALICARIA A, H 3112 LYTHRUM VERTICILLATUM A, H 3113 MACADAMIA INTEGRIFOLIA A, E 3114 MACADAMIA NUT OIL E 3115 MACADAMIA TERNIFOLIA A, E, H 3116 MACE E Safrole is a mandatory component of Mace. When used internally, the concentration of safrole in the medicine must be no more than 0.1%. When used topically, the concentration of safrole in the medicine must be no more than 1.0%. 3117 MACE OIL A, H Safrole is a mandatory component of Mace oil. When used internally, the concentration of safrole in the medicine must be no more than 0.1%. When used topically, the concentration of safrole in the medicine must be no more than 1.0%. When the concentration of mace oil in the preparation is more than 50% and the nominal capacity of the container is 25 mL or less, a restricted flow insert must be fitted on the container. 3118 MACROCYSTIS PYRIFERA A, E, H Iodine is a mandatory component of Macrocystis pyrifera. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 3119 MACROGOL 1000 E 3120 MACROGOL 1450 E Only for use in topical medicines for dermal application. 3121 MACROGOL 1500 E 3122 MACROGOL 1500 CASTOR OIL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. 3123 MACROGOL 200 E Only for use in topical medicines for dermal application. 3124 MACROGOL 20000 E 3125 MACROGOL 300 E 3126 MACROGOL 3000 E 3127 MACROGOL 3350 A, E When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing form time to time. 3128 MACROGOL 40 E Only for use in topical medicines for dermal application. 3129 MACROGOL 400 E 3130 MACROGOL 4000 E 3131 MACROGOL 45000 E Only for use in topical medicines for dermal application. 3132 MACROGOL 600 E 3133 MACROGOL 6000 E 3134 MACROGOL 600000 E 3135 MACROGOL 800 E 3136 MACROGOL 8000 E 3137 MACROGOL 900 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.95%. 3138 MACROGOL POLY(VINYL ALCOHOL) GRAFTED POLYMER E Only for use in oral medicines. The concentration in the medicine must be no more than 5%. 3139 MACROPIPER EXCELSUM VAR EXCELSUM A, H 3140 MAGNESIUM AMINO ACID CHELATE A, E, H Only for use in oral medicines. The concentration of magnesium must be no more than 25% of the magnesium amino acid chelate. 3141 MAGNESIUM ASCORBATE A, E, H 3142 MAGNESIUM ASCORBATE MONOHYDRATE A, E, H 3143 MAGNESIUM ASCORBYL PHOSPHATE E Only for use in topical medicines for dermal application. 3144 MAGNESIUM ASPARTATE A, E, H 3145 MAGNESIUM ASPARTATE DIHYDRATE A, E, H 3146 MAGNESIUM ASPARTATE TETRAHYDRATE A, E, H 3147 MAGNESIUM CARBONATE HYDRATE A, E, H 3148 MAGNESIUM CHLORIDE 4.5-HYDRATE A Magnesium is a mandatory component of magnesium chloride 4.5-hydrate. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 3149 MAGNESIUM CHLORIDE HEXAHYDRATE A, E, H Magnesium is a mandatory component of magnesium chloride hexahydrate. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 3150 MAGNESIUM CITRATE A, E, H 3151 MAGNESIUM CITRATE NONAHYDRATE A, E, H 3152 MAGNESIUM CITRATE TETRADECAHYDRATE A, E, H 3153 MAGNESIUM DIGLUTAMATE A, E, H 3154 MAGNESIUM GLUCONATE A, E, H 3155 MAGNESIUM GLYCEROPHOSPHATE A, E, H 3156 MAGNESIUM GLYCINATE A Only for use in oral medicines. 3157 MAGNESIUM GLYCINATE DIHYDRATE A Only for use in oral medicines. Magnesium is a mandatory component of Magnesium glycinate dihydrate. The percentage of Magnesium from Magnesium glycinate dihydrate should be calculated based on the molecular weight of Magnesium glycinate dihydrate. 3158 MAGNESIUM HYDROGEN PHOSPHATE H Magnesium is a mandatory component of magnesium hydrogen phosphate. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 3159 MAGNESIUM HYDROXIDE A, E When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. Magnesium is a mandatory component of magnesium hydroxide. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 3160 MAGNESIUM LYSINATE A Only for use in oral medicines. 3161 MAGNESIUM METHIONINATE A Only for use in oral medicines. 3162 MAGNESIUM NITRATE E Only for use in topical medicines for dermal application. 3163 MAGNESIUM OROTATE A, E, H 3164 MAGNESIUM OROTATE DIHYDRATE A, E, H 3165 MAGNESIUM OXIDE A, E, H Magnesium is a mandatory component of magnesium oxide. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 3166 MAGNESIUM PHOSPHATE PENTAHYDRATE A, E, H Magnesium is a mandatory component of magnesium phosphate pentahydrate. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 3167 MAGNESIUM PHOSPHATE TRIBASIC A, E, H Magnesium is a mandatory component of magnesium phosphate tribasic. The percentage of magnesium from magnesium phosphate tribasic should be calculated based on the molecular weight of magnesium phosphate tribasic. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 3168 MAGNESIUM PYRUVATE A Only for use in oral medicines. The maximum recommended daily dose must be no more than 7 grams. 3169 MAGNESIUM STEARATE E 3170 MAGNESIUM SULFATE DIHYDRATE A, E, H When used internally, the maximum recommended daily dose must not be more than 1.5g. Magnesium is a mandatory component of magnesium sulfate dihydrate. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 3171 MAGNESIUM SULFATE HEPTAHYDRATE A, E, H When used internally, the maximum recommended daily dose must not be more than 1.5 g. Magnesium is a mandatory component of magnesium sulfate heptahydrate. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 3172 MAGNESIUM SULFATE MONOHYDRATE A, E, H When used internally, the maximum recommended daily dose must not be more than 1.5 g. Magnesium is a mandatory component of magnesium sulfate monohydrate. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 3173 MAGNESIUM SULFATE TRIHYDRATE A, E, H When used internally, the maximum recommended daily dose must not be more than 1.5 g. Magnesium is a mandatory component of magnesium sulfate trihydrate. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 3174 MAGNESIUM TRISILICATE E Magnesium is a mandatory component of magnesium trisilicate. When used in a medicine: (a) with an oral route of administration; (b) not indicated for laxative (or related) use; and (c) where the maximum recommended daily dose for: (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect). When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age. 3175 MAGNOLIA GLAUCA A, H 3176 MAGNOLIA LILIFLORA A, H 3177 MAGNOLIA OBOVATA A, H 3178 MAGNOLIA OFFICINALIS A, E, H 3179 MAGNOLIA SALICIFOLIA A, H 3180 MAIZE OIL A, E, H 3181 MAIZE STARCH A, E, H 3182 MALACHITE GREEN E Permitted for use only as a colour for topical use. 3183 MALIC ACID E Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished medicine is safe for its intended purpose. 3184 MALPIGHIA GLABRA A, E, H 3185 MALT EXTRACT E 3186 MALTITOL E 3187 MALTITOL SOLUTION E 3188 MALTODEXTRIN E Gluten is a mandatory component of Maltodextrin where the ingredient is derived from gluten containing grains such as wheat, barley, rye and oats. 3189 MALTOL E 3190 MALTONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3191 MALTOSE E 3192 MALUS DOMESTICA A, E, H The concentration of amygdalin in the medicine must be no more than 0%. 3193 MALUS SYLVESTRIS A, H 3194 MALVA MOSCHATA A, H 3195 MALVA SYLVESTRIS A, E, H 3196 MALVA VERTICILLATA A, H 3197 MANDARIN E 3198 MANDARIN OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3199 MANDARIN OIL COLDPRESSED A, E, H When used internally, oxedrine is a mandatory component of mandarin oil coldpressed. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. 3200 MANDARIN OIL TERPENES E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3201 MANDARIN RESIDUE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3202 MANDRAGORA OFFICINARUM A, H Atropine, hyoscine and hyoscyamine are mandatory components of Mandragora officinarum. The concentration in the medicine must be no more than 10 mg/kg or 10 mL/L or 0.001%. The concentration of atropine in the medicine must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%. The concentration of hyoscine in the medicine must be no more than 300 micrograms/kg or 300 micrograms/L or 0.00003%. The concentration of hyoscyamine in the medicine must be no more than 300 micrograms/kg or 300 micrograms/L or 0.00003%. 3203 MANGANESE H Only for use as an active homoeopathic ingredient. 3204 MANGANESE (II) DIASPARTATE A, H Only for use in oral medicines. 3205 MANGANESE (II) GLYCINATE A, H Only for use in oral medicines. 3206 MANGANESE ACETATE TETRAHYDRATE H Only for use as an active homoeopathic ingredient. 3207 MANGANESE AMINO ACID CHELATE A, E, H Only for use in oral medicines. The concentration of Manganese must be no more than 25% of the manganese amino acid chelate. 3208 MANGANESE CHLORIDE TETRAHYDRATE A, E, H 3209 MANGANESE DIASPARTATE A, E, H Only for use in oral medicines. 3210 MANGANESE GLUCONATE A, E, H 3211 MANGANESE GLYCEROPHOSPHATE A, E, H 3212 MANGANESE OXIDE A, E, H 3213 MANGANESE SULFATE MONOHYDRATE A, E, H 3214 MANGANESE SULFATE TETRAHYDRATE A, E, H 3215 MANGIFERA INDICA A, E, H 3216 MANGO E, H 3217 MANIHOT ESCULENTA A, H 3218 MANNITOL E 3219 MARANTA ARUNDINACEA A, H 3220 MARINE SPONGE H Only for use as an active homoeopathic ingredient. 3221 MARJORAM OIL SPANISH A, E, H When the concentration in the preparation is more than 50%, the nominal capacity of the container must be no more than 50 mL, the medicine must have a restricted flow insert fitted to the container and requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). 3222 MARJORAM OIL SWEET A, E, H When the concentration in the preparation is more than 50%, the nominal capacity of the container must be no more than 50 mL, the medicine must have a restricted flow insert fitted to the container and requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). 3223 MARRUBIUM VULGARE A, E, H 3224 MARSDENIA CUNDURANGO A, H 3225 MARSHMALLOW ROOT DRY A, H 3226 MARSHMALLOW ROOT POWDER A, H 3227 MASSOIA LACTONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3228 MASTIC A, H 3229 MATE ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3230 MATRICARIA CHAMOMILLA A, E, H 3231 MATRICARIA FLOWER DRY A, E, H 3232 MEADOWSWEET HERB DRY A, H Methyl salicylate is a mandatory component of meadowsweet herb dry. Not to be included in medicines for use in the eye or on damaged skin. When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is spray, the medicine does not require child resistant packaging if: - the delivery device is engaged into the container in such a way that prevents it from being readily removed; - direct suction through the delivery device results in delivery of no more than one dosage unit; and - actuation of the spray device is ergonomically difficult for young children to accomplish. The following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect). When for use in topical medicines for dermal application i) the concentration of methyl salicylate in the medicine must not be more than 25% ii) the following warning statements are required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less'; - (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect); - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect); iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label: - (IRRIT) 'If irritation develops, discontinue use'. 3233 MECOBALAMIN A Only for use in oral medicines. 3234 MEDICAGO SATIVA A, E, H The level of l-canavanine must be no more than that of the dried leaf. When fresh leaf extract is used and the extraction ratio is between 34:1 and 46:1, the quantity of l-canavanine in the extract must not be more than that in the fresh leaf. 3235 MEDIUM CHAIN TRIGLYCERIDES E 3236 MELALEUCA ALTERNIFOLIA A, E, H Cineole is a mandatory component of Melaleuca alternifolia. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 3237 MELALEUCA CAJUPUTI A, E, H Cineole is a mandatory component of Melaleuca cajuputi. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 3238 MELALEUCA CITRINA A, H 3239 MELALEUCA DISSITIFLORA A, H Cineole is a mandatory component of Melaleuca dissitiflora. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 3240 MELALEUCA ERICIFOLIA A, E, H Cineole is a mandatory component of Melaleuca ericifolia. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 3241 MELALEUCA LINARIIFOLIA A, H Cineole is a mandatory component of Melaleuca linariifolia. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 3242 MELALEUCA OIL A, E, H Cineole and cajuput oil are a mandatory components of Melaleuca Oil. When the plant preparation is oil and the concentration in the medicine is more than 25%, the nominal capacity of the container must be no more than 25 mL and the medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect) - (NTAKEN) 'Not to be taken'. When the nominal capacity of the container is 15 mL or less, then a restricted flow insert must be fitted on the container. Where the nominal capacity of the container is more than 15 mL but less than or equal to 25 mL, then a child resistant closure and restricted flow insert must be fitted on the container. 3243 MELALEUCA QUINQUENERVIA A, E, H Cineole is a mandatory component of Melaleuca quinquenervia. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. 3244 MELICOPE PTELEIFOLIA A, H 3245 MELILOTUS OFFICINALIS A, E, H Coumarin is a mandatory component of Melilotus officinalis. The concentration of coumarin in the medicine must be no more than 0.001%. 3246 MELISSA OFFICINALIS A, E, H 3247 MELON E 3248 MENADIONE SODIUM BISULFITE E 3249 MENAQUINONE 7 A For oral use only. The medicine must not provide more than 180 micrograms per maximum daily dose in adults, 90 micrograms per maximum daily dose in children between 10-18 years, and 45 micrograms per maximum daily dose in children less than 10 years of age. 3250 MENISPERMUM CANADENSE A, H 3251 MENTHA AQUATICA A, H Menthol is a mandatory component of Mentha aquatica. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3252 MENTHA ARVENSIS A, E, H Menthol is a mandatory component of Mentha arvensis. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3253 MENTHA ARVENSIS LEAF OIL E Permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation or fragrance proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. The total fragrance proprietary excipient formulation in a medicine must be no more 1%. Menthol is a mandatory component of Mentha arvensis leaf oil. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3254 MENTHA ARVENSIS OIL E Permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must not be more than 5%. Menthol is a mandatory component of Mentha arvensis oil. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statements is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3255 MENTHA HAPLOCALYX A, E, H Menthol is a mandatory component of Mentha haplocalyx. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3256 MENTHA PULEGIUM A, H D-pulegone, menthol and volatile oil components (of Mentha pulegium) are mandatory components of Mentha pulegium. When the nominal capacity of the container is more than 15 millilitres, the concentration of d-pulegone in the medicine must be no more than 4%. When the concentration of d-pulegone in the preparation is more than 4% and the nominal capacity of the container is 15 millilitres or less, the medicine must have a child resistant closure and restricted flow insert fitted on the container. The medicine requires the following warning statements on the medicine label: - (NTAKEN) 'Not to be taken'; - (CHILD) 'Keep out of reach of children' (or words to that effect). When the medicine is for topical use for dermal application: a) the maximum recommended daily dose must not contain more than 150 mg of Mentha pulegium oil or distillate; b) the medicine must not be intended for use in the eye or on damaged skin; c) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; d) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). e) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. f) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use: a) the maximum recommended daily dose must not contain more than 50 mg of Mentha pulegium oil or distillate; b) the maximum recommended daily dose must not contain more than 1 gram of menthol. 3257 MENTHA SPICATA A, E, H Menthol is a mandatory component of Mentha spicata. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3258 MENTHA X CARDIACA A, E, H Menthol is a mandatory component of Mentha x cardiaca. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3259 MENTHA X PIPERITA A, E, H Menthol is a mandatory component of Mentha x piperita. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3260 MENTHADIENYL ACETATE E Menthadienyl acetate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of the flavour proprietary excipient formulation containing menthadienyl acetate must not be more than 5% of the total medicine. 3261 MENTHANYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3262 MENTHOFURAN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3263 MENTHOL A, E When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3264 MENTHONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3265 MENTHONE GLYCERINE ACETAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3266 MENTHONE THIOL FRACTION E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3267 MENTHOXYPROPANEDIOL E For oral use only. The concentration in the medicine must be no more than 0.04%. 3268 MENTHYL 2-HYDROXYETHYL CARBONATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3269 MENTHYL 2-HYDROXYPROPYL CARBONATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3270 MENTHYL ANTHRANILATE A Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 5%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 3271 MENTHYL ISOVALERATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3272 MENTHYL LACTATE E 3273 MENYANTHES TRIFOLIATA A, H 3274 MERCURIC CHLORIDE H Only for use as an active homoeopathic ingredient. Mercury is a mandatory component of mercuric chloride. The total concentration of mercury in the medicine must not be more than 1 mg/kg or 1 mg/L or 0.0001%. 3275 MERCURY H Only for use as an active homoeopathic ingredient. The total concentration of mercury in the medicine must not be more than 1 mg/kg or 1 mg/L or 0.0001%. 3276 METACRESOL E Only for use in topical medicines for dermal application. 3277 METHACRYLIC ACID COPOLYMER E Only for use in oral medicines. 3278 METHANOL E The residual solvent limit is 30 mg per recommended daily dose. The concentration in the medicine must be no more than 0.3%. 3279 METHICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 3280 METHIONINE A, E 3281 METHYL 2,6,6-TRIMETHYLCYCLOHEX-2-ENE-1-CARBOXYLATE E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%. 3282 METHYL 2-METHYLBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3283 METHYL 2-OCTYNOATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3284 METHYL 3,6-DIMETHYLRESORCYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3285 METHYL ACETATE E The residual solvent limit is 50 mg per recommended daily dose. The concentration in the medicine must be no more than 0.5%. 3286 METHYL ACETOPHENONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3287 METHYL ACETYL RICINOLEATE E Only for use in topical medicines for dermal application. 3288 METHYL ACRYLATE, METHYL METHACRYLATE AND METHACRYLIC ACID COPOLYMER DISPERSION (30 PER CENT) E Methyl methacrylate is a mandatory component of methyl acrylate, methyl methacrylate and methacrylic acid copolymer dispersion (30 per cent). The total concentration of methyl methacrylate as residual monomer in the medicine must not be more than 1%. The route of administration for medicines that contain methyl acrylate, methyl methacrylate and methacrylic acid copolymer dispersion (30 per cent) must be limited to oral use. Methyl acrylate, methyl methacrylate and methacrylic acid copolymer dispersion (30 per cent) is not permitted for use in children under the age of 4 years. The maximum recommended daily dose of the medicine must not provide more than: (a) 667 milligrams of methyl acrylate, methyl methacrylate and methacrylic acid copolymer dispersion (30 per cent) to individuals aged 4 to 17 years (inclusive); and (b) 2.33 grams of methyl acrylate, methyl methacrylate and methacrylic acid copolymer dispersion (30 per cent) to individuals aged 18 years and above. 3289 METHYL ANISATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3290 METHYL ANTHRANILATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3291 METHYL BENZOATE E Only for use in topical medicines for dermal application. 3292 METHYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3293 METHYL CAPROATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3294 METHYL CAPRYLATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3295 METHYL CARBITOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3296 METHYL CEDRYL KETONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3297 METHYL CHAVICOL E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The ingredient is not to be included in medicines intended for oral use. The quantity of methyl chavicol in a medicine must be no more than 0.01%. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 3298 METHYL CINNAMATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3299 METHYL CIS-5-OCTENOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3300 METHYL CYCLOPENTENOLONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3301 METHYL CYCLOPENTYLIDENEACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3302 METHYL DI-TERT-BUTYL-4-HYDROXYHYDROCINNAMATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3303 METHYL DIHYDROABIETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3304 METHYL DIISOPROPYL PROPIONAMIDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3305 METHYL ETHER E Only for use in topical medicines for dermal application. 3306 METHYL ETHYL KETONE E The residual solvent limit is 50 mg per maximum recommended daily dose. The concentration in the medicine must be no more than 0.5%. 3307 METHYL EUGENOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3308 METHYL FUROATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3309 METHYL GLUCETH-10 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. Residue levels of ethylene oxide are to be kept below the level of detection. 3310 METHYL GLUCETH-20 E Only for use in topical medicines for dermal application. 3311 METHYL GLUCETH-20 BENZOATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3312 METHYL GLUCETH-20 SESQUIHYDRATE E Only for use in topical medicines for dermal application. 3313 METHYL GLUCOSE DIOLEATE E Only for use in topical medicines for dermal application. 3314 METHYL GLUCOSE SESQUIOLEATE E Only for use in topical medicines for dermal application. 3315 METHYL GLUCOSE SESQUISTEARATE E Only for use in topical medicines for dermal application. 3316 METHYL HEPTANOATE E Permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must not be more than 5%. 3317 METHYL HEPTENONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3318 METHYL HEPTYL KETONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3319 METHYL HEXYL CARBINOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3320 METHYL HEXYL KETONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3321 METHYL HYDROGENATED ROSINATE E Only for use in topical medicines for dermal application. 3322 METHYL HYDROJASMONATE E The route(s) of administration for medicines that contain methyl hydrojasmonate must be limited to: (a) topical for dermal use; and (b) oral. When used in oral medicines: (a) methyl hydrojasmonate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation; and (b) the total concentration of flavour proprietary excipient formulations containing methyl hydrojasmonate must not be more than 5% of the total medicine. 3323 METHYL HYDROXYBENZOATE E 3324 METHYL IONONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3325 METHYL ISOBUTYL KETONE E The residual solvent limit is 50 mg per maximum daily dose. The concentration in the medicine must be no more than 0.5%. 3326 METHYL ISOEUGENOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3327 METHYL ISOVALERATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3328 METHYL JASMONATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3329 METHYL LAURATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. 3330 METHYL LINOLEATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3331 METHYL LINOLENATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3332 METHYL MAGNESIUM CHLORIDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3333 METHYL METHACRYLATE CROSSPOLYMER E Methyl methacrylate is a mandatory component of methyl methacrylate crosspolymer. Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. When the concentration of methyl methacrylate crosspolymer is greater than 1%, the medicine must not be intended for use on damaged skin. The total concentration of methyl methacrylate crosspolymer in the medicine must not be more than 4.85%. The total concentration of methyl methacrylate as residual monomer in the medicine must not be more than 1%. 3334 METHYL METHOXY PYRAZINE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3335 METHYL MYRISTATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3336 METHYL NAPHTHYL KETONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3337 METHYL NONYL KETONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3338 METHYL NONYLENATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3339 METHYL OCTIN CARBONATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3340 METHYL PALMITATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3341 METHYL PHENYL CARBINOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3342 METHYL PHENYL CARBINYL-ISO-BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3343 METHYL PHENYL GLYCIDATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3344 METHYL PHENYLACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3345 METHYL PHENYLCARBINYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3346 METHYL ROSINATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3347 METHYL SALICYLATE A, E Not to be included in medicines for use in the eye or on damaged skin. When used internally, the concentration in the medicine must not be more than 0.001%. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is spray, the medicine does not require child resistant packaging if: - the delivery device is engaged into the container in such a way that prevents it from being readily removed; - direct suction through the delivery device results in delivery of no more than one dosage unit; and - actuation of the spray device is ergonomically difficult for young children to accomplish. The following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect). When for use in topical medicines for dermal application: i) the concentration of methyl salicylate in the medicine must not be more than 25%; ii) the following warning statements are required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less'; - (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect); - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect); iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label: - (IRRIT) 'If irritation develops, discontinue use'. 3348 METHYL STEARATE E 3349 METHYL THIOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3350 METHYL TRIMETICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 3351 METHYL-3-METHYLTHIOPROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3352 METHYL-BETA-METHYL THIOLPROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3353 METHYL-PARA-TERT-BUTYL PHENYLACETATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3354 METHYLBENZYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3355 METHYLCELLULOSE A, E 3356 METHYLCHLOROISOTHIAZOLINONE E Only for use in topical medicines for dermal application that are rinsed off the skin. The total concentration of methylchloroisothiazolinone and methylisothiazolinone in the medicine must be no more than 0.0015%. 3357 METHYLCYCLOHEXADIENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3358 METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 3359 METHYLISOTHIAZOLINONE E Only for use in topical medicines for dermal application that are rinsed off the skin. The total concentration of methylchloroisothiazolinone and methylisothiazolinone in the medicine must be no more than 0.0015%. 3360 METHYLMERCAPTAN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3361 METHYLPROPANEDIOL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. 3362 METHYLSILANOL/SILICATE CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.1%. 3363 METHYLSTYRENE/VINYLTOLUENE COPOLYMER E Only for use in topical medicines for dermal application. 3364 MICA E Only for use when the route of administration is oral, dental or topical. The concentration in oral medicines must be no more than 2.5%. The concentration in dental toothpastes must be no more than 0.5%. 3365 MICROCALICIUM ARENARIUM A, H 3366 MICROCOCCUS LUTEUS LYSATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.005%. 3367 MICROCOS PANICULATA A, H 3368 MICROCRYSTALLINE CELLULOSE E 3369 MICROCRYSTALLINE WAX E Only for use as an excipient in medicines for topical, oral or oral application routes of administration. When microcrystalline wax is used as an excipient ingredient, the route of administration 'oral' is only permitted when the dosage form is 'chewing gum'. 3370 MILK FAT E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3371 MILK THISTLE FRUIT DRY A, H 3372 MILK THISTLE FRUIT POWDER A, H 3373 MILLET E 3374 MILLETTIA DIELSIANA A, H 3375 MIMOSA ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3376 MIMULUS GUTTATUS A, H 3377 MINT OIL DEMENTHOLISED A, E, H Menthol is a mandatory component of mint oil dementholised. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3378 MINTLACTONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3379 MITCHELLA REPENS A, H 3380 MIXED (HIGH-ALPHA TYPE) TOCOPHEROLS CONCENTRATE A, E 3381 MIXED (LOW-ALPHA TYPE) TOCOPHEROLS CONCENTRATE A, E 3382 MIXED TERPENES E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3383 MODIFIED FOOD STARCH E 3384 MOLASSES E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3385 MOLYBDENUM H Only for use as an active homoeopathic ingredient. When Molybdenum is sourced from Molybdenum trioxide then the maximum daily dose must be no more than 125 micrograms. When Molybdenum is sourced from yeast - high molybdenum then the maximum recommended daily dose must be no more than 62.5 micrograms. 3386 MOLYBDENUM TRIOXIDE A Molybdenum is a mandatory component of Molybdenum trioxide. The maximum daily dose of molybdenum from Molybdenum trioxide must be no more than 125 micrograms. The percentage of molybdenum from molybdenum trioxide should be calculated based on the molecular weight of molybdenum trioxide. 3387 MOMORDICA BALSAMINA A, H 3388 MOMORDICA CHARANTIA A, H 3389 MOMORDICA COCHINCHINENSIS A, H 3390 MONARDA DIDYMA A, H 3391 MONO- AND DI- GLYCERIDES E 3392 MONOBASIC AMMONIUM PHOSPHATE E Only for use in topical medicines for dermal application. 3393 MONOBASIC CALCIUM PHOSPHATE A, E, H 3394 MONOBASIC POTASSIUM PHOSPHATE A, E, H When used in a solid medicine containing this ingredient, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid medicine containing this ingredient, the pH of the medicine must be no more than 11.5. 3395 MONOBASIC SODIUM PHOSPHATE A, E, H When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 3396 MONOBASIC SODIUM PHOSPHATE DIHYDRATE E When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 3397 MONOETHANOLAMINE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%. 3398 MONOMENTHYL GLUTARATE E Monomenthyl glutarate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing monomenthyl glutarate must not be more than 5% of the total medicine. The maximum recommended daily dose of the medicine must not provide more than 1.8mg of monomenthyl glutarate. 3399 MONOMENTHYL SUCCINATE E Monomenthyl succinate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of the flavour proprietary excipient formulation containing monomenthyl succinate must not be more than 5% of the total medicine. 3400 MONOPHOSPHOTHIAMINE A 3401 MONOPHOSPHOTHIAMINE DIHYDRATE A 3402 MONOPOTASSIUM GLUTAMATE A, E 3403 MONOSODIUM DIHYDROGEN CITRATE E 3404 MONOSODIUM GLUTAMATE MONOHYDRATE A, E 3405 MONSTERA DELICIOSA A, H 3406 MONTAN WAX E 3407 MORDANT RED 11 E Permitted for use only as a colour for topical use. The concentration in the medicine must be no more than 0.05%.. 3408 MORINDA CITRIFOLIA A, H Only for use when the plant part is fruit and the plant preparation is fruit juice or fruit powder. Fruit powder must be produced by freeze drying the whole fruit (excluding the seeds). 3409 MORINDA OFFICINALIS A, H 3410 MORINGA OLEIFERA A, H 3411 MORUS ALBA A, H 3412 MORUS BOMBYCIS A, H 3413 MORUS NIGRA A, E, H 3414 MOSKENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3415 MOTHERWORT HERB DRY A, H 3416 MOTHERWORT HERB POWDER A, H 3417 MUCUNA PRURIENS A Levodopa is a mandatory component of Mucuna pruriens. The concentration of levodopa in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 3418 MULBERRY E 3419 MUNG BEAN E 3420 MURRAYA KOENIGII A, H 3421 MURRAYA PANICULATA A, H 3422 MUSA X PARADISIACA A, H 3423 MUSK KETONE E Only for use in topical medicines for dermal application. 3424 MUSK TIBETENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3425 MUSK XYLOL E Only for use in topical medicines for dermal application. 3426 MUSKS H Only for use as an active homoeopathic ingredient. 3427 MUSTARD E Allyl isothiocyanate is a mandatory component of mustard when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 3428 MUSTARD OIL E Allyl isothiocyanate is a mandatory component of mustard oil when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 3429 MUSTARD SEED OIL E Allyl isothiocyanate is a mandatory component of mustard seed oil when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 3430 MYOSOTIS ARVENSIS A, H 3431 MYRCENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3432 MYRCENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3433 MYRICA CERIFERA A, E, H 3434 MYRISTIC ACID E 3435 MYRISTIC ALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3436 MYRISTICA FRAGRANS A, E, H Safrole is a mandatory component of Myristica fragrans. When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%. When the plant preparation is oil or distillate and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect). 3437 MYRISTYL ALCOHOL E Only for use in topical medicines for dermal application. 3438 MYRISTYL LACTATE E Only for use in topical medicines for dermal application. 3439 MYRISTYL MYRISTATE E Only for use in topical medicines for dermal application. 3440 MYROXYLON BALSAMUM A, E, H 3441 MYROXYLON BALSAMUM VAR. PEREIRAE A, H 3442 MYRRH A, H 3443 MYRRH OIL A, E, H 3444 MYRRH RESIN E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3445 MYRRHIS ODORATA A, H 3446 MYRSINE AFRICANA A, H 3447 MYRTENAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3448 MYRTENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3449 MYRTLE OIL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used as a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3450 MYRTUS COMMUNIS A, E, H 3451 N,N'-BIS(SALICYLIDENE)PROPYLENEDIAMINE E N,N'-Bis(salicylidene)propylenediamine must only be included in medicines when in combination with other permitted ingredients as a proprietary excipient formulation in medicines with a dermal route of administration for topical application. 3452 N-(2-(PYRIDIN-2-YL)ETHYL)-P-MENTHANE-3-CARBOXAMIDE E N-(2-(pyridin-2-yl)ethyl)-p-menthane-3-carboxamide must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing N-(2-(pyridin-2-yl)ethyl)-p-menthane-3-carboxamide must not be more than 5% of the total medicine. The maximum recommended daily dose of the medicine must not provide more than 90 micrograms of N-(2-(pyridin-2-yl)ethyl)-p-menthane-3-carboxamide. 3453 N-BUTYL SULFIDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3454 N-GLUCONYL ETHANOLAMINE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3455 N-HEXYL 2-BUTENOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3456 N-NONYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3457 NAPHTHALENE H Only for use as an active homoeopathic ingredient. 3458 NARDOSTACHYS CHINENSIS A, H 3459 NARINGIN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3460 NASTURTIUM OFFICINALE A, E, H 3461 NATURAL FISH OIL A, E When therapeutic indications for this product are made against Vitamin A or colecalciferol (Vitamin D), they are mandatory components of natural fish oil. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) 'WARNING: If you are pregnant - or considering becoming pregnant - do not take vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].' NOTE: Position this warning at the beginning of the directions for use. - (VITA4) 'WARNING - When taken in excess of 3000 micrograms retinol equivalents - vitamin A can cause birth defects.' NOTE: Position this warning at the beginning of the directions for use. - (VITA3) 'The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.' When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D. 3462 NAUCLEA OFFICINALIS A, H 3463 NELUMBO NUCIFERA A, H 3464 NELUMBO NUCIFERA FLOWER WAX E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.1%. 3465 NEOHESPERIDIN-DIHYDROCHALCONE E The routes of administration for medicines that contain neohesperidin-dihydrochalcone must be limited to: (a) topical for dermal application; and (b) oral. When used in topical medicines for dermal application: (a) neohesperidin-dihydrochalcone must not be included in medicines intended for use in the eye or on damaged skin; and (b) the concentration of neohesperidin-dihydrochalcone in the medicine must not be more than 0.1%. When used in oral medicines: (a) the concentration in the medicine must not be more than 0.1%; and (b) the following warning statement (or words to that effect) is required on the medicine label: - (NTAKEN3) 'Not to be taken by children under 3 years old'. 3466 NEOMENTHOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3467 NEOPENTYL GLYCOL DIHEPTANOATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 25%. 3468 NEOPENTYL GLYCOL DIISOSTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 3469 NEOPENTYL GLYCOL DIOCTANOATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 8.1%. When the concentration of neopentyl glycol dioctanoate is greater than 5%, the medicine must not be intended for use on damaged skin. 3470 NEOPENTYL GLYCOL DIOCTANOATE/DIDECANOATE E Only for use in topical medicines for dermal application. 3471 NEOPICRORHIZA SCROPHULARIIFLORA A, H 3472 NEPETA CATARIA A, H Pulegone is a mandatory component of Nepeta cataria and must be declared in the application. The concentration of pulegone in the medicine must be no more than 4%. 3473 NERAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3474 NERIUM OLEANDER A, H The concentration of equivalent dry Nerium oleander in the product must be no more than 1mg/Kg or 1mg/L or 0.0001%. 3475 NEROL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3476 NEROL OXIDE E Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 3477 NEROLIDOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3478 NERONE E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 3479 NERYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3480 NERYL-ISO-BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3481 NICKEL H Only for use as an active homoeopathic ingredient. 3482 NICOTIANA TABACUM H Only for use as an active homoeopathic ingredient. 3483 NICOTINAMIDE A, E, H 3484 NICOTINAMIDE ASCORBATE A, E 3485 NICOTINAMIDE RIBOSIDE CHLORIDE A Ribose is a mandatory component of nicotinamide riboside chloride. Only permitted for use in medicines limited to oral routes of administration. The maximum recommended daily dose of the medicine must not provide more than 300 mg of nicotinamide riboside chloride. The following warning statement (or words to the same effect) is required on the medicine label: - (NTAKEN12) 'Not to be taken by children under 12 years old.' When the maximum recommended daily dose of the medicine provides greater than 230 mg of nicotinamide riboside chloride, the following warning statement is required on the medicine label: - (PREG) 'Not recommended for use during pregnancy or lactation'. 3486 NICOTINIC ACID A, E The medicine must contain no more than 100 mg of nicotinic acid per dosage unit. 3487 NIGELLA DAMASCENA A, H 3488 NIGELLA SATIVA A, E, H 3489 NITRIC ACID E, H The concentration of nitric acid in the medicine must be no more than 0.5%. 3490 NONADIENOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3491 NONANAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3492 NONANOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3493 NONFAT DRY MILK E, H 3494 NONIVAMIDE E Nonivamide must only be included in medicines when in combination with other permitted ingredients as a flavour or fragrance proprietary excipient formulation. The ingredient is not to be included in medicines intended for use in the eye. The total concentration of flavour proprietary excipient formulations containing nonivamide must not be more than 5% of the total medicine. The total concentration of fragrance proprietary excipient formulations containing nonivamide must not be more than 1% of the total medicine. 3495 NONOXINOL 10 E Only for use in topical medicines for dermal application. 3496 NONOXINOL 12 E For use in hand scrub formulations for healthcare professionals only. Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 3497 NONOXINOL 5 E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3498 NONOXINOL 9 E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 25%. 3499 NONYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3500 NOOTKATONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3501 NOPYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3502 NORDIHYDROGUAIARETIC ACID E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.3%. 3503 NOTOPTERYGIUM FORBESII A, H 3504 NOTOPTERYGIUM INCISIUM A, H 3505 NUPHAR JAPONICA A, H 3506 NUPHAR LUTEA A, H 3507 NUTMEG DRY A, E, H Safrole is a mandatory component of Nutmeg Dry. When for internal use then the concentration of safrole from all ingredients in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole from all ingredients in the medicine must be no more than 1%. 3508 NUTMEG OIL A, E, H Safrole is a mandatory component of Nutmeg oil. When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%. When the concentration of Nutmeg oil in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, the medicine must have a restricted flow insert fitted on the container and requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). 3509 NUTMEG POWDER A, E, H Safrole is a mandatory component of Nutmeg powder. When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%. 3510 NUX VOMICA DRY A, H Strychnine (of Strychnos spp.) is a mandatory component of Nux Vomica Dry. The concentration of in the medicine must be no more than 1mg/Kg or 1mg/L or 0.0001%. 3511 NUX VOMICA POWDER H Only for use as an active homoeopathic ingredient. Strychnine (of Strychnos spp.) is a mandatory component of Nux vomica powder. The concentration in the medicine must be no more than 1mg/Kg or 1mg/L or 0.0001%. 3512 NYCTANTHES ARBOR-TRISTIS A, H When the plant part is leaf: a) methyl salicylate is a mandatory component of Nyctanthes arbor-tristis; b) not to be included in medicines for use in the eye or on damaged skin; c) when used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%; d) when the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging; e) when the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is spray, the medicine does not require child resistant packaging if: - the delivery device is engaged into the container in such a way that prevents it from being readily removed; - direct suction through the delivery device results in delivery of no more than one dosage unit; and - actuation of the spray device is ergonomically difficult for young children to accomplish; f) the following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect); and g) when for use in topical medicines for dermal application: i) the concentration of methyl salicylate in the medicine must not be more than 25% ii) the following warning statements are required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less'; - (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect); - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect); iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label: - (IRRIT) 'If irritation develops, discontinue use'. 3513 NYLON E Only for use in topical medicines for dermal application. 3514 NYLON 6/12 E Only for use in topical medicines for dermal application. 3515 NYLON-12 E Only for use in topical medicines for dermal application. 3516 NYMPHAEA ALBA A, E, H 3517 NYMPHAEA CAERULEA E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine to be no more than 0.3%. Only for use in liquid extracts where the plant part is the flower and the solvent in 100% water. 3518 NYMPHAEA ODORATA A, H 3519 OAK CHIPS EXTRACT E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3520 OAKMOSS ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3521 OAT E, H Only for use as an active homoeopathic or excipient ingredient. Gluten is a mandatory component of Oat when the route of administration is other than topical and mucosal. 3522 OAT BRAN E Gluten is a mandatory component of Oat bran when the route of administration is other than topical and mucosal. 3523 OATMEAL COLLOIDAL A, E Gluten is a mandatory component of Oatmeal colloidal when the route of administration is other than topical and mucosal. 3524 OCIMENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3525 OCIMENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3526 OCIMUM BASILICUM A, E, H When the plant preparation is oil or distillate, Methyl chavicol, eugenol, methyleugenol and cineole are mandatory components of Ocimum basilicum. The concentration of methyleugenol in the medicine must not exceed 1%. When the concentration of Methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25 millilitres. When the concentration of Methyl chavicol in the medicine is more than 5% and the nominal capacity of the container is 25 millilitres or less, a restricted flow insert must be fitted on the container, and requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). When the concentration of cineole OR eugenol in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres and the following warning statements must be included on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. When the concentration of cineole OR eugenol in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container. When the concentration of cineole OR eugenol in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container. When the preparation is for topical use in the mouth, the preparation may not contain more than 5 millilitres of eugenol and the concentration of eugenol in the product must not be greater than 25%. 3527 OCIMUM KILIMANDSCHARICUM A, H Camphor is a mandatory component of Ocimum kilimandscharicum. In solid and semi solid preparations, the concentration of camphor must not be more than 12.5%. In liquid preparations, the nominal capacity of the container must not be more than 25 millilitres. In liquid preparations other than essential oils or distillates, the concentration of camphor must not be more than 2.5%. In essential oil or distillate preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect). In essential oil or distillate preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect). In essential oil or distillate preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect). 3528 OCIMUM MINIMUM A, H 3529 OCIMUM TENUIFLORUM A, H When the plant part is oil or distillate, eugenol is a mandatory component of Ocimum tenuiflorum. When the concentration of eugenol in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres and the following warning statements must be included on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. When the concentration of eugenol in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container. When the concentration of eugenol in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container. When the preparation is for topical use in the mouth, the preparation may not contain more than 5 mL of eugenol and the concentration of eugenol in the product must not be greater than 25%. 3530 OCOTEA ODORIFERA A, H Safrole is a mandatory component of Ocotea odorifera. When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%. 3531 OCTACOSANOL E 3532 OCTADECANAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3533 OCTADECENE/MA COPOLYMER E Only for use in topical medicines for dermal application. 3534 OCTAHYDRO-4,7-METHANO-3AH-INDENE-3A-CARBOXYLIC ACID, ETHYL ESTER E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3535 OCTAHYDROCOUMARIN E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3536 OCTAN-1-OL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3537 OCTANAL DIMETHYL ACETAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3538 OCTANOHYDROXAMIC ACID E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 3539 OCTANOIC ACID A, E When for topical use, the concentration in the medicine must be no more than 2% (w/w). When for excipient use, permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 3540 OCTENE-1 E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 3541 OCTOCRYLENE A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 3542 OCTOXINOL 10 E Only for use in topical medicines for dermal application. 3543 OCTYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3544 OCTYL CROTONATE E Octyl crotonate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing octyl crotonate must not be more than 1% of the total medicine. 3545 OCTYL HYDROXYSTEARATE E Only for use in topical medicines for dermal application. 3546 OCTYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3547 OCTYL ISONONANOATE E Only for use in topical medicines for dermal application. 3548 OCTYL METHOXYCINNAMATE A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 3549 OCTYL PALMITATE E Only for use in topical medicines for dermal application. 3550 OCTYL SALICYLATE A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 5%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 3551 OCTYL STEARATE E Only for use in topical medicines for dermal application. 3552 OCTYLBICYCLOHEPTENEDICARBOXIMIDE E Only for use in topical medicines for dermal application. The total concentration of octylbicycloheptenedicarboximide in the medicine must not be more than 10%. 3553 OCTYLDODECANOL E Only for use in topical medicines for dermal application. 3554 OCTYLDODECETH-25 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. Residual levels of 1,4-dioxane and ethylene oxide (and related substances) are to be kept below the level of detection. 3555 OCTYLDODECYL CITRATE CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 12%. 3556 OCTYLDODECYL NEOPENTANOATE E Only for use in topical medicines for dermal application. 3557 OCTYLDODECYL STEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 3558 OCTYLDODECYL XYLOSIDE E Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 1.5%. 3559 OENANTHATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3560 OENANTHE AQUATICA H Only for use as an active homoeopathic ingredient. The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material. 3561 OENANTHE CROCATA A, H The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material. 3562 OENOTHERA BIENNIS A, E, H 3563 OENOTHERA STRICTA A, H 3564 OKOUBAKA AUBREVILLEI A, H 3565 OLDENLANDIA DIFFUSA A, E, H 3566 OLEA EUROPAEA A, E, H 3567 OLEIC ACID E 3568 OLETH-10 E Only for use in topical medicines for dermal application. 3569 OLETH-2 E Only for use in topical medicines for dermal application. Dioxane and Ethylene oxide are mandatory components of Oleth-2. The concentration of Dioxane in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%. The concentration of Ethylene oxide in the medicine must be no more than 1 mg/kg or 1 mg/L or 0.0001%. 3570 OLETH-20 E Only for use in topical medicines for dermal application. 3571 OLETH-3 E Only for use in topical medicines for dermal application. 3572 OLETH-3 PHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.12%. 3573 OLETH-5 E Only for use in topical medicines for dermal application. 3574 OLEYL ALCOHOL E Only for use in topical medicines for dermal application. 3575 OLIBANUM OIL A, E, H 3576 OLIVE OIL A, E, H 3577 OMEGA-3 FISH OIL PHYTOSTEROL ESTERS A The medicine requires the following warning statement on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women (or words to that effect).' 3578 OMEGA-3-ACID ETHYL ESTERS 60 A Docosahexaenoic acid, docosapentaenoic acid and eicosapentaenoic acid are mandatory components of omega-3-acid ethyl esters 60. Only permitted for use in medicines that are for oral routes of administration. The maximum recommended daily dose of the medicine must not provide more than 3750 milligrams of docosahexaenoic acid, docosapentaenoic acid and eicosapentaenoic acid combined. The following warning statements are required on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect); - (ACOAG) 'Individuals taking anticoagulants should seek medical advice before taking this product' (or words to that effect); - (CHILD3) 'Use in children under 12 years is not recommended'; - (FOOD) 'To be taken with food' (or words to that effect). 3579 OMEGA-3-ACID ETHYL ESTERS 90 A Only for use in oral medicines. The maximum recommended daily dose of the medicine must not provide more than: a) 4000 mg of omega-3-acid ethyl esters 90; and b) 3750 mg EPA, DHA and DPA combined, when used alone or in combination with other sources of omega-3 fatty acids. The following warning statements (or words to the same effect) are required on the medicine label: - (ACOAG) 'Individuals taking anticoagulants should seek medical advice before taking this product.' - (FOOD) 'To be taken with food.' - (PREG) 'Not recommended for use during pregnancy or lactation.' - (CHILD3) 'Use in children under 12 years is not recommended.' 3580 ONION E 3581 ONION OIL A, H 3582 ONONIS SPINOSA A, E, H 3583 ONOPORDUM ACANTHIUM A, H 3584 ONOSMODIUM VIRGINIANUM A, H 3585 OPHIOPOGON JAPONICUS A, H 3586 OPOPANAX CHIRONIUM A, E, H When used as an excipient, permitted for use only in combination with other permitted ingredients as part of a flavour or a fragrance proprietary excipient formulation. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3587 OPOPANAX OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3588 OPUNTIA FICUS-INDICA A, H 3589 ORANGE E 3590 ORANGE FLOWER ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3591 ORANGE FLOWER OIL A, E, H When used internally, oxedrine is a mandatory component of orange flower oil. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. 3592 ORANGE JUICE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3593 ORANGE JUICE OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3594 ORANGE OIL A, E, H When used internally, oxedrine is a mandatory component of orange oil. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. 3595 ORANGE OIL BITTER E Orange oil bitter must only be included in medicines when in combination with other permitted ingredients as a flavour or fragrance proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing orange oil bitter must not be more than 5% of the total medicine. The total concentration of fragrance proprietary excipient formulations containing orange oil bitter must not be more than 1% of the total medicine. The warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' or words to that effect must be included on the medicine label unless the medicine is: a) for internal use; b) in preparations containing 1.4% or less of orange oil bitter; or c) for use in soaps or bath or shower gels that are washed off the skin. 3596 ORANGE OIL BITTER COLDPRESSED A, E, H When used internally, oxedrine is a mandatory component of orange oil bitter coldpressed. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. The warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) in preparations containing 1.4% or less of orange oil bitter coldpressed; or c) for use in soaps or bath or shower gels that are washed off the skin. 3597 ORANGE OIL COLD PRESSED E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3598 ORANGE OIL DISTILLED A, E, H When used internally, oxedrine is a mandatory component of orange oil distilled. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. 3599 ORANGE OIL SWEET E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3600 ORANGE OIL TERPENELESS A, E, H When used internally, oxedrine is a mandatory component of orange oil terpeneless. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. 3601 ORANGE PEEL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3602 ORANGE PEEL DRIED BITTER A, E, H When used internally, oxedrine is a mandatory component of orange peel dried bitter. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. 3603 ORANGE PEEL OIL SWEET TERPENELESS E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3604 ORANGE ROUGHY OIL E Only for use in topical medicines for dermal application. 3605 ORIGANUM MAJORANA A, H Beta-arbutin is a mandatory component of Origanum majorana. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. When the plant preparation is oil or distillate, and the concentration of Origanum majorana oil or distillate within the medicine is more than 50%: a) the nominal capacity of the container must not be more than 50 mL; b) a restricted flow insert must be fitted on the container; and c) the following warning statement is required on the label: - (CHILD) 'Keep out of reach of children' (or words to that effect). 3606 ORIGANUM OIL E Permitted for use only in combination with other ingredients as a fragrance. If used as a fragrance the total concentration in the medicine must be no more than 1%. 3607 ORIGANUM OIL SPANISH A, E, H 3608 ORIGANUM VULGARE A, E, H 3609 ORNITHINE A, E 3610 ORNITHINE ASPARTATE A, E 3611 ORNITHINE MONOHYDROCHLORIDE A, E 3612 ORNITHOGALUM UMBELLATUM A, H 3613 OROSTACHYS FIMBRIATA A, H 3614 OROXYLUM INDICUM A, H 3615 ORRIS E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3616 ORRIS CONCRETE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3617 ORRIS ROOT EXTRACT E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3618 ORRIS ROOT OIL A, E, H 3619 ORRIS ROOT RESIN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3620 ORTHO-TERT-BUTYLCYCLOHEXYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3621 ORTHOSIPHON ARISTATUS A, H 3622 ORYZA SATIVA A, E, H 3623 ORYZANOL E 3624 OSBECKIA CHINENSIS A, H 3625 OSMANTHUS ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3626 OSMANTHUS FRAGRANS E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3627 OTTELIA ALISMOIDES A, H 3628 OXACYCLOHEPTADEC-11-EN-2-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3629 OXACYCLOHEXADECAN-2-ONE E Only for use in topical medicines for dermal application. 3630 OXACYCLOHEXADECEN-2-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3631 OXALIC ACID H Only for use as an active homoeopathic ingredient. The total concentration of oxalic acid in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 3632 OXALIS ACETOSELLA A, H 3633 OXIDISED MAIZE STARCH E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3634 OXIDISED TAPIOCA STARCH E 3635 OXYBENZONE A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 3636 OYSTER E The following warning statement is required on the medicine label: - (MOLLUSC) 'Contains mollusc' or 'Contains mollusc products'. 3637 OYSTER SHELL A, E, H The following warning statement is required on the medicine label: - (MOLLUSC) 'Contains mollusc' or 'Contains mollusc products'. Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine Note: See sections 5 and 6. Permissible ingredients and requirements Column 1 Column 2 Column 3 Column 4 Item Ingredient name Purpose Specific requirements 3638 P-ALPHA-DIMETHYL STYRENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3639 P-ANISIC ACID E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.3%. 3640 PADIMATE O A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 8%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 3641 PADINA PAVONICA THALLUS PHYTOSTEROLS E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.01%. 3642 PAEONIA LACTIFLORA A, E, H 3643 PAEONIA OBOVATA A, H 3644 PAEONIA SUFFRUTICOSA A, E, H 3645 PAEONIA VEITCHII A, H 3646 PALIURUS SPINA-CHRISTI A, H 3647 PALLADIUM H Only for use as an active homoeopathic ingredient. 3648 PALM FRUIT OIL A, E, H 3649 PALM GLYCERIDES E 3650 PALM KERNEL OIL A, E, H 3651 PALM TOCOTRIENOLS COMPLEX A, H 3652 PALMARIA PALMATA A, H 3653 PALMAROSA OIL A, E, H 3654 PALMIDROL A Only permitted for use in medicines limited to oral routes of administration. The maximum recommended daily dose of the medicine must not provide more than 600 mg of palmidrol. The following warning statements (or words to the same effect) are required on the medicine label: - (ANALG) 'The medicine may interact with other prescription analgesic medicines, please consult your healthcare practitioner before use.' - (ADULT) 'Adults only.' - (21DAYS) 'Not to be used for more than 21 consecutive days.' 3655 PALMITIC ACID E 3656 PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS A 3657 PALMITOYL DIPEPTIDE-7 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.002%. 3658 PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.01% 3659 PALMITOYL OLIGOPEPTIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.002%. 3660 PALMITOYL PENTAPEPTIDE-3 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.0005%. 3661 PALMITOYL TETRAPEPTIDE-3 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.001%. 3662 PANAX GINSENG A, E, H 3663 PANAX JAPONICUS A, H 3664 PANAX NOTOGINSENG A, H 3665 PANAX PSEUDOGINSENG A, H 3666 PANAX QUINQUEFOLIUS A, H 3667 PANICUM MILIACEUM A, H 3668 PANTETHINE E Only for use in topical medicines for dermal application. 3669 PANTHENOL A, E 3670 PANTHENYL ETHYL ETHER E Only for use in topical medicines for dermal application. 3671 PANTOLACTONE E 3672 PANTOTHENIC ACID A, E When used topically, the concentration in the medicine must be no more than 0.1%. 3673 PANTOTHENIC ACID POLYPEPTIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 3674 PAPAIN A, E 3675 PAPER E Only for use in topical medicines for dermal application. 3676 PAPRIKA OLEORESIN E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3677 PARA-CRESOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3678 PARA-CRESYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3679 PARA-CRESYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3680 PARA-CRESYL PHENYLACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3681 PARA-CYMENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3682 PARA-ETHOXYBENZALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3683 PARA-ETHYL CRESOXYACETATE E Para-ethyl cresoxyacetate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing para-ethyl cresoxyacetate must not be more than 1% of the total medicine. 3684 PARA-ETHYLPHENOL E Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The maximum recommended daily dose must contain no more than 0.12 mg of para-ethylphenol. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. 3685 PARA-HYDROXY BENZALACETONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3686 PARA-HYDROXYBENZOIC ACID E 3687 PARA-MENTHA-8-THIOL-3-ONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3688 PARA-METHYL ACETOPHENONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3689 PARA-METHYL ANISOLE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3690 PARA-METHYL DIMETHYLBENZYL CARBINOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3691 PARA-PROPYL ANISOLE E Para-propyl anisole must only be included in medicines when in combination with other permitted ingredients as a fragrance and/or flavour proprietary excipient formulation. The total concentration of fragrance proprietary excipient formulations containing para-propyl anisole must not be more than 1% of the total medicine. The total concentration of flavour proprietary excipient formulations containing para-propyl anisole must not be more than 5% of the total medicine. 3692 PARA-TERT-BUTYLCYCLOHEXYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3693 PARA-TERT-BUTYLPHENYL-ALPHA-METHYLHYDROCINNAMIC ALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3694 PARA-TOLUALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3695 PARA-TOLYL ACETALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3696 PARAMERIA LAEVIGATA A, H 3697 PARIETARIA JUDAICA A, H 3698 PARIS POLYPHYLLA A, H 3699 PARIS QUADRIFOLIA A, H 3700 PARSLEY HERB DRY A, E, H The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. The following warning statement is required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant.' unless when: (a) parsley herb dry is used as an active homoeopathic ingredient at a homoeopathic potency of more than 12X; or (b) parsley herb dry is used as an excipient in a flavour where the total concentration of flavour proprietary excipient formulations containing parsley herb dry must not be more than 5% of the total medicine; or (c) parsley herb dry is used as an excipient in a fragrance where the total concentration of fragrance proprietary excipient formulations containing parsley herb dry must not be more than 1% of the total medicine. 3701 PARSLEY HERB OIL A, E, H The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. The following warning statement is required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant.' unless when: (a) parsley herb oil is used as an active homoeopathic ingredient at a homoeopathic potency of more than 12X; or (b) parsley herb oil is used as an excipient in a flavour where the total concentration of flavour proprietary excipient formulations containing parsley herb oil must not be more than 5% of the total medicine; or (c) parsley herb oil is used as an excipient in a fragrance where the total concentration of fragrance proprietary excipient formulations containing parsley herb oil must not be more than 1% of the total medicine. 3702 PARSLEY HERB POWDER A, E, H The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. The following warning statement is required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant.' unless when: (a) parsley herb powder is used as an active homoeopathic ingredient at a homoeopathic potency of more than 12X; or (b) parsley herb powder is used as an excipient in a flavour where the total concentration of flavour proprietary excipient formulations containing parsley herb powder must not be more than 5% of the total medicine; or (c) parsley herb powder is used as an excipient in a fragrance where the total concentration of fragrance proprietary excipient formulations containing parsley herb powder must not be more than 1% of the total medicine. 3703 PARSLEY SEED OIL A, E, H The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. The following warning statement is required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant.' unless when: (a) parsley seed oil is used as an active homoeopathic ingredient at a homoeopathic potency of more than 12X; or (b) parsley seed oil is used as an excipient in a flavour where the total concentration of a flavour proprietary excipient formulations containing parsley seed oil must not be more than 5% of the total medicine; or (c) parsley seed oil is used as an excipient in a fragrance where the total concentration of fragrance excipient formulations containing parsley seed oil must not be more than 1% of the total medicine. 3704 PARTHENOCISSUS TRICUSPIDATA A, H 3705 PARTIALLY DEHYDRATED LIQUID SORBITOL E Sorbitol is a mandatory component of partially dehydrated liquid sorbitol. Permitted for use only as part of the capsule in medicines where the dosage form is a soft capsule. 3706 PARTIALLY HYDROGENATED SOYA OIL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in the medicine must be no more than 5%. 3707 PARTIALLY REFINED PORPHYRA YEZOENSIS CYTOPLASM EXTRACT E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.00002%. 3708 PASPALUM NOTATUM A, H 3709 PASSIFLORA CAERULEA A, H 3710 PASSIFLORA EDULIS E 3711 PASSIFLORA HERB DRY A, H 3712 PASSIFLORA INCARNATA A, E, H 3713 PATCHOULI OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3714 PATENT BLUE V E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 3715 PATENT BLUE V ALUMINIUM LAKE E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 3716 PATRINIA SCABIOSIFOLIA A, H 3717 PATRINIA VILLOSA A, H 3718 PAULLINIA CUPANA A, E, H Caffeine is a mandatory component of Paullinia cupana. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: - (ADULT) 'Adults only' (or words to that effect). - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.' - (CAFFPREG) 'Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.' When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.' - (CAFFCYP) 'Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines' (or words to that effect). 3719 PAULLINIA PINNATA A, H 3720 PAWPAW E 3721 PEA E 3722 PEA STARCH E 3723 PEACH E 3724 PEAR E 3725 PECAN E 3726 PECTIN A, E 3727 PEG-10 DIMETICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or damaged skin. The concentration in the medicine must be no more than 4.0%. 3728 PEG-10 SOYA STEROL E Only for use in topical medicines for dermal application. 3729 PEG-100 STEARATE E Only for use in topical medicines for dermal application. 3730 PEG-12 DILAURATE E 3731 PEG-12 DIMETICONE/PPG-20 CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. 3732 PEG-120 METHYL GLUCOSE DIOLEATE E Only for use in topical medicines for dermal application. 3733 PEG-120 STEARATE E Only for use in topical medicines for dermal application. 3734 PEG-15 COCAMINE E Only for use in topical medicines for dermal application. 3735 PEG-150 DISTEARATE E Only for use in topical medicines for dermal application. 3736 PEG-20 ALMOND GLYCERIDES E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 3737 PEG-20 METHYL GLUCOSE DISTEARATE E Only for use in topical medicines for dermal application. 3738 PEG-20 METHYL GLUCOSE SESQUISTEARATE E Only for use in topical medicines for dermal application. 3739 PEG-20 SORBITAN ISOSTEARATE E Only for use in topical medicines for dermal application. 3740 PEG-20 STEARATE E Only for use in topical medicines for dermal application. 3741 PEG-25 PABA A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 3742 PEG-30 DIPOLYHYDROXYSTEARATE E Only for use in topical medicines for dermal application. 3743 PEG-30 STEARATE E Only for use in topical medicines for dermal application. 3744 PEG-35 CASTOR OIL E 3745 PEG-4 DILAURATE E Only for use in topical medicines for dermal application. 3746 PEG-4 LAURATE E Only for use in topical medicines for dermal application. Dioxane and Ethylene oxide are mandatory components of PEG-4 laurate. The concentration of Dioxane in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%. The concentration of Ethylene oxide in the medicine must be no more than 1 mg/kg or 1 mg/L or 0.0001%. 3747 PEG-4 STEARATE E Only for use in topical medicines for dermal application. 3748 PEG-40 CASTOR OIL E 3749 PEG-40 HYDROGENATED CASTOR OIL E 3750 PEG-40 SORBITAN DIISOSTEARATE E Only for use in topical medicines for dermal application. Dioxane and Ethylene oxide are mandatory components of PEG-40 sorbitan diisostearate. The concentration of Dioxane in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%. The concentration of Ethylene oxide in the medicine must be no more than 1 mg/kg or 1 mg/L or 0.0001%. 3751 PEG-40 STEARATE E Only for use in topical medicines for dermal application. 3752 PEG-45/DODECYL GLYCOL COPOLYMER E Only for use in topical medicines for dermal application. 3753 PEG-5 GLYCERYL STEARATE E Only for use in topical medicines for dermal application. 3754 PEG-50 STEARATE E Only for use in topical medicines for dermal application. 3755 PEG-55 PROPYLENE GLYCOL OLEATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.6%. 3756 PEG-6 LAURAMIDE E Only for use in topical medicines for dermal application. 3757 PEG-60 ALMOND GLYCERIDES E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration when used in medicines applied directly to the skin must be no more than 10%. The concentration when used in bath oil medicines must be no more than 30%. 3758 PEG-60 GLYCERYL ISOSTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 3759 PEG-60 HYDROGENATED CASTOR OIL E Only for use in topical medicines for dermal application. 3760 PEG-7 COCAMIDE E Only for use in topical medicines for dermal application. 3761 PEG-7 GLYCERYL COCOATE E Only for use in topical medicines for dermal application. 3762 PEG-7 HYDROGENATED CASTOR OIL E Only for use in topical medicines for dermal application. 3763 PEG-75 LANOLIN E Only for use in topical medicines for dermal application. 3764 PEG-75 STEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%. 3765 PEG-8 CETYL DIMETHICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.0005%. 3766 PEG-8 DILAURATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. 3767 PEG-8 DISTEARATE E Only for use in topical medicines for dermal application. 3768 PEG-8 LAURATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. The levels of possible impurities such as ethylene oxide (and related material) must be kept below the level of detection. 3769 PEG-8 PROPYLENE GLYCOL COCOATE E 3770 PEG-8 STEARATE E Only for use in topical medicines for dermal application. 3771 PEG-9 POLYDIMETHYLSILOXYETHYL DIMETICONE E Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 3.5%. 3772 PEG/PPG-14/7 DIMETHYL ETHER E Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 7%. 3773 PEG/PPG-18/18 DIMETHICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 3774 PELARGONIUM GRAVEOLENS A, E, H 3775 PELLITORINE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3776 PELTIGERA CANINA A, H 3777 PENICILLIUM EXPANSUM A, H 3778 PENNYROYAL OIL E D-Pulegone/Pulegone is a mandatory component of Pennyroyal Oil. The concentration of D Pulegone/ Pulegone in the medicine must be no more than 4%. Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in the medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in the medicine must be no more than 1%. When the medicine is for a use other than topical, the maximum recommended daily dose must be no more than 50 mg of Pennyroyal Oil. 3779 PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.018% 3780 PENTAERYTHRITYL TETRAISOSTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 61%. 3781 PENTAERYTHRITYL TETRALAURATE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 80%. 3782 PENTAMETHYLHEPTENONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3783 PENTANE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3784 PENTASODIUM ETHYLENEDIAMINE TETRAMETHYLENE PHOSPHONATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 3785 PENTYLENE GLYCOL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 3786 PEPPER BLACK E, H 3787 PEPPER OIL TERPENELESS E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3788 PEPPERMINT AMERICAN EXT. E Menthol is a mandatory component of peppermint american ext. When the medicine is for topical use for dermal application: a) the medicine must not be intended for use in the eye or on damaged skin; b) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; c) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). d) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. e) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3789 PEPPERMINT LEAF DRY A, E, H Menthol is a mandatory component of peppermint leaf dry. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3790 PEPPERMINT LEAF POWDER A, E, H Menthol is a mandatory component of peppermint leaf powder. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3791 PEPPERMINT OIL A, E, H Menthol is a mandatory component of peppermint oil. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3792 PEPPERMINT OIL TERPENELESS E Permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation or fragrance proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. The total fragrance proprietary excipient formulation in a medicine must be no more 1%. Menthol is a mandatory component of peppermint oil terpeneless. When the medicine is for topical use for dermal application: i) the medicine must not be intended for use in the eye or on damaged skin; ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3793 PEPPERMINT OIL TERPENES AND TERPENOIDS E Permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. Menthol is a mandatory component of peppermint oil terpenes and terpenoids. When the medicine is for topical use for dermal application: i) the medicine must not be intended for use in the eye or on damaged skin; ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 3794 PERFLUOROPOLYMETHYLISOPROPYL ETHER E Only for use in topical medicines for dermal application. 3795 PERHYDRO-3,6-DIMETHYL-BENZO [B] FURAN-2-ONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3796 PERILLA FRUTESCENS A, E, H 3797 PERILLALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3798 PERLITE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 3799 PERMETHRIN E The total concentration of permethrin in the medicine must not be more than 2%. 3800 PERSEA AMERICANA A, E, H 3801 PERSIC OIL A, E, H Amygdalin and Hydrocyanic acid are mandatory components of Persic oil. The concentration of amygdalin in the medicine must be no more than 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 3802 PERSICARIA CHINENSIS A, H 3803 PERSICARIA TINCTORIA A, H 3804 PERU BALSAM A, E, H 3805 PERU BALSAM OIL A, E, H 3806 PETITGRAIN MANDARIN OIL E Permitted for use only in combination with other permitted ingredients as a flavour The final concentration of the oil in the flavour does not exceed 30% If used in a flavour the total flavour concentration in a medicine must be no more than 5% 3807 PETITGRAIN OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3808 PETITGRAIN OIL CITRONNIER E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. When included in a medicine for use on the lips the concentration of petitgrain oil citronnier must be no more than 0.1%. When included in dermal creams for infant use the concentration of petitgrain oil citronnier must be no more than 0.5% The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 3809 PETITGRAIN OIL PARAGUAY A, E, H When used internally, oxedrine is a mandatory component of petitgrain oil paraguay. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. 3810 PETITGRAIN OIL TERPENELESS E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3811 PETROSELINUM CRISPUM A, E, H The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. The following warning statement is required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant.' unless when: (a) Petroselinum crispum is used as an active homoeopathic ingredient at a homoeopathic potency of more than 12X; or (b) Petroselinum crispum is used as an excipient where the total concentration of flavour proprietary excipient formulations containing Petroselinum crispum must not be more than 5% of the total medicine; or (c) Petroselinum crispum is used as an excipient in a fragrance where the total concentration of fragrance proprietary excipient formulations containing Petroselinum crispum must not be more than 1% of the total medicine. 3812 PEUCEDANUM PRAERUPTORUM A, E, H 3813 PEUMUS BOLDUS A, H Volatile oil components (of Peumus boldus) is a mandatory component. The maximum recommended daily dose must be no more than 100 mg of volatile oil components (of Peumus boldus). 3814 PHALARIS ARUNDINACEA A, H 3815 PHALARIS CANARIENSIS A, H 3816 PHASEOLUS COCCINEUS A, H 3817 PHASEOLUS VULGARIS A, H 3818 PHELLINUS ROBINIAE A, E, H 3819 PHELLODENDRON AMURENSE A, E, H 3820 PHELLODENDRON CHINENSE A, H 3821 PHENACETIN E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%. 3822 PHENETHYL 2-METHYLBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3823 PHENETHYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3824 PHENETHYL ALCOHOL E Permitted for use only: a) in topical medicines for dermal application; and b) for internal use in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation concentration in a medicine must be no more than 5%. 3825 PHENETHYL BENZOATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 6%. 3826 PHENETHYL DIMETHICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2% 3827 PHENETHYL ISOAMYL ETHER E Permitted for use only in combination with other permitted ingredients as a fragrance. If used as in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3828 PHENETHYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3829 PHENETHYL ISOVALERATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3830 PHENETHYL PHENYLACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3831 PHENETHYL SALICYLATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3832 PHENOL E Only for use in topical medicines for dermal application. The concentration of phenol in the medicine must be no more than 1%. 3833 PHENOXYACETALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3834 PHENOXYETHANOL E The requirements specified in paragraphs (a) to (b) below apply to a medicine that contains the ingredient that is: - listed in the Register before 1 March 2025; and - released for supply before 1 March 2026. (a) Only for use in topical medicines for dermal application. (b) The concentration of phenoxyethanol in the preparation must not exceed 15%. The requirements specified in paragraphs (c) to (d) below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. (c) Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. (d) The concentration of phenoxyethanol in the preparation must not exceed 1%. 3835 PHENOXYETHYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3836 PHENOXYETHYLPARABEN E Only for use in topical medicines for dermal application. 3837 PHENYL DIMETHICONE E Only for use in topical medicines for dermal application. 3838 PHENYL TRIMETHICONE E Only for use in topical medicines for dermal application. 3839 PHENYLACETALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3840 PHENYLACETALDEHYDE DIMETHYL ACETAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3841 PHENYLACETALDEHYDE GLYCERYLACETAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3842 PHENYLACETIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3843 PHENYLALANINE A, E When the maximum recommended daily dose of the medicine provides more than 500 mg phenylalanine, the following warning statement is required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant'. 3844 PHENYLBENZIMIDAZOLE SULFONIC ACID A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 4%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 3845 PHENYLETHYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3846 PHENYLETHYL CAPROATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3847 PHENYLETHYL CAPRYLATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3848 PHENYLETHYL CINNAMATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3849 PHENYLETHYL FORMATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3850 PHENYLETHYL METHYLETHYL CARBINOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3851 PHENYLETHYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3852 PHENYLETHYL TIGLATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3853 PHENYLISOPROPYL DIMETICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 3854 PHENYLPROPANOL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.16%. 3855 PHLEUM PRATENSE A, H Only permitted in preparations other than phleum pratense pollen extract. 3856 PHLOXINE B E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 3857 PHLOXINE B ALUMINIUM LAKE E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 3858 PHOENIX DACTYLIFERA A, E, H 3859 PHOSPHATIDYL CHOLINE E 3860 PHOSPHOLIPIDS E Only for use in topical medicines for dermal application and not intended for use in the eye. The concentration in the medicine must be no more than 20%. 3861 PHOSPHORIC ACID E, H The concentration in liquid medicines must be no more than 15%. 3862 PHOSPHORUS H Only for use as an active homoeopathic ingredient. The total concentration of phosphorus in the medicine must not be more than 1 mg/kg or 1 mg/L or 0.0001%. 3863 PHOTINIA SERRULATA A, H 3864 PHRAGMITES AUSTRALIS A, H 3865 PHYLLANTHUS AMARUS A, H 3866 PHYLLANTHUS EMBLICA A, E, H When used as an excipient, only for use in topical medicines for dermal application. 3867 PHYLLOSTACHYS NIGRA A, E, H 3868 PHYSALIS ALKEKENGI A, H 3869 PHYSALIS PUBESCENS A, H 3870 PHYTANTRIOL E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.5%. 3871 PHYTOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3872 PHYTOLACCA AMERICANA A, H The maximum recommended daily dose of the medicine must contain no more than 1mg of the equivalent dry herb. 3873 PHYTOMENADIONE A, E 3874 PHYTOSPHINGOSINE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 3875 PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 3876 PICEA ABIES A, H 3877 PICEA MARIANA A, H 3878 PICRASMA EXCELSA A, E, H 3879 PICRORRHIZA KURROA A, E, H 3880 PIGMENT BLUE 15 E Permitted for use only as a colour for topical and dental use. The concentration in medicine must be no more than 0.003%. 3881 PIGMENT BLUE 15:1 E Permitted for use only as a colour for topical use. Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.21%. 3882 PIGMENT GREEN 7 E Permitted for use only as a colour for topical and dental use. When for dental use, the concentration in the medicine must be no more than 0.003%. When for topical use, the concentration in the medicine must be no more than 0.17%. 3883 PIGMENT RED 4 E Permitted for use only as a colour for topical use. 3884 PIGMENT RED 53 E Permitted for use only as a colour for topical use. 3885 PIGMENT RED 57 E Permitted for use only as a colour for topical use. 3886 PIGMENT RED 57 ALUMINIUM LAKE E Permitted for use only as a colour for topical use. 3887 PIGMENT RED 57 BARIUM LAKE E Permitted for excipient use as a colour in topical medicines for dermal application. Not to be included in medicines intended for use in the eye. 3888 PIGMENT RED 63 E Permitted for use only as a colour for topical use. 3889 PIGMENT WHITE 26 E Permitted for use only as a colour for topical use. 3890 PIGMENT YELLOW 12 E Permitted for use only as a colour for topical use. 3891 PILOCARPUS JABORANDI A, H Pilocarpine is a mandatory component of Pilocarpus jaborandi. The concentration of pilocarpine in the medicine must be no more than 0.025%. 3892 PILOCARPUS MICROPHYLLUS A, H Pilocarpine is a mandatory component of Pilocarpus microphyllus. The concentration of pilocarpine in the medicine must be no more than 0.025%. 3893 PILOCARPUS PINNATIFOLIUS A, H Pilocarpine is a mandatory component of Pilocarpus pinnatifolius. The concentration of pilocarpine in the medicine must be no more than 0.025%. 3894 PIMENTA FRUIT OIL A, E, H 3895 PIMENTA LEAF OIL A, E, H 3896 PIMENTA OFFICINALIS A, E, H 3897 PIMENTA RACEMOSA A, E, H When the plant preparation for Pimenta racemosa is an oil and the concentration of this oil in the medicine is more than 25%, the nominal capacity of the container must be no more than 25 mL. When the plant preparation for Pimenta racemosa is an oil, the concentration of this oil in the medicine is more than 25%, and the nominal capacity of the container is more than 15 mL, a restricted flow insert must be fitted on the container. When the plant preparation for Pimenta racemosa is an oil, the concentration of this oil in the medicine is more than 25%, and the nominal capacity of the container is more than 15 mL but no more than 25 mL, a child resistant closure and restricted flow insert must be fitted on the container. The medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect) - (NTAKEN) 'Not to be taken'. 3898 PIMPINELLA ANISUM A, E, H When the plant preparation for Pimpinella anisum is an oil or distillate and the concentration of this oil or distillate in the medicine is more than 50%: a) the nominal capacity of the container must not be more than 50 millilitres; and b) a restricted flow insert must be fitted on the container; and c) the medicine requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). 3899 PIMPINELLA SAXIFRAGA A, E, H 3900 PINE NEEDLE OIL SCOTCH A, E, H 3901 PINE NEEDLE OIL TERPENELESS E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3902 PINE OIL AROMATIC A, E, H 3903 PINE OIL PUMILIO A, E, H 3904 PINEAPPLE E 3905 PINEAPPLE OILS E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3906 PINELLIA TERNATA A, H 3907 PINUS CONTORTA A, E, H 3908 PINUS ELLIOTTII E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5% If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3909 PINUS MASSONIANA A, E, H When the plant preparation is oil or distillate the total concentration of Pinus massoniana oil or distillate in the preparation must be no more than 25%. 3910 PINUS MONTICOLA A, E, H 3911 PINUS MUGO A, E, H 3912 PINUS PALUSTRIS E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3913 PINUS PINASTER A, E, H When the plant preparation is oil or distillate the total concentration of Pinus pinaster oil or distillate in the preparation must be no more than 25%. 3914 PINUS PONDEROSA A, E, H 3915 PINUS RADIATA A, E, H 3916 PINUS STROBUS A, E, H 3917 PINUS SYLVESTRIS A, E, H 3918 PINUS TABULIFORMIS A, E, H 3919 PINUS YUNNANENSIS E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3920 PIPENZOLATE BROMIDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3921 PIPER CHABA A, E, H 3922 PIPER CUBEBA A, E, H 3923 PIPER KADSURA A, E, H 3924 PIPER LONGUM A, E, H 3925 PIPER METHYSTICUM A, H Kavalactones (of Piper methysticum) is a mandatory component of Piper methysticum. Only for oral use when the dosage form is 'tablet' or 'capsule'; or when the container type is 'tea bag'. When used in oral medicines, the maximum daily dose of kavalactones (of Piper methysticum) must be no more than 250 mg. If the dosage form is tablet or capsule then the quantity of kavalactones (of Piper methysticum) must be no more than 125 mg per tablet or capsule. Oral medicines containing more than 25 mg of kavalactones (of Piper methysticum) per dose require the following warning statement on the medicine label: - (PIPER) 'Not for prolonged use. If symptoms persist - seek advice from a healthcare practitioner. Not recommended for pregnant or lactating women (or words to that effect). May harm the liver'. The plant part must be root or rhizome. When for oral use, the medicine may only contain dried whole or peeled root or rhizome or aqueous dispersions or aqueous extracts of whole or peeled root or rhizome. When for topical use on the rectum, vagina or throat, the medicine may only contain dried whole or peeled root or rhizome or aqueous dispersions or aqueous extracts of whole or peeled root or rhizome. When the container type is tea bag the maximum quantity per tea bag must be no more than 3 grams of dried whole or peeled root or rhizomes. 3926 PIPER NIGRUM A, E, H 3927 PIPER SARMENTOSUM A, E, H 3928 PIPERINE E Permitted for use only in combination with other permitted ingredients as a flavour proprietary formulation. The total flavour proprietary formulation in a medicine must not be more than 5% and the concentration of piperine in the medicine must not be more than 0.15%. 3929 PIPERITONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 3930 PIPERONAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 3931 PIPERONYL ACETONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. If used as in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3932 PIPERONYL BUTOXIDE E Only for use in topical medicines for dermal application. 3933 PIROCTONE OLAMINE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1% in wash-on/wash-off medicines and 0.5% in leave-on medicines. 3934 PISCIDIA PISCIPULA A, E, H 3935 PISTACIA LENTISCUS A, E, H 3936 PISUM SATIVUM A, E, H 3937 PLACENTA H Only for use as an active homoeopathic ingredient. 3938 PLANTAGO AFRA A, E, H When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect). 3939 PLANTAGO ARENARIA A, H When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect). 3940 PLANTAGO ASIATICA A, H When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect). 3941 PLANTAGO LANCEOLATA A, E, H The medicine requires the following warning statement on the medicine label: - (CHILD5) 'Use in children under 3 years is not recommended' When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect). 3942 PLANTAGO MAJOR A, E, H When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect). 3943 PLANTAGO OVATA A, H When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect). 3944 PLANTAGO SEED DRY A, H When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect). 3945 PLATANUS OCCIDENTALIS A, E, H 3946 PLATANUS RACEMOSA A, H 3947 PLATANUS × HISPANICA A, H 3948 PLATYCODON GRANDIFLORUS A, E, H 3949 PLECTRANTHUS BARBATUS A, E, H 3950 PLICATONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3951 PLUM E 3952 PLUMBAGO EUROPAEA A, H 3953 PLUMERIA ALBA A, E, H 3954 PLUMERIA RUBRA A, E, H 3955 POA NEMORALIS A, H 3956 POA PRATENSIS A, H 3957 PODOPHYLLUM PELTATUM A, H Podophyllin and podophyllotoxin are mandatory components of Podophyllum peltatum. The concentration of podophyllin in the medicine must be no more than 1 mg/kg or 1 mg/L or 0.0001%. The concentration of podophyllotoxin in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%. 3958 POGOSTEMON CABLIN A, E, H 3959 POLACRILIN E 3960 POLACRILIN POTASSIUM E 3961 POLAPREZINC A Only for use in oral medicines. Zinc is a mandatory component of Polaprezinc. The maximum recommended daily dose must be no more than 34 milligrams of zinc sourced from polaprezinc. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period' (or words to that effect). 3962 POLIGLUSAM A, E The average molecular mass of poliglusam must be greater than 2 kilodaltons. When for internal use: (a) the maximum recommended daily dose of the medicine must not provide more than 1750 milligrams poliglusam; and (b) the following warning statement is required on the medicine label: - (CHITO) 'Poliglusam should be taken at least one hour after any other medication as it may reduce the effect of other medication' (or words to that effect). When for internal use and the dosage form is a powdered preparation, the following warning statement is required on the medicine label: - (DNTPOW) 'Do not take powder alone. Mix with food or fluid'. When used as an excipient, only for use in topical medicines for dermal application. 3963 POLIGLUSAM DERIVED FROM ASPERGILLUS NIGER A, E When for oral use: (a) the maximum recommended daily dose of the medicine must not provide more than 2000 mg of Poliglusam derived from Aspergillus niger; (b) the following warning statement (or words to the same effect) is required on the medicine label: - (CHITO) 'Poliglusam should be taken at least one hour after any other medication as it may reduce the effect of other medication.'; and (c) if the medicine is a powdered dosage form, the following warning statement is also required on the medicine label: - (DNTPOW) 'Do not take powder alone. Mix with food or fluid.' When used as an excipient, Poliglusam derived from Aspergillus niger is only permitted for use in topical medicines for dermal application. 3964 POLLACK-LIVER OIL A, E Colecalciferol and Vitamin A are mandatory components of Pollack-liver oil. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) 'WARNING: If you are pregnant - or considering becoming pregnant - do not take vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].' NOTE: Position this warning at the beginning of the directions for use. - (VITA4) 'WARNING - When taken in excess of 3000 micrograms retinol equivalents - Vitamin A can cause birth defects.' NOTE: Position this warning at the beginning of the directions for use. - (VITA3) 'The recommended daily amount of Vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.' When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D. 3965 POLLEN E The medicine requires the following warning statement on the medicine label: - (POLLEN) 'This medicine can cause severe allergic reactions' (or words to that effect). 3966 POLOXAMER E Only for use in topical medicines for dermal application. 3967 POLOXAMINE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 3968 POLY C10-30 ALKYL ACRYLATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 3969 POLYACRYLAMIDE E Only for use in topical medicines for dermal application. Acrylamide is a mandatory component of Polyacrylamide. The concentration of Acrylamide in the medicine must be no more than 0.01%. 3970 POLYACRYLATE CROSSPOLYMER-6 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. 3971 POLYACRYLATE DISPERSION (30 PER CENT) E Methyl methacrylate is a mandatory component of polyacrylate dispersion (30 per cent). The total concentration of methyl methacrylate as residual monomer in the medicine must not be more than 1%. The route of administration for medicines that contain polyacrylate dispersion (30 per cent) must be limited to oral use. Polyacrylate dispersion (30 per cent) is not permitted for use in children under the age of 4 years. The maximum recommended daily dose of the medicine must not provide more than: a) 1.33 grams of polyacrylate dispersion (30 per cent) to individuals aged 4 to 17 years (inclusive); and b) 4.67 grams of polyacrylate dispersion (30 per cent) to individuals aged 18 years and above. 3972 POLYACRYLATE-1 CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.4%. 3973 POLYACRYLIC ACID E 3974 POLYAMINO SUGAR CONDENSATE E Only for use in topical medicines for dermal application. 3975 POLYAMINOPROPYL BIGUANIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.3%. 3976 POLYBUTADIENE E Only for use as part of an adhesive in topical medicines for dermal application. 3977 POLYBUTENE E Only for use in topical medicines for dermal application. 3978 POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 3979 POLYCAPROLACTONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 3980 POLYDECENE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 6%. 3981 POLYDEXTROSE E 3982 POLYDIETHYLSILOXANE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 5%. 3983 POLYDIMETHYL SILOXANE E Permitted for use only in combination with other permitted ingredients as a printing ink. If used in a printing ink the total printing ink concentration in a medicine must be no more than 0.1% 3984 POLYESTER-10 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%. 3985 POLYESTER-25 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 10%. 3986 POLYESTER-7 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 3987 POLYESTER-8 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration of Polyester-8 must be no more than 5%. 3988 POLYETHYLENE E 3989 POLYGALA CHINENSIS A, H 3990 POLYGALA SENEGA A, E, H Except when used in a medicine containing only homoeopathic preparations, a child resistant closure and restricted flow insert must be fitted onto the container. 3991 POLYGALA SIBIRICA A, E, H Only for use when the plant part is root or root bark. 3992 POLYGALA TENUIFOLIA A Only for use when the plant part is root or root bark. 3993 POLYGLYCERYL-10 PENTASTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%. 3994 POLYGLYCERYL-2 CAPRATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin or in the eye. The concentration in the medicine must not be more than 0.5%. 3995 POLYGLYCERYL-2 DIISOSTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3.0%. 3996 POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%. 3997 POLYGLYCERYL-2 DISTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 3%. 3998 POLYGLYCERYL-2 ISOSTEARATE E Polyglyceryl-2 isostearate must: (a) Only be used in topical medicines for dermal application; and (b) Not be included in medicines intended for use on broken skin or in the eye. The concentration in the medicine must be no more than 2.5%. 3999 POLYGLYCERYL-2 TRIISOSTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. When the concentration of polyglyceryl-2 triisostearate is greater than 3%, the medicine must not be intended for use on damaged skin. The concentration in the medicine must not be more than 5%. 4000 POLYGLYCERYL-2-PEG-4 STEARATE E Only for use in topical medicines for dermal application. 4001 POLYGLYCERYL-3 BEESWAX E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.5%. 4002 POLYGLYCERYL-3 DIISOSTEARATE E Only for use in topical medicines for dermal application. 4003 POLYGLYCERYL-3 DISTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 4004 POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 6%. 4005 POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5.5%. 4006 POLYGLYCERYL-3 POLYRICINOLEATE E 4007 POLYGLYCERYL-3 STEARATE/ISOSTEARATE/DIMER DILINOLEATE CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 5%. 4008 POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. 4009 POLYGLYCERYL-4 ISOSTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 4010 POLYGLYCERYL-4 OLEATE E Only for use in topical medicines for dermal application. 4011 POLYGLYCERYL-6 POLYRICINOLEATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 4012 POLYGLYCERYL-6 RICINOLEATE E Only for use in topical medicines for dermal application. 4013 POLYGONATUM MULTIFLORUM A, H 4014 POLYGONATUM OFFICINALE A, H 4015 POLYGONATUM SIBIRICUM A, E, H 4016 POLYGONUM AVICULARE A, E, H When used as an excipient, the medicine is only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin or in the eye. When used as an excipient, the concentration in the medicine must be no more than 0.16%. 4017 POLYGONUM BISTORTA A, H 4018 POLYGONUM ODORATUM A, H 4019 POLYHYDROXYSTEARIC ACID E Only for use in topical medicines for dermal application. 4020 POLYISOBUTYLENE E Only for use when the dosage form is 'chewing gum'. Must comply with: a) the Polyisobutylene monograph in the Food Chemicals Codex published by the United States Pharmacopeial Convention, as in force or existing from time to time; and b) the requirements for residual solvents and catalysts in the British Pharmacopoeia or the United States Pharmacopeia National Formulary, as in force or existing from time to time. 4021 POLYISOPRENE E Only for use in topical medicines for dermal application. 4022 POLYLIMONENE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4023 POLYMETHACRYLIC ACID E 4024 POLYMETHYL METHACRYLATE E Methyl methacrylate is a mandatory component of polymethyl methacrylate. Only for use in topical medicines for dermal application. The total concentration of methyl methacrylate as residual monomer in the medicine must not be more than 1%. 4025 POLYMETHYLSILSESQUIOXANE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. 4026 POLYPORUS UMBELLATUS A, H 4027 POLYPROPYLENE E Only for use in topical medicines for dermal application. 4028 POLYPROPYLENE GLYCOL E Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 4029 POLYQUATERNIUM-10 E Only for use in topical medicines for dermal application. 4030 POLYQUATERNIUM-11 E Only for use in topical medicines for dermal application. 4031 POLYQUATERNIUM-22 E Only for use in wash-off topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. 4032 POLYQUATERNIUM-24 E Only for use in topical medicines for dermal application. 4033 POLYQUATERNIUM-28 E Only for use in topical medicines for dermal application. 4034 POLYQUATERNIUM-37 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2.5%. 4035 POLYQUATERNIUM-4 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 0.4%. 4036 POLYQUATERNIUM-44 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.3%. 4037 POLYQUATERNIUM-51 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 4038 POLYQUATERNIUM-7 E Only for use in topical medicines for dermal application. 4039 POLYSILICONE-11 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2.1% 4040 POLYSILICONE-14 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration of Polysilicone-14 must be no more than 1%. 4041 POLYSILICONE-15 A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 4042 POLYSILICONE-2 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.13%. 4043 POLYSORBATE 20 E 4044 POLYSORBATE 40 E 4045 POLYSORBATE 60 E 4046 POLYSORBATE 65 E 4047 POLYSORBATE 80 E 4048 POLYSORBATE 85 E Only for use in topical medicines for dermal application. 4049 POLYSTYRENE E Only for use as part of an adhesive in topical medicines for dermal application. 4050 POLYTEF E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 4051 POLYURETHANE-34 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2% in spray applications and 6% in non-spray applications. 4052 POLYURETHANE-62 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 5%. 4053 POLYVINYL ACETATE E Only permitted for use in medicines that are for oral routes of administration. 4054 POLYVINYL ACETATE PHTHALATE E 4055 POLYVINYL ALCOHOL E 4056 POLYVINYL CHLORIDE E Only for use in topical medicines for dermal application. 4057 POMEGRANATE E 4058 PONCEAU SX E Permitted for use only as a colour for topical use. 4059 PONCIRUS TRIFOLIATA A, H When used internally, oxedrine is a mandatory component of Poncirus trifoliata. The quantity of Oxedrine in the maximum recommended daily dose must be no more than 30 mg. 4060 PONGAMOL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 4061 PONTEDERIA CRASSIPES A, H 4062 POPPY SEED E, H 4063 POPPY SEED OIL E, H 4064 POPULUS ALBA A, H 4065 POPULUS BALSAMIIFERA A, E, H 4066 POPULUS CANDICANS A, H 4067 POPULUS DELTOIDES A, H 4068 POPULUS NIGRA A, H 4069 POPULUS TREMULA A, H 4070 POPULUS TREMULOIDES A, H 4071 PORCINE H Only for use as an active homoeopathic ingredient. 4072 PORPHYRIDIUM PURPUREUM EXTRACT E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 4073 PORTULACA OLERACEA A, E, H 4074 POTABLE WATER E 4075 POTASSIUM ACETATE E 4076 POTASSIUM ARSENITE H Only for use as an active homoeopathic ingredient. 4077 POTASSIUM ASCORBATE A, E, H When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate. 4078 POTASSIUM ASCORBATE DIHYDRATE A, E, H When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate dihydrate. 4079 POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE E Only for use in topical medicines for dermal application. 4080 POTASSIUM ASPARTATE A, E, H When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium aspartate. 4081 POTASSIUM ASPARTATE DIHYDRATE A, E, H If used as an active ingredient and the preparation is intended as a mineral supplementation, potassium is a mandatory component of Potassium aspartate dihydrate. The percentage of potassium from potassium aspartate dihydrate should be calculated based on the molecular weight of potassium aspartate dihydrate. 4082 POTASSIUM ASPARTATE MONOHYDRATE A, E If used as an active ingredient and the preparation is intended as a mineral supplementation, potassium is a mandatory component of Potassium aspartate monohydrate. The percentage of potassium from potassium aspartate monohydrate should be calculated based on the molecular weight of potassium aspartate monohydrate. 4083 POTASSIUM BICARBONATE E 4084 POTASSIUM BROMIDE H Only for use as an active homoeopathic ingredient. The total concentration of potassium bromide in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 4085 POTASSIUM CARBONATE E, H When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 4086 POTASSIUM CETYL PHOSPHATE E Only for use in topical medicines for dermal application. 4087 POTASSIUM CHLORIDE A, E, H When for oral use: (a) potassium is a mandatory component of potassium chloride; (b) the medicine requires the following warning statement on the medicine label: - (POTAS1) 'If you have kidney disease or are taking heart or blood pressure medicines - consult your doctor or pharmacist before use. Keep out of reach of children.'; and (c) except when the medicine is for use as oral rehydration therapy, the amount of potassium chloride per dosage unit must not be more than 550 mg. Medicines containing potassium chloride for use as oral rehydration therapy, are subject to the following conditions: (a) the medicine complies with the requirements specified in the British Pharmacopoeia, as in force or existing from time to time, for Oral Rehydration Salts; (b) the sodium, potassium and glucose content, and total osmolarity of the solution after it has been prepared according to the instructions on the packet are consistent with the criteria specified by the World Health Organisation (WHO) and the United Nations Children's Fund (UNICEF) in the document 'Expert consultation on oral rehydration salts formulation' 18 July 2001; and (c) the following warning statements are required on the medicine label: - (UOAD) 'Use only as directed' - (DIAR3) 'If diarrhoea persists, seek medical advice.' When for dental use, the concentration of potassium chloride in the medicine must not be more than 3.75%. 4088 POTASSIUM CITRATE A, E, H When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium citrate. 4089 POTASSIUM COCOYL HYDROLYSED COLLAGEN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. 4090 POTASSIUM COCOYL HYDROLYSED SOY PROTEIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.15%. 4091 POTASSIUM DICHROMATE H Only for use as an active homoeopathic ingredient. 4092 POTASSIUM GLUCONATE A, E, H When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium gluconate. 4093 POTASSIUM GLYCEROPHOSPHATE A, E, H When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium glycerophosphate. 4094 POTASSIUM HYDROXIDE E The concentration in the medicine must be no more than 5%. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 4095 POTASSIUM HYDROXYCITRATE A, H The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. When for oral use, the following warning statement is required on the medicine label: 'In very rare cases, potassium hydroxycitrate may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.' Medicines containing potassium hydroxycitrate must not be directed for use in children, or in pregnant or lactating women. 4096 POTASSIUM IODATE A, H Iodine is a mandatory component of potassium iodate. The percentage of iodine from potassium iodate should be calculated based on the molecular weight of potassium iodate. When for use in adults, the medicine must contain a daily dose of no more than 505 micrograms of potassium iodate. When for use in children aged 1-3 years, the medicine must contain a daily dose of no more than 337 micrograms of potassium iodate. 4097 POTASSIUM IODIDE A, E, H Iodine is a mandatory component of potassium iodide. The percentage of iodine from potassium iodide should be calculated based on the molecular weight of potassium iodide. When for internal use, the maximum recommended daily dose of the medicine must contain less than 300 micrograms of iodine. When for external use, the concentration of iodine in the medicine (excluding salt derivatives or iodophors) must not exceed 2.5%. 4098 POTASSIUM METABISULFITE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4099 POTASSIUM METAPHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 4100 POTASSIUM NITRATE A, H Only for dental use. The concentration in the medicine must be no more than 5%. 4101 POTASSIUM OROTATE A, E, H When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium orotate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 4102 POTASSIUM PYROPHOSPHATE E Only for oral application, dental or topical use. Not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. 4103 POTASSIUM SORBATE E 4104 POTASSIUM STANNATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4105 POTASSIUM STEARATE E Only for use in topical medicines for dermal application. 4106 POTASSIUM SULFATE A, E, H When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium sulfate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 4107 POTATO STARCH E 4108 POTENTILLA ANSERINA A, H 4109 POTENTILLA CHINENSIS A, H 4110 POTENTILLA DISCOLOR A, H 4111 POTENTILLA ERECTA A, E, H 4112 POTENTILLA REPTANS A, H 4113 POTERIUM OFFICINALE A, E, H 4114 POTERIUM SANGUISORBA A, H 4115 POVIDONE E 4116 POWDERED CELLULOSE E 4117 PPG-1-PEG-9 LAURYL GLYCOL ETHER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 4118 PPG-12/SMDI COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 4119 PPG-15 STEARYL ETHER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. 4120 PPG-15 STEARYL ETHER BENZOATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.4%. 4121 PPG-17/IPDI/DMPA COPOLYMER E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration of PPG-17/IPDI/DMPA Copolymer in the medicine must be no more than 10%. 4122 PPG-2 LANOLIN ALCOHOL ETHER E Only for use in topical medicines for dermal application. 4123 PPG-2 MYRISTYL ETHER PROPIONATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 4124 PPG-20 LANOLIN ALCOHOL ETHER E Only for use in topical medicines for dermal application. 4125 PPG-20 METHYL GLUCOSE ETHER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 4126 PPG-20 METHYL GLUCOSE ETHER DISTEARATE E Only for use in topical medicines for dermal application. 4127 PPG-3 HYDROGENATED CASTOR OIL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 6%. 4128 PPG-3 MYRISTYL ETHER E Only for use in topical medicines for dermal application. 4129 PPG-5-CETETH-20 E Only for use in topical medicines for dermal application. 4130 PPG-5-LAUROMACROGOL 250 E Only for use in topical medicines for dermal application. 4131 PRALINE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4132 PREGELATINISED MAIZE STARCH E 4133 PREGELATINISED POTATO STARCH E 4134 PREGELATINISED RICE STARCH E 4135 PREGELATINISED STARCH E 4136 PREGELATINISED WHEAT STARCH E When the route of administration is other than topical or mucosal, gluten is a mandatory component of pregelatinised wheat starch. 4137 PRENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4138 PRICKLY ASH BARK DRY A, H 4139 PRICKLY ASH BARK POWDER A, H 4140 PRIMULA VERIS A, E, H 4141 PRIMULA VULGARIS A, E, H 4142 PRINSEPIA UNIFLORA A, H 4143 PROBOSCIDEA PARVIFLORA A, H 4144 PROGESTERONE H Only for use as an active homoeopathic ingredient. The total concentration of progesterone in the medicine must not be more than 1 mg/kg or 1 mg/L or 0.0001%. 4145 PROLINE A, E 4146 PROPAN-1-OL E Only for use in: - topical medicines for dermal application; or - in combination with other permitted ingredients as a flavour proprietary excipient formulation. The concentration of propan-1-ol in the medicine must not be more than 18%. When used in medicines in combination with other permitted ingredients as a flavour proprietary excipient formulation, the total flavour proprietary excipient formulation in a medicine must not be more than 5%. 4147 PROPANE E Only for use as an excipient propellant ingredient. 4148 PROPANEDIOL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 10%. 4149 PROPENYL GUAETHOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4150 PROPIONALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4151 PROPIONIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4152 PROPIONYLLEVOCARNITINE HYDROCHLORIDE A, H 4153 PROPOLIS A, E Lead is a mandatory component of Propolis. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.' 4154 PROPOLIS BALSAM A, E Lead is a mandatory component of Propolis balsam. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.' 4155 PROPOLIS DRY EXTRACT A, E Lead is a mandatory component of Propolis dry extract. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.' 4156 PROPOLIS LIQUID EXTRACT A, E Lead is a mandatory component of Propolis liquid extract. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.' 4157 PROPOLIS RESIN A, E Lead is a mandatory component of propolis resin. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.' 4158 PROPOLIS TINCTURE A, E Lead is a mandatory component of Propolis tincture. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.' 4159 PROPYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4160 PROPYL CAPROATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4161 PROPYL GALLATE E 4162 PROPYL HYDROXYBENZOATE E 4163 PROPYLENE CARBONATE E Only for use in topical medicines for dermal application. 4164 PROPYLENE GLYCOL E 4165 PROPYLENE GLYCOL ALGINATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4166 PROPYLENE GLYCOL DIBENZOATE E Only for use in topical medicines for dermal application only and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 20%. 4167 PROPYLENE GLYCOL DIDECANOATE E Only for use in topical medicines for dermal application only and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 4168 PROPYLENE GLYCOL DIOCTANOATE E Only for use in topical medicines for dermal application. 4169 PROPYLENE GLYCOL DIOCTANOATE/DIDECANOATE E Only for use in topical medicines for dermal application. 4170 PROPYLENE GLYCOL DIPELARGONATE E Only for use in topical medicines for dermal application. 4171 PROPYLENE GLYCOL ISOCETETH-3 ACETATE E Only for use in topical medicines for dermal application only and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 4172 PROPYLENE GLYCOL ISOSTEARATE E Only for use in topical medicines for dermal application. 4173 PROPYLENE GLYCOL MONOLAURATE E Only for use in topical medicines for dermal application. 4174 PROPYLENE GLYCOL MONOSTEARATE E Only for use in topical medicines for dermal application. 4175 PROPYLENE GLYCOL MYRISTYL ETHER ACETATE E Only for use in topical medicines for dermal application. 4176 PROSOPIS JULIFLORA A, H 4177 PROTEASE A Must be derived from Aspergillus oryzae or Aspergillus niger. 4178 PROTEIN HYDROLYSATE E 4179 PRUNE JUICE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4180 PRUNE JUICE CONCENTRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4181 PRUNELLA VULGARIS A, H 4182 PRUNUS AFRICANA A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus africana. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4183 PRUNUS ARMENIACA A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus armeniaca and must be declared in the application. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4184 PRUNUS AVIUM A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus avium. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4185 PRUNUS CERASIFERA A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus cerasifera. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4186 PRUNUS CERASUS A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus cerasus. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4187 PRUNUS DOMESTICA A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus domestica. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4188 PRUNUS DULCIS A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus dulcis when the plant part is seed. When the plant part is seed, the maximum recommended daily dose must be no more than the equivalent of 1mg of the dry seed. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4189 PRUNUS HUMILIS A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus humilis. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4190 PRUNUS JAPONICA A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus japonica. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4191 PRUNUS LAUROCERASUS A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus laurocerasus. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4192 PRUNUS MUME A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus mume. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4193 PRUNUS PERSICA A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus persica. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4194 PRUNUS SALICINA A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus salicina. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4195 PRUNUS SEROTINA A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus serotina. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4196 PRUNUS SPINOSA A, E, H Amygdalin and hydrocyanic acid are mandatory components of Prunus spinosa. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. 4197 PRUSSIAN BLUE E Permitted for use only as a colour for topical use. 4198 PSEUDOCYDONIA SINENSIS A, H 4199 PSEUDOSTELLARIA HETEROPHYLLA A, E, H 4200 PSEUDOTSUGA MENZIESII A, H 4201 PSEUDOWINTERA COLORATA A, H Only for use when the plant part is leaf. 4202 PSIDIUM GUAJAVA A, E, H 4203 PSORINUM H Only for use as an active homoeopathic ingredient. 4204 PSYLLIUM HUSK DRY A, H When a dose for children is stated, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect). 4205 PSYLLIUM HUSK POWDER A, E, H When a dose for children is stated, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect). 4206 PSYLLIUM SEED DRY A, E, H When a dose for children is stated the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect). 4207 PTELEA TRIFOLIATA A, H 4208 PTEROCARPUS MARSUPIUM A, H 4209 PTEROCARPUS SANTALINUS A, E, H 4210 PUERARIA LOBATA A, E, H 4211 PUERARIA MONTANA VAR. LOBATA A, E, H 4212 PULLULAN E 4213 PUMICE E 4214 PUMPKIN E 4215 PUMPKIN SEED OIL E, H 4216 PUNICA GRANATUM A, E, H 4217 PURE BEE VENOM H Only for use as an active homoeopathic ingredient. 4218 PURIFIED HONEY A, E When the route of administration is oral, the following warning statement is required on the medicine label: - (BABY2) 'Not suitable for infants under the age of twelve months' (or words to that effect). 4219 PURIFIED SILICEOUS EARTH E, H 4220 PURIFIED TALC E 4221 PURIFIED WATER E 4222 PVM/MA COPOLYMER E 4223 PVM/MA DECADIENE CROSSPOLYMER E Only for use in topical medicines for dermal application. 4224 PVP/EICOSENE COPOLYMER E Only for use in topical medicines for dermal application. 4225 PVP/HEXADECENE COPOLYMER E Only for use in topical medicines for dermal application. 4226 PYRETHRINS E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 10%. The medicine requires the following warning statement on the medicine label: - (PYRTH3) 'Contains pyrethrins [insert quantity]' (or words to that effect). 4227 PYRIDOXAL 5-PHOSPHATE A, E Pyridoxine is a mandatory component of pyridoxal 5-phosphate. The percentage of pyridoxine from pyridoxal 5-phosphate should be calculated based on the molecular weight of pyridoxal 5-phosphate. The maximum recommended daily dose of the medicine must not provide more than: (i) 15 mg of pyridoxine for children aged between 1 and 3 years (inclusive); (ii) 20 mg of pyridoxine for children aged between 4 and 8 years (inclusive); (iii) 30 mg of pyridoxine for children aged between 9 and 13 years (inclusive); (iv) 40 mg of pyridoxine for individuals aged 14 and 18 years (inclusive); and (v) 100 mg of pyridoxine for individuals aged 19 years and older. If the maximum recommended daily dose of the medicine provides more than 10 mg of pyridoxine, the following warning statement is required on the medicine label: - (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6]. 4228 PYRIDOXAL 5-PHOSPHATE MONOHYDRATE A Pyridoxine is a mandatory component of pyridoxal 5-phosphate monohydrate. The percentage of pyridoxine from pyridoxal 5-phosphate monohydrate should be calculated based on the molecular weight of pyridoxal 5-phosphate monohydrate. The maximum recommended daily dose of the medicine must not provide more than: (i) 15 mg of pyridoxine for children aged between 1 and 3 years (inclusive); (ii) 20 mg of pyridoxine for children aged between 4 and 8 years (inclusive); (iii) 30 mg of pyridoxine for children aged between 9 and 13 years (inclusive); (iv) 40 mg of pyridoxine for individuals aged 14 and 18 years (inclusive); and (v) 100 mg of pyridoxine for individuals aged 19 years and older. If the maximum recommended daily dose of the medicine provides more than 10 mg of pyridoxine, the following warning statement is required on the medicine label: - (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].' 4229 PYRIDOXINE HYDROCHLORIDE A, E, H When not used as an active homoeopathic ingredient, pyridoxine is a mandatory component of pyridoxine hydrochloride. The percentage of pyridoxine from pyridoxine hydrochloride should be calculated based on the molecular weight of pyridoxine hydrochloride. The maximum recommended daily dose of the medicine must not provide more than: (i) 15 mg of pyridoxine for children aged between 1 and 3 years (inclusive); (ii) 20 mg of pyridoxine for children aged between 4 and 8 years (inclusive); (iii) 30 mg of pyridoxine for children aged between 9 and 13 years (inclusive); (iv) 40 mg of pyridoxine for individuals aged 14 and 18 years (inclusive); and (v) 100 mg of pyridoxine for individuals aged 19 years and older. If the maximum recommended daily dose of the medicine provides more than 10 mg of pyridoxine, the following warning statement is required on the medicine label: - (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].' 4230 PYROGLUTAMIC ACID E 4231 PYROLA DECORATA A, H 4232 PYROLIGNEOUS ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4233 PYRROSIA LINGUA A, H 4234 PYRROSIA PETIOLOSA A, H 4235 PYRROSIA SHEARERI A, H 4236 PYRUS COMMUNIS A, E, H Beta-arbutin is a mandatory component of Pyrus communis. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 4237 PYRUS PYRIFOLIA A, H Beta-arbutin is a mandatory component of Pyrus pyrifolia. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 4238 PYRUVIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4239 QUASSIA E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4240 QUASSIA AMARA A, E, H 4241 QUASSIA WOOD JAMAICAN DRY A, H 4242 QUASSIA WOOD JAMAICAN POWDER A, H 4243 QUATERNIUM-15 E Only for use in topical medicines for dermal application. 4244 QUATERNIUM-18 BENTONITE E Only for use in topical medicines for dermal application. 4245 QUATERNIUM-18 HECTORITE E Only for use in topical medicines for dermal application. 4246 QUATERNIUM-52 E Only for use in wash-on/wash-off topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. Not be used in medicines in which N-nitroso compounds may be formed. 4247 QUATERNIUM-80 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2.5%. 4248 QUERCETIN A 4249 QUERCETIN DIHYDRATE A 4250 QUERCUS ACUTISSIMA A, H 4251 QUERCUS ALBA A, E, H 4252 QUERCUS PALUSTRIS A, H 4253 QUERCUS ROBUR A, H 4254 QUERCUS RUBRA A, H 4255 QUERCUS VIRGINIANA A, H 4256 QUILLAIA DRY A, H 4257 QUILLAIA POWDER A, E, H 4258 QUILLAJA SAPONARIA A, H 4259 QUINCE E 4260 QUININE ARSENITE H Only for use as an active homoeopathic ingredient. Quinine is a mandatory component of Quinine arsenite. The maximum recommended daily dose must be no more than 50 mg of quinine. 4261 QUININE SULFATE DIHYDRATE H Only for use as an active homoeopathic ingredient. Quinine is a mandatory component of quinine sulfate dihydrate. The maximum recommended daily dose must be no more than 50 mg of quinine. 4262 QUINOLINE YELLOW E Permitted for use only as a colour for oral and topical use. 4263 QUINOLINE YELLOW ALUMINIUM LAKE E Permitted for use only as a colour for oral and topical use. 4264 QUISQUALIS INDICA A, H 4265 R-ALPHA LIPOIC ACID A 4266 RACEMENTHOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4267 RACEMIC CAMPHOR E, H Only for use as an active homoeopathic or excipient ingredient. In solid and semi solid preparations, the concentration of camphor must not be more than 12.5%. In liquid preparations other than essential oils, the concentration of camphor must not be more than 2.5%. In essential oil preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect). In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect). In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) 'Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist' (or words to that effect). If the concentration of camphor is more than 2.5%, the nominal capacity of the container must not be more than 25 millilitres. 4268 RAISIN JUICE CONCENTRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4269 RANUNCULUS BULBOSUS A, H 4270 RANUNCULUS FICARIA A, H 4271 RANUNCULUS TERNATUS A, H 4272 RAPE SEED OIL A, E, H Allyl isothiocyanate is a mandatory component of rape seed oil when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 4273 RAPHANUS SATIVUS A, E, H When used as an excipient, the plant preparation must be limited to fresh, dry, powder, oil, fresh juice, dry juice, or concentrated juice. 4274 RASPBERRY E 4275 RASPBERRY BRANDY E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4276 RASPBERRY DISTILLATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4277 RASPBERRY FRUIT EXTRACT E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4278 RASPBERRY JUICE CONCENTRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4279 RAUWOLFIA SERPENTINA A, H The concentration of equivalent dry Rauwolfia serpentina in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%. 4280 RAUWOLFIA SERPENTINA DRY A, H The concentration of Rauwolfia Serpentina Dry in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%. 4281 RAUWOLFIA SERPENTINA POWDER A, H The concentration of Rauwolfia Serpentina Powder in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%. 4282 RED 27 E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. The concentration in the medicine must be no more than 0.5%. 4283 RED 27 ALUMINIUM LAKE E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. The concentration in the medicine must be no more than 0.5%. 4284 RED ANT H Only for use as an active homoeopathic ingredient. 4285 RED CLOVER FLOWER DRY A, H 4286 RED CLOVER FLOWER POWDER A, H 4287 RED CORAL H Only for use as an active homoeopathic ingredient. 4288 RED DEER A 4289 RED MERCURIC IODIDE H Only for use as an active homoeopathic ingredient. 4290 RED MERCURIC OXIDE H Only for use as an active homoeopathic ingredient. 4291 RED MERCURIC SULFIDE H Only for use as an active homoeopathic ingredient. 4292 REFINED BUGLOSSOIDES ARVENSIS SEED OIL A Only to be used in a medicine where Phytolove Pty Ltd (Client ID 80651), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 3 July 2025. Stearidonic acid is a mandatory component of refined Buglossoides arvensis seed oil. The route of administration for medicines that contain refined Buglossoides arvensis seed oil must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 500 mg of stearidonic acid. The following warning statement (or words to that effect) is required on the medicine label: - (NTAKEN3) 'Not to be taken by children under 3 years old'. 4293 REHMANNIA GLUTINOSA A, E, H 4294 REL-1-((1R,2S)-1,2,3,4,5,6,7,8-OCTAHYDRO-1,2,8,8-TETRAMETHYL-2-NAPHTHALENYL)-1-ETHANONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4295 RESORCINOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4296 RESORCINOL DIMETHYLETHER E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4297 RESVERATROL A Only permitted for use in medicines that are for oral routes of administration. The maximum recommended daily dose of the medicine must not contain more than 150 milligrams of resveratrol. The following warning statements are required on the medicine label: - (RESVER) 'Resveratrol may affect the way some medicines work, including Warfarin. Consult your health professional before taking with other medicines (or words to that effect).'; - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect)'; and - (CHILD2) 'Not suitable for children'. 4298 RETINOL A, E Vitamin A is a mandatory component of retinol. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) 'WARNING: If you are pregnant - or considering becoming pregnant - do not take Vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].' NOTE: Position this warning at the beginning of the directions for use. - (VITA4) 'WARNING - When taken in excess of 3000 micrograms retinol equivalents - Vitamin A can cause birth defects.' NOTE: Position this warning at the beginning of the directions for use. - (VITA3) 'The recommended daily amount of Vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.' 4299 RETINOL ACETATE A, E Vitamin A is a mandatory component of retinol acetate. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) 'WARNING: If you are pregnant - or considering becoming pregnant - do not take Vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].' NOTE: Position this warning at the beginning of the directions for use. - (VITA4) 'WARNING - When taken in excess of 3000 micrograms retinol equivalents - Vitamin A can cause birth defects.' NOTE: Position this warning at the beginning of the directions for use. - (VITA3) 'The recommended daily amount of Vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.' 4300 RETINOL PALMITATE A, E Vitamin A is a mandatory component of retinol palmitate. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) 'WARNING: If you are pregnant - or considering becoming pregnant - do not take Vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].' NOTE: Position this warning at the beginning of the directions for use. - (VITA4) 'WARNING - When taken in excess of 3000 micrograms retinol equivalents - Vitamin A can cause birth defects.' NOTE: Position this warning at the beginning of the directions for use. - (VITA3) 'The recommended daily amount of Vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.' 4301 REYNOUTRIA JAPONICA A, E, H When used as an excipient, only for use in topical medicines for dermal application. 4302 RHAMNOSE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4303 RHAMNUS CATHARTICA A, H When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rhamnus cathartica. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4304 RHAMNUS FRANGULA A, H Glucofrangulins calculated as glucofrangulin A is a mandatory component of Rhamnus frangula. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4305 RHATANY ROOT DRY A, H 4306 RHATANY ROOT POWDER A, H 4307 RHEUM OFFICINALE A, E, H The plant part must not be leaf. When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum officinale. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4308 RHEUM PALMATUM A, E, H The plant part must not be leaf. When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum palmatum. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4309 RHEUM RHAPONTICUM A, E, H The plant part must not be leaf. When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rheum rhaponticum. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4310 RHEUM TANGUTICUM A, H The plant part must not be leaf. When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum tanguticum. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4311 RHODAMINE B E Permitted for use only as a colour for topical use. 4312 RHODINOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4313 RHODINYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. 4314 RHODIOLA ROSEA A Only for use in oral medicines. Only available for use when the plant preparation is dry root powder, dry root powder as an aqueous extract or dry root powder as a hydroethanolic extract with no more than 70% ethanol v/v. 4315 RHODODENDRON AUREUM A, H 4316 RHODODENDRON FERRUGINEUM A, H Beta-arbutin is a mandatory component of Rhododendron ferrugineum. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 4317 RHODODENDRON GROENLANDICUM A, H 4318 RHODODENDRON MOLLE A, H The maximum recommended daily dose of the medicine must be no more than 1mg of the dry herbal material. 4319 RHUBARB E, H When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rhubarb. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4320 RHUBARB ROOT DRY A, H When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of rhubarb root dry. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4321 RHUBARB ROOT POWDER A, H When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of rhubarb root powder. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4322 RHUS AROMATICA A, E, H 4323 RHUS CHINENSIS A, H 4324 RHUS GLABRA A, E, H 4325 RHUS VENENATA H Only for use as an active homoeopathic ingredient. 4326 RIBES GROSSULARIA A, E, H 4327 RIBES NIGRUM A, E, H 4328 RIBOFLAVIN A, E 4329 RIBOFLAVIN SODIUM PHOSPHATE A, E 4330 RIBOFLAVIN TETRAACETATE E Only for use in topical medicines for dermal application. 4331 RIBOFLAVINE A, E 4332 RIBOFLAVINE SODIUM PHOSPHATE A, E 4333 RIBONUCLEIC ACID E Only for use in topical medicines for dermal application. 4334 RIBOSE A Only for use in oral medicines. 4335 RICE E 4336 RICE BRAN E 4337 RICE BRAN OIL E 4338 RICE BRAN WAX A, E, H 4339 RICE STARCH E 4340 RICE VINEGAR E 4341 RICE WINE E Ethanol is a mandatory component of rice wine. 4342 RICINOLEIC ACID E Only for use in topical medicines for dermal application. 4343 RICINUS COMMUNIS A, H Only for use when the plant part must be seed and the plant preparation is oil fixed. 4344 ROBINIA PSEUDOACACIA A, E, H When the herbal substance is derived from plant parts other than the leaf or flower, the maximum recommended daily dose of the medicine must be no more than 1mg of the dry herbal material. 4345 ROHDEA JAPONICA A, H The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material. 4346 ROSA ARVENSIS A, E, H 4347 ROSA CANINA A, E, H 4348 ROSA CYMOSA A, E, H 4349 ROSA EGLANTERIA A, E, H 4350 ROSA GALLICA A, E, H 4351 ROSA LAEVIGATA A, E, H 4352 ROSA MULTIFLORA A, E, H 4353 ROSA ROXBURGHII FRUIT EXTRACT E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.002%. 4354 ROSA RUGOSA A, E, H 4355 ROSA VILLOSA A, E, H 4356 ROSA X CENTIFOLIA A, E, H 4357 ROSA X DAMASCENA A, E, H 4358 ROSANA E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4359 ROSE ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4360 ROSE FRUIT FRESH A, E, H 4361 ROSE HIP E 4362 ROSE OIL A, E, H 4363 ROSE OXIDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4364 ROSEMARY OIL A, E, H Safrole is a mandatory component of Rosemary oil. When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%. 4365 ROSMARINUS OFFICINALIS A, E, H Camphor and cineole are mandatory components of Rosmarinus officinalis except when the plant preparation is an essential oil or distillate. In solid and semi-solid preparations, the concentration of camphor must not be more than 12.5%. In liquid preparations other than essential oils or distillates, the concentration of camphor must not be more than 2.5%. When the concentration of cineole in the preparation other than essential oils or distillates is more than 25%, the nominal capacity of the container must not be more than 25 millilitres. In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. 4366 ROYAL JELLY A, E 10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly. The medicine requires the following warning statements on the medicine label: - (CHILD2) 'Not suitable for children' - (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'. 4367 ROYAL JELLY FRESH A, E 10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly fresh. The medicine requires the following warning statements on the medicine label: - (CHILD2) 'Not suitable for children' - (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'. 4368 ROYAL JELLY LYOPHILISED A, E 10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly lyophilised. The medicine requires the following warning statements on the medicine label: - (CHILD2) 'Not suitable for children' - (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'. 4369 RUBBER NATURAL E Only for use in topical medicines for dermal application. 4370 RUBIA CORDIFOLIA A, H 4371 RUBIA TINCTORUM A, H 4372 RUBUS CHINGII A, H 4373 RUBUS CORCHORIFOLIUS A, H 4374 RUBUS COREANUS A, E, H 4375 RUBUS FRUTICOSUS A, E, H 4376 RUBUS IDAEUS A, E, H 4377 RUBUS OCCIDENTALIS A, E, H 4378 RUBUS PARVIFOLIUS A, H 4379 RUBUS ROSIFOLIUS A, H 4380 RUDBECKIA HIRTA A, H 4381 RUE OIL A, E, H The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. When used as an active ingredient: (a) Rue oil must only be used as a homoeopathic ingredient; (b) the routes of administration for medicines that contain rue oil must be limited to: (i) topical for dermal use; and (ii) oral; (c) when the homoeopathic potency of the medicine containing rue oil is 12X or lower, the following warning statement is required on the medicine label: - (NEW) 'Do not use if pregnant or likely to become pregnant, or during lactation.'; and (d) when the medicine is for dermal use, the following statement is required on the medicine: - (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect). When used as an excipient ingredient: (a) The route of administration for medicines that contain rue oil must be limited to topical; (b) rue oil must only be included in combination with other permitted ingredients as a fragrance proprietary excipient formulation; (c) the total concentration of fragrance proprietary excipient formulations containing rue oil must not be more than 1% of the total medicine; and (d) the total concentration of rue oil in the medicine must not be more than 0.15%. 4382 RUM E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4383 RUMEX ACETOSA A, H 4384 RUMEX ACETOSELLA A, H 4385 RUMEX CONGLOMERATUS A, H 4386 RUMEX CRISPUS A, E, H 4387 RUMEX PULCHER A, H 4388 RUMEX SCUTATUS A, H 4389 RUSCUS ACULEATUS A, H 4390 RUTA GRAVEOLENS A, E, H The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. When used as an active ingredient: (a) Ruta graveolens must only be used as a homoeopathic ingredient; (b) the routes of administration for medicines that contain Ruta graveolens must be limited to: (i) topical for dermal use; and (ii) oral; (c) when the homoeopathic potency of the medicine containing Ruta graveolens is 12X or lower, the following warning statement is required on the medicine label: - (NEW) 'Do not use if pregnant or likely to become pregnant, or during lactation.'; and (d) when the medicine is for dermal use, the following statement is required on the medicine: - (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect). When used as an excipient ingredient: (a) The route of administration for medicines that contain Ruta graveolens must be limited to topical; (b) Ruta graveolens must only be included in combination with other permitted ingredients as a fragrance proprietary excipient formulation; (c) the total concentration of fragrance proprietary excipient formulations containing Ruta graveolens must not be more than 1% of the total medicine; and (d) the total concentration of Ruta graveolens in the medicine must not be more than 0.15%. 4391 RUTOSIDE A, E 4392 RUTOSIDE TRIHYDRATE A, E 4393 RYE E Gluten is a mandatory component of Rye when the route of administration is other than topical and mucosal. 4394 RYE BRAN E Gluten is a mandatory component of Rye bran when the route of administration is other than topical and mucosal. 4395 S-ISOPROPYL 3-METHYLTHIOCROTONATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4396 SABINENE E Sabinene must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing sabinene must not be more than 5% of the total medicine. 4397 SABINENE HYDRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4398 SACCHARIDE ISOMERATE E Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 3.66%. 4399 SACCHARIN E 4400 SACCHARIN SODIUM E 4401 SACCHAROMYCES CEREVISIAE A, E When for topical use, the concentration in the medicine must be no more than 1%. 4402 SACCHAROMYCES CEREVISIAE (BOULARDII) A 4403 SACCHAROMYCES CEREVISIAE POLYSACCHARIDES E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 4404 SACCHAROMYCES/ZINC FERMENT E Only for use in topical medicines for dermal application. 4405 SACCHARUM OFFICINARUM A, E, H 4406 SAFFLOWER OIL A, E, H 4407 SAFFRON E Permitted for use only as a colour for either topical use or with an oral route of administration. 4408 SAGE LEAF DRY A, E, H Thujone is a mandatory component of Sage leaf dry. The concentration of thujone in the medicine must be no more than 4%. 4409 SAGE LEAF POWDER A, H Thujone is a mandatory component of Sage leaf powder. The concentration of thujone in the medicine must be no more than 4%. 4410 SAGE OIL DALMATIAN A Thujone is a mandatory component of Sage oil dalmatian. The concentration of thujone in the medicine must be no more than 4%. When the concentration of Sage oil dalmatian in the medicine is more than 10% and the nominal capacity of the container is no more than 15 mL, a restricted flow insert and child resistant closure must be fitted on the container and the medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect) - (NTAKEN) 'Not to be taken' 4411 SAGE OIL SPANISH A, E, H 4412 SALICORNIA EUROPAEA EXTRACT E Only for use in topical medicines for dermal use and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.002%. 4413 SALICYLALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4414 SALICYLIC ACID E, H Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 40%. 4415 SALIX ALBA A, E, H 4416 SALIX DAPHNOIDES A, H 4417 SALIX DISCOLOR A, H 4418 SALIX FRAGILIS A, H 4419 SALIX NIGRA A, H 4420 SALIX PURPUREA A, H 4421 SALSOLA KALI A, H 4422 SALVIA CHINENSIS A, H 4423 SALVIA FRUTICOSA A, H 4424 SALVIA HISPANICA A, E, H 4425 SALVIA LAVANDULAEFOLIA A, H 4426 SALVIA MILTIORRHIZA A, H 4427 SALVIA OFFICINALIS A, E, H Thujone is a mandatory component of Salvia officinalis. The concentration of thujone in the medicine must be no more than 4%. 4428 SALVIA SCLAREA A, E, H 4429 SAMBUCUS CANADENSIS A, H 4430 SAMBUCUS EBULUS A, H 4431 SAMBUCUS NIGRA A, E, H 4432 SANDALWOOD OIL EAST INDIAN A, E, H 4433 SANGUINARIA CANADENSIS H Only for use as an active homoeopathic ingredient. The potency must be more than 4X. 4434 SANICULA EUROPAEA A, H 4435 SANTALUM ALBUM A, E, H 4436 SANTALUM SPICATUM A, E, H The route of administration must be topical or inhalation. The plant preparation must be oil. The plant part must be root or stem wood including heartwood. 4437 SAPINDUS MUKOROSSI A, H 4438 SAPONARIA OFFICINALIS A, H 4439 SAPOSHNIKOVIA DIVARICATA A, H 4440 SARCOSINE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 4441 SARGASSUM FUSIFORME A, H Iodine is a mandatory component of Sargassum fusiforme. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 4442 SARGASSUM SILIQUASTRUM A, H Iodine is a mandatory component of Sargassum siliquastrum. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. 4443 SASSAFRAS ALBIDUM A, H Safrole is a mandatory component of Sassafras albidum. When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%. 4444 SATUREIA HORTENSIS A, H 4445 SATUREIA MONTANA A, H 4446 SAUROPUS SPATULIFOLIUS A, H 4447 SAURURUS CHINENSIS A, H 4448 SAUSSUREA COSTUS A, H 4449 SAVORY OIL SUMMER A, H 4450 SAXIFRAGA GRANULATA A, E, H 4451 SAXIFRAGA STOLONIFERA E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 0.0816%. 4452 SCAPHIUM SCAPHIGERUM A, H 4453 SCHEFFLERA HEPTAPHYLLA A, H 4454 SCHINOPSIS QUEBRACHO-COLORADO A, H 4455 SCHINUS MOLLE A, H 4456 SCHINUS MOLLE OIL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4457 SCHISANDRA CHINENSIS A, E, H 4458 SCHIZONEPETA TENUIFOLIA A, E, H 4459 SCHOENOCAULON OFFICINALE A, H The maximum recommended daily dose of the medicine must not contain more than the equivalent of 1 mg of the dry herbal material. The concentration of total alkaloids of Schoenocaulon officinale in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 4460 SCLAREOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4461 SCLAREOLIDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4462 SCLERANTHUS ANNUUS A, H 4463 SCLEROTIUM GUM E Only for use in topical medicines for dermal application. 4464 SCOPOLIA CARNIOLICA A, H The concentration of equivalent dry Scopolia carniolica in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%. 4465 SCROPHULARIA NINGPOENSIS A, H 4466 SCROPHULARIA NODOSA A, H 4467 SCURRULA PARASITICA VAR. GRACILIFLORA A, H 4468 SCUTELLARIA BAICALENSIS A, E, H 4469 SCUTELLARIA BARBATA A, H 4470 SCUTELLARIA LATERIFLORA A, E, H 4471 SEA WHIP EXTRACT E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.02%. 4472 SEC BUTYL 3-METHYLBUT-2-ENETHIOATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4473 SEC-BUTYL THIOISOVALERATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4474 SECALE CEREALE A, H Gluten is a mandatory component of Secale cereale when the plant part is seed and the route of administration is other than topical and mucosal. 4475 SEDUM ACRE A, H 4476 SELAGINELLA TAMARISCINA A, H 4477 SELENICEREUS GRANDIFLORUS A, E, H 4478 SELENIUM H Only for use as an active homoeopathic ingredient. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.' 4479 SELENOCYSTEINE A Selenium is a mandatory component of Selenocysteine for oral and sublingual use. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 mcg for adults of selenium from dietary supplements should not be exceeded.' 4480 SELENOMETHIONINE A Selenium is a mandatory component of Selenomethionine for oral and sublingual use. Oral medicines must not contain more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.' 4481 SELF-EMULSIFYING GLYCERYL MONOSTEARATE E 4482 SEMECARPUS ANACARDIUM A, H When the plant part is other than seed, the maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material. 4483 SEMOLINA E 4484 SEMPERVIVUM TECTORUM A, H 4485 SENEGA ROOT DRY A, H 4486 SENEGA ROOT POWDER A, H 4487 SENNA ALEXANDRINA A, H When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna alexandrina. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4488 SENNA FRUIT ALEXANDRIAN DRY A, H When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit alexandrian dry. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4489 SENNA FRUIT ALEXANDRIAN POWDER A, H When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit alexandrian powder. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4490 SENNA FRUIT TINNEVELLY DRY A, H When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit tinnevelly dry. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4491 SENNA FRUIT TINNEVELLY POWDER A, H When for oral or sublingual, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit tinnevelly powder. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4492 SENNA LEAF DRY A, H When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna leaf dry. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4493 SENNA LEAF POWDER A, H When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna Leaf Powder. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4494 SENNA OCCIDENTALIS A, H Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna occidentalis when the route of administration is oral administration. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect]. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' [or words to that effect]. When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended; - (LAX1) 'Drink plenty of water' [or words to that effect]; and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4495 SENNA TORA A, H When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna tora. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'. 4496 SEPIA H Only for use as an active homoeopathic ingredient. The following warning statement is required on the medicine label: - (MOLLUSC) 'Contains mollusc' or 'Contains mollusc products'. 4497 SEQUOIA SEMPERVIRENS A, H 4498 SEQUOIADENDRON GIGANTEUM A, H 4499 SERENOA REPENS A, H 4500 SERINE A, E 4501 SERUM ANGUILLAE H Only for use as an active homoeopathic ingredient. 4502 SESAME OIL A, E, H 4503 SESAMUM INDICUM A, E, H 4504 SETARIA ITALICA A, H 4505 SHARK CALCIUM CHONDROITIN SULFATE A 4506 SHARK CARTILAGE A, E The medicine requires the following warning statement on the medicine label: - (SHARK) 'Children, pregnant or breastfeeding women, and those who have recently had a heart attack, surgery or a major accident should not consume this product without medical advice' (or words to that effect) 4507 SHARK CHONDROITIN SULFATE A, E When used as an excipient: - only for use in topical medicines for dermal application; - not to be included in medicines intended for use in the eye; and - the concentration in the medicine must be no more than 0.001%. 4508 SHARK POTASSIUM CHONDROITIN SULFATE A 4509 SHARK SODIUM CHONDROITIN SULFATE A, E When used as an excipient: - only for use in topical medicines for dermal application; - not to be included in medicines intended for use in the eye; and - the concentration in the medicine must be no more than 0.001%. 4510 SHARK-LIVER OIL A, E Vitamin A and Colecalciferol are mandatory components of Shark-liver oil. When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) 'WARNING: If you are pregnant - or considering becoming pregnant - do not take vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].' NOTE: Position this warning at the beginning of the directions for use. - (VITA4) 'WARNING - When taken in excess of 3000 micrograms retinol equivalents - vitamin A can cause birth defects.' NOTE: Position this warning at the beginning of the directions for use. - (VITA3) 'The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.' 4511 SHEA BUTTER E 4512 SHEA BUTTER ETHYL ESTERS E Shea butter ethyl esters must: (a) Only be used in topical medicines for dermal application; and (b) Not be included in medicines intended for use on broken skin. The total concentration of shea butter ethyl esters in the medicine must not be more than 30%. 4513 SHEA BUTTER UNSAPONIFIABLES E Only for use in topical medicines for dermal application. 4514 SHELLAC E 4515 SHEPHERD'S PURSE HERB DRY A, H 4516 SHEPHERD'S PURSE HERB POWDER A, H 4517 SHERRY WINE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4518 SIGESBECKIA ORIENTALIS A, E, H 4519 SILICA E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4520 SILICA DIMETHYL SILYLATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. 4521 SILICA SILYLATE E Only for use in topical medicines for dermal application. 4522 SILICIFIED MICROCRYSTALLINE CELLULOSE E Only for use when the route of administration is other than inhalation. 4523 SILICON DIOXIDE A, E, H Only for use when the route of administration is other than inhalation. 4524 SILICONE QUATERNIUM-8 E Only for use in wash-off topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2.5%. The medicine requires the following warning statement on the medicine label: - (EYE) 'Avoid contact with eyes' (or words to that effect). 4525 SILVER H Only for use as an active homoeopathic ingredient. When for external use, the total concentration of silver in the medicine must not be more than 1%. When for oral use: (a) the total concentration of silver in the medicine must not be more than 0.3%; and (b) the following warning statement is required on the medicine label: - 'Overuse may stain skin or mouth.' (or words to that effect). 4526 SILVER BOROSILICATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine should be no more than 0.6%. Silver is a mandatory component of Silver borosilicate when the route of administration is topical. The concentration of silver in the medicine must be no more than 1%. 4527 SILVER NITRATE H Only for use as an active homoeopathic ingredient. 4528 SILYBUM MARIANUM A, E, H 4529 SIMABA CEDRON A, H 4530 SIMETHICONE E 4531 SIMMONDSIA CHINENSIS A, E, H 4532 SINAPIS ALBA A, H Allyl isothiocyanate is a mandatory component of Sinapis alba when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. 4533 SINAPIS ARVENSIS A, H 4534 SINOMENIUM ACUTUM A, H 4535 SIPHONESTEGIA CHINENSIS A, H 4536 SIRAITIA GROSVENORII A, E, H 4537 SISYMBRIUM OFFICINALE A, H 4538 SKATOLE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4539 SKIPJACK-LIVER OIL A, E Vitamin A and Colecalciferol are mandatory components of Skipjack-liver oil. When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) 'WARNING: If you are pregnant - or considering becoming pregnant - do not take vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].' NOTE: Position this warning at the beginning of the directions for use. - (VITA4) 'WARNING - When taken in excess of 3000 micrograms retinol equivalents - vitamin A can cause birth defects.' NOTE: Position this warning at the beginning of the directions for use. - (VITA3) 'The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.' 4540 SLIPPERY ELM BARK DRY A, H 4541 SLIPPERY ELM BARK POWDER A, E, H 4542 SMILAX ARISTOLOCHIIFOLIA A, H 4543 SMILAX CHINA A, H 4544 SMILAX GLABRA A, H 4545 SMILAX OFFICINALIS A, E, H 4546 SMILAX ORNATA A, E, H 4547 SMOKE EXTRACT E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4548 SODIUM ACETATE E 4549 SODIUM ACETYLATED HYALURONATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 4550 SODIUM ACID CITRATE A, E, H When sodium acid citrate is used as an active ingredient, only for use in oral medicines. 4551 SODIUM ACRYLATES COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.8%. 4552 SODIUM ACRYLATES CROSSPOLYMER-2 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.7 % (w/w). 4553 SODIUM ACRYLOYDIMETHYLTAURATE/VP CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2% (w/w). 4554 SODIUM ALGINATE E 4555 SODIUM ASCORBATE A, E, H 4556 SODIUM ASCORBYL PHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. When used in a sunscreen, the concentration in the medicine must be no more than 0.1%. When used in products other than sunscreens, the concentration in the medicine must be no more than 0.5%. 4557 SODIUM ASCORBYL/CHOLESTERYL PHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 4558 SODIUM BENZOATE E 4559 SODIUM BETA-HYDROXY-BETA-METHYLBUTYRATE A, H 4560 SODIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE A, H 4561 SODIUM BICARBONATE A, E When used as an active ingredient, the medicine may only be for oral rehydration salts in powdered and effervescent tablet dosage forms. Medicines containing sodium bicarbonate for use as oral rehydration therapy are subject to the following conditions: a) the medicine complies with the requirements specified in the British Pharmacopoeia, as in force or existing from time to time, for Oral Rehydration Salts; b) the sodium content and total osmolarity of the solution after it has been prepared according to the instructions on the packet are consistent with the criteria specified by the World Health Organisation (WHO) and the United Nations Childrens Fund (UNICEF) in the document 'Expert consultation on oral rehydration salts formulation 18 July 2001.' c) the following warning statements are required on the medicine label: - (UOAD) 'Use only as directed.' - (DIAR) 'If diarrhoea persists for more than 6 hours in infants under 6 months - 12 hours in children under 3 years - 24 hours in children aged 3-6 years or 48 hours in adults and children over 6 years - seek medical advice (or words to that effect).' - (DIAR3) 'If diarrhoea persists, seek medical advice.' 4562 SODIUM BISULFITE E 4563 SODIUM BROMIDE H Only for use as an active homoeopathic ingredient. The total concentration of sodium bromide in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 4564 SODIUM BUTYRATE A, E The route of administration for medicines that contain sodium butyrate must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 1200 mg sodium butyrate. The following warning statement (or words to the same effect) is required on the medicine label: - (ADULT) 'Adults only'. 4565 SODIUM C14-16 OLEFIN SULFONATE E Only for use in topical medicines for dermal application. 4566 SODIUM CALCIUM EDETATE E When for oral use, sodium is a mandatory component of sodium calcium edetate. Sodium calcium edetate must only be included in medicines when: (a) the route of administration is limited to topical for dermal use; or (b) in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of sodium calcium edetate in the medicine must not exceed 0.32%. The total concentration of flavour proprietary excipient formulations containing sodium calcium edetate must not be more than 5% of the total medicine. 4567 SODIUM CARBOMER E Only for use as an excipient in topical medicines for dermal application. 4568 SODIUM CARBONATE E When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 4569 SODIUM CARBONATE MONOHYDRATE E When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 4570 SODIUM CARBOXYMETHYL BETAGLUCAN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.005%. 4571 SODIUM CARRAGEENAN E 4572 SODIUM CASEINATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4573 SODIUM CETOSTEARYL SULFATE E Only for use in topical medicines for dermal application. 4574 SODIUM CHLORIDE A, E, H 4575 SODIUM CHONDROITIN SULFATE A, E When used as an excipient ingredient: a) only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye; b) the concentration in the medicine must not be more than 0.001%. When used as an active ingredient: a) the route of administration must only be oral; b) the maximum daily dose must not provide more than 1,200 mg of sodium chondroitin sulfate; c) the following statements must be included on the medicine label: - (ADULT) 'Adults only' (or words to that effect); - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect). 4576 SODIUM CITRATE A, E When for use as an active ingredient, only for oral use. 4577 SODIUM CITRATE DIHYDRATE A, E When for use as an active ingredient, only for oral use. 4578 SODIUM COCO PG-DIMONIUM CHLORIDE PHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.05%. 4579 SODIUM COCOAMPHOACETATE E Only for use in topical medicines for dermal application. 4580 SODIUM COCOYL SARCOSINATE E Only for use in topical medicines for dermal application. 4581 SODIUM CYCLAMATE E 4582 SODIUM DEHYDROACETATE E Only for use in topical medicines for dermal application. 4583 SODIUM DNA E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 4584 SODIUM DODECYLBENZENESULFONATE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 30%. 4585 SODIUM ERYTHORBATE E 4586 SODIUM ETHYL HYDROXYBENZOATE E 4587 SODIUM FLUORIDE A, E, H Fluoride is a mandatory component of sodium fluoride. The route of administration must be limited to dental. The dosage form must be limited to pastes, powders and/or gels for dental hygiene. When used as an active ingredient, the medicine is subject to the following conditions: (a) only for use in combination with at least one other active ingredient; and (b) the concentration of fluoride ion in the medicine must not be more than 1,500 mg/kg. When the concentration of fluoride ion is more than 1000 mg/kg, the medicine requires the following statements on the medicine label: - (DNTSW) 'Do not swallow.' - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less.' 4588 SODIUM FUMARATE E 4589 SODIUM HYALURONATE A, E When for use as an excipient ingredient, sodium hyaluronate must only be used in medicines with a topical route of administration for dermal application. When for use as an active ingredient: (a) the molecular mass of sodium hyaluronate must be between 600 and 1600 kilodaltons; and (b) sodium hyaluronate must only be used in medicines when the route of administration is limited to: (i) topical for dermal application; or (ii) oral. When for use in a topical medicine for dermal application the concentration of sodium hyaluronate in the medicine must not exceed 2.0%. When for use as an active ingredient and the route of administration is oral: (a) the maximum recommended daily dose must not provide more than 200 milligrams sodium hyaluronate; (b) the recommended duration of use of the medicine must be limited to three months; and (c) the following warning statements (or words to the same effect) are required on the medicine label : - (ADULT) 'Adults only'; and - (PREGNT) ' Not recommended for use by pregnant and lactating women'. 4590 SODIUM HYDROGENATED TALLOW GLUTAMATE E Only for use in topical medicines for dermal application. 4591 SODIUM HYDROXIDE E The concentration of sodium hydroxide in the medicine must not be more than 5%. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 4592 SODIUM HYDROXYCITRATE A The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. When for oral use, the following warning statement is required on the medicine label: 'In very rare cases, sodium hydroxycitrate may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.' Medicines containing sodium hydroxycitrate must not be directed for use in children, or in pregnant or lactating women. 4593 SODIUM HYDROXYETHYL ACRYLATE/ACRYLOYLDIMETHYL TAURATE COPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%. 4594 SODIUM HYDROXYMETHYLGLYCINATE E Only for use in topical medicines for dermal application. 4595 SODIUM HYPOCHLORITE E The pH of the sodium hypochlorite preparation must be less than 11.5. 4596 SODIUM ISOSTEAROYL LACTYLATE E Only for use in topical medicines for dermal application. 4597 SODIUM LACTATE E 4598 SODIUM LAURETH SULFATE E 4599 SODIUM LAUROAMPHOACETATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 4600 SODIUM LAUROYL LACTYLATE E Sodium lauroyl lactylate must: (a) Only be used in topical medicines for dermal application; and (b) Not be included in medicines intended for use on broken skin or in the eye. The concentration in the medicine must be no more than 0.2%. 4601 SODIUM LAUROYL METHYL ISETHIONATE E Only for use in wash-off topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 11%. 4602 SODIUM LAUROYL SARCOSINATE E Only for use in topical medicines for dermal application. 4603 SODIUM LAURYL PHOSPHATE E 4604 SODIUM LAURYL SULFATE E 4605 SODIUM LAURYL SULFOACETATE E Only for use in topical medicines for dermal application. 4606 SODIUM MAGNESIUM SILICATE E Only for use in topical medicines for dermal application. 4607 SODIUM MANNOSE PHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. 4608 SODIUM METABISULFITE E 4609 SODIUM METAPHOSPHATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or damaged skin. The concentration in the medicine must not be more than 0.1%. 4610 SODIUM METHYL COCOYL TAURATE E Only for dental use. The concentration in the medicine must be no more than 2%. 4611 SODIUM METHYL HYDROXYBENZOATE E 4612 SODIUM MOLYBDATE DIHYDRATE A Only for use in oral medicines. Molybdenum is a mandatory component of Sodium molybdate dihydrate. The percentage of molybdenum from sodium molybdate dihydrate should be calculated based on the molecular weight of sodium molybdate dihydrate. The maximum daily dose of molybdenum from Sodium molybdate dihydrate must be no more than 125 micrograms. 4613 SODIUM MONOFLUOROPHOSPHATE A Fluoride is a mandatory component of sodium monofluorophosphate. The route of administration must be limited to dental. The dosage form must be limited to pastes, powders and/or gels for dental hygiene. When sodium monofluorophosphate is used as an active ingredient, it is subject to the following conditions: (a) only for use in combination with at least one other active ingredient; and (b) the concentration of fluoride ion in the medicine must not be more than 1,500 mg/kg. When the concentration of fluoride ion is more than 1000 mg/kg, the following warning statements are required on the medicine label: - (DNTSW) 'Do not swallow.' - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less.' 4614 SODIUM MYRISTOYL GLUTAMATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.0164%. 4615 SODIUM NITRATE H Only for use as an active homoeopathic ingredient. 4616 SODIUM NONOXYNOL-4 SULFATE E Only for use in topical medicines for dermal application. 4617 SODIUM PANTOTHENATE A, E, H 4618 SODIUM PCA E Only for use in topical medicines for dermal application. 4619 SODIUM PERBORATE A, H Boron is a mandatory component of sodium perborate. When for internal use, the maximum recommended daily dose must not provide more than 6 mg of boron. When used in preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron from all ingredients in the product must not exceed 3500 mg/kg or 3500 mg/L or 0.35%. When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label: - (NTAKEN12) 'Not to be taken by children under 12 years old' (or words to that effect); or - (ADULT) 'Adults only' (or words to that effect). When the maximum recommended daily dose of the medicine provides more than 1 mg boron and up to, and including, 3 mg of boron, and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label: - (NTAKEN2) 'Not to be taken by children under 2 years old' (or words to that effect); or - (ADULT) 'Adults only' (or words to that effect). When for excipient use and the maximum recommended daily dose of the medicine provides more than 1 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label: - (BORON) 'Contains boron' (or words to that effect). When the medicine is for topical use for dermal application, the following warning statement is required on the label: - (BROKEN) 'Use on unbroken skin only' (or words to that effect). 4620 SODIUM PERCARBONATE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 15%. 4621 SODIUM POLYACRYLATE E Only for use in topical medicines for dermal application. 4622 SODIUM POLYACRYLATE STARCH E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 1%. 4623 SODIUM POLYMETAPHOSPHATE E 4624 SODIUM PROPIONATE E 4625 SODIUM PROPYL HYDROXYBENZOATE E 4626 SODIUM RNA E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. 4627 SODIUM SELENATE A, H Selenium is a mandatory component of sodium selenate. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.' 4628 SODIUM SELENATE DECAHYDRATE A Selenium is a mandatory component of sodium selenate decahydrate. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.' 4629 SODIUM SELENITE A, H Selenium is a mandatory component of Sodium selenite. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.' 4630 SODIUM SELENITE PENTAHYDRATE A Selenium is a mandatory component of Sodium selenite pentahydrate. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.' 4631 SODIUM SILICATE E 4632 SODIUM STARCH GLYCOLLATE E 4633 SODIUM STARCH GLYCOLLATE TYPE A E 4634 SODIUM STEARATE E Only for use in topical medicines for dermal application. 4635 SODIUM STEAROXY PG-HYDROXYETHYLCELLULOSE SULFONATE E Only for use in topical medicines for dermal application and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 4636 SODIUM STEAROYL GLUTAMATE E Only for use in topical medicines for dermal application and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 2.5%. 4637 SODIUM STEAROYL LACTYLATE E Only for use in topical medicines for dermal application. 4638 SODIUM STEARYL PHTHALAMATE E Only for use in medicines for dermal application and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%. 4639 SODIUM SUCCINATE E Only for use in topical medicines for dermal application. 4640 SODIUM SULFATE A, E, H When it is not intended to be a laxative, the following warning statement is required on the medicine label: - (LAX4) 'Substance may have a laxative effect'. 4641 SODIUM SULFATE DECAHYDRATE A, E, H When it is not intended to be a laxative, the following warning statement is required on the medicine label: - (LAX4) 'Substance may have a laxative effect'. 4642 SODIUM SULFITE E 4643 SODIUM SULFITE HEPTAHYDRATE E Only for use in topical medicines for dermal application. 4644 SODIUM TRIPOLYPHOSPHATE E Only for use when the route of administration is topical for dermal application, mucous membrane (buccal mucosa) or dental. Not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 4645 SOLANUM DULCAMARA A, H When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum dulcamara. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine. 4646 SOLANUM FEROX A, H When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum ferox. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine. 4647 SOLANUM LYCOCARPUM FRUIT EXTRACT E Only for use in topical medicines for dermal use and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 0.02%. 4648 SOLANUM MELONGENA A, H When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum melongena. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine. 4649 SOLANUM NIGRUM A, H When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum nigrum. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine. 4650 SOLANUM TUBEROSUM A, H When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum tuberosum. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine. 4651 SOLIDAGO GIGANTEA A, H 4652 SOLIDAGO GIGANTEA MIS A, E, H 4653 SOLIDAGO VIRGAUREA A, E, H 4654 SOLUBLE MAIZE STARCH E 4655 SOLUBLE POTATO STARCH E 4656 SOLVENT GREEN 3 E Permitted for use only as a colour for topical use. 4657 SOLVENT RED 1 E Permitted for use only as a colour for topical use. 4658 SOLVENT VIOLET 13 E Permitted for use only as a colour for topical use. 4659 SOLVENT YELLOW 172 E Permitted for use only as a colour for topical use. The concentration in the medicine must be no more than 0.3%. 4660 SOLVENT YELLOW 33 E Permitted for use only as a colour for topical use. 4661 SOPHORA FLAVESCENS A, E, H 4662 SOPHORA TONKINENSIS A, H 4663 SORBIC ACID E 4664 SORBITAN ISOSTEARATE E Only for use in topical medicines for dermal application. 4665 SORBITAN MONO-OLEATE E 4666 SORBITAN MONOLAURATE E 4667 SORBITAN MONOSTEARATE E 4668 SORBITAN OLEATE E 4669 SORBITAN OLIVATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. 4670 SORBITAN PALMITATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. 4671 SORBITAN SESQUIISOSTEARATE E Only for use in topical medicines for dermal application. 4672 SORBITAN SESQUIOLEATE E Only for use in topical medicines for dermal application. 4673 SORBITAN STEARATE E 4674 SORBITAN TRISTEARATE E Only for use in topical medicines for dermal application. 4675 SORBITOL A, E When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 4676 SORBITOL SOLUTION (70 PER CENT) (CRYSTALLISING) A, E Sorbitol is a mandatory component of sorbitol solution (70 per cent) (crystallising). When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 4677 SORBITOL SOLUTION (70 PER CENT) (NON-CRYSTALLISING) A, E Sorbitol is a mandatory component of sorbitol solution (70 per cent) (non-crystallising). When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 4678 SORBUS AUCUPARIA A, H 4679 SORGHUM E 4680 SORGHUM VULGARE A, H 4681 SOY PHOSPHATIDYLSERINE-ENRICHED SOY LECITHIN LIQUID A Soy phosphatidylserine is a mandatory component of soy phosphatidylserine-enriched soy lecithin liquid. The maximum recommended daily dose of the medicine must not provide more than 300 mg of soy phosphatidylserine. 4682 SOY PHOSPHATIDYLSERINE-ENRICHED SOY LECITHIN POWDER A Soy phosphatidylserine is a mandatory component of soy phosphatidylserine-enriched soy lecithin powder. The maximum recommended daily dose of the medicine must not provide more than 300 mg of soy phosphatidylserine. 4683 SOY POLYSACCHARIDE E 4684 SOY PROTEIN E 4685 SOY STEROL E 4686 SOYA BEAN E 4687 SOYA OIL A, E, H 4688 SOYBEAN FLOUR E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4689 SOYBEAN GLYCERIDES E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. 4690 SPARGANIUM STOLONIFERUM A, H 4691 SPARTIUM JUNCEUM A, H 4692 SPATHOLOBUS SUBERECTUS A, H 4693 SPEARMINT OIL A, E, H Menthol is a mandatory component of spearmint oil. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 4694 SPEARMINT OIL TERPENELESS E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. Menthol is a mandatory component of spearmint oil terpeneless. When the medicine is for topical use for dermal application: i) the medicine must not be intended for use in the eye or on damaged skin; ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. 4695 SPHINGOLIPIDS E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 4696 SPIGELIA ANTHELMIA A, H 4697 SPIGELIA MARILANDICA A, H The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material. 4698 SPIKE LAVENDER OIL A, E, H Camphor is a mandatory component of spike lavender oil. In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%. In liquid preparations other than essential oils, the concentration of camphor must be no more than 2.5%. In essential oil preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. If the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25 millilitres. 4699 SPINACH E 4700 SPINACIA OLERACEA A, E, H 4701 SPIRODELA POLYRRHIZA A, H 4702 SPIRULINA E 4703 SPRAY-DRIED GLUCOSE SYRUP E Permitted for use as an excipient for oral routes of administration. 4704 SPRAY-DRIED LIQUID GLUCOSE E Permitted for use as an excipient for oral routes of administration. 4705 SPRUCE OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4706 SQUALANE E Only for use in topical medicines for dermal application. 4707 SQUALENE A, E 4708 SQUID OIL A Only for use in oral medicines. Must be obtained from species of the order Teuthida of the class Cephalopoda, be used in combination with other ingredients in the medicine and be presented in a therapeutic dosage form for therapeutic use. The following warning statement is required on the medicine label: - (MOLLUSC) 'Contains mollusc' or 'Contains mollusc products'. 4709 SQUILL DRY A, H 4710 SQUILL INDIAN DRY A, H 4711 SQUILL INDIAN POWDER A, H 4712 SQUILL POWDER A, H 4713 ST JOHN'S WORT DRY EXTRACT QUANTIFIED A When used for oral ingestion, the medicine requires the following warning statement on the medicine label: - (STJOHN) 'St John's Wort affects the way many prescription medicines work - including oral contraceptives. Consult your doctor.' 4714 ST JOHN'S WORT HERB DRY A, H When used for oral ingestion, the medicine requires the following warning statement on the medicine label: - (STJOHN) 'St John's Wort affects the way many prescription medicines work - including oral contraceptives. Consult your doctor.' 4715 ST JOHN'S WORT HERB POWDER A, H When used for oral ingestion, the medicine requires the following warning statement on the medicine label: - (STJOHN) 'St John's Wort affects the way many prescription medicines work - including oral contraceptives. Consult your doctor.' 4716 STACHYS OFFICINALIS A, E, H 4717 STACHYS PALUSTRIS A, H 4718 STACHYURUS HIMALAICUS A, H 4719 STANNIC OXIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.005%. 4720 STANNOUS CHLORIDE H Only for use as an active homoeopathic ingredient. 4721 STAR ANISE OIL A, E When the total concentration of star anise oil in the medicine is more than 50%: (a) the nominal capacity of the container must not be more than 50 mL; (b) a restricted flow insert must be fitted on the container; and (c) the following warning statement is required on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). 4722 STARCH E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4723 STARCH SODIUM OCTENYL SUCCINATE E 4724 STEARALKONIUM CHLORIDE E Only for use in topical medicines for dermal application. 4725 STEARALKONIUM HECTORITE E Only for use in topical medicines for dermal application. 4726 STEARAMIDE E Only for use in topical medicines for dermal application. 4727 STEARAMIDOETHYL DIETHYLAMINE E Only for use in topical medicines for dermal application. 4728 STEARAMIDOPROPYL DIMETHYLAMINE E Only for use in topical medicines for dermal application. 4729 STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 2%. When the medicine is intended to be used on the eye, the medicine requires the following warning statement on the medicine label: - (EYE2) 'May be irritant to the eyes' (or words to that effect). 4730 STEARETH-10 E Only for use in topical medicines for dermal application. 4731 STEARETH-100 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%. 4732 STEARETH-2 E Only for use in topical medicines for dermal application. 4733 STEARETH-20 E Only for use in topical medicines for dermal application. 4734 STEARETH-21 E Only for use in topical medicines for dermal application. 4735 STEARETH-5 E Only for use in topical medicines for dermal application. 4736 STEARIC ACID E 4737 STEAROPTENES E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4738 STEAROXY DIMETHICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. 4739 STEAROXYTRIMETHYLSILANE E Only for use in topical medicines for dermal application. 4740 STEAROYL MACROGOLGLYCERIDES E Only for use in oral medicines. The concentration in the medicine must be no more than 0.6%. 4741 STEARYL ACETATE E Only for use in topical medicines for dermal application. 4742 STEARYL ALCOHOL E 4743 STEARYL BEHENATE E Only for use as an excipient ingredient for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 3.5% in the final formulation. 4744 STEARYL DIMETHICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4.5%. The medicine requires the following warning statements on the medicine label: - (EYE2) 'May be irritant to the eyes' (or words to that effect) - (EYE) 'Avoid contact with eyes' (or words to that effect). 4745 STEARYL GLYCYRRHETINATE E Only for use in topical medicines for dermal application. 4746 STEARYL HEPTANOATE E Only for use in topical medicines for dermal application. 4747 STEARYL MYRISTATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4748 STEARYL STEARATE E Only for use in topical medicines for dermal application. 4749 STELLARIA CHAMAEJASME A, H 4750 STELLARIA DICHOTOMA A, H 4751 STELLARIA MEDIA A, E, H 4752 STEMONA JAPONICA A, H 4753 STEMONA SESSILIFOLIA A, H 4754 STENOTAPHRUM SECUNDATUM A, H 4755 STEPHANIA TETRANDA A, H 4756 STERCULIA A, H 4757 STERCULIA TRAGACANTHA A, H 4758 STERCULIA URENS A, H 4759 STEVIA REBAUDIANA A, E, H 4760 STEVIOL GLYCOSIDES E Only for use in oral medicines. 4761 STILLINGIA SYLVATICA A, H 4762 STORAX PREPARED A, E, H 4763 STRAWBERRY E 4764 STRAWBERRY ESSENCE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4765 STREPTOCOCCUS SALIVARIUS A Only permitted for use in medicines: - that are for oral routes of administration; and - when the strain of Streptococcus salivarius is confirmed to be K12 or M18. The name of the Streptococcus salivarius strain must be declared on the label. The following warning statement is required on the medicine label: - (CHILD5) 'Use in children under 3 years is not recommended'. 4766 STREPTOCOCCUS THERMOPHILUS A 4767 STROBILANTHES CUSIA A, H 4768 STRONG AMMONIA SOLUTION E Ammonia is a mandatory component of strong ammonia solution. The concentration of ammonia in the medicine must be no more than 0.5%. When for internal use, the concentration in the medicine must be no more than 0.25%. 4769 STRONTIUM CARBONATE H Only for use as an active homoeopathic ingredient. 4770 STROPHANTHUS GRATUS H Only for use as an active homoeopathic ingredient. 4771 STROPHANTHUS HISPIDUS H Only for use as an active homoeopathic ingredient. 4772 STRYCHNOS IGNATII H Only for use as an active homoeopathic ingredient. Strychnine (of Strychnos spp.) is a mandatory component of Strychnos ignatii. The concentration of Strychnine (of Strychnos spp.) must not be more than 1 milligram/Kg or 1 milligram/L or 0.0001%. 4773 STRYCHNOS NUX-VOMICA A, H Strychnine (of Strychnos spp.) is a mandatory component of Strychnos nux-vomica. The concentration of Strychnine (of Strychnos spp.) must not be more than 1 milligram/Kg or 1 milligram/L or 0.0001%. 4774 STYPHNOLOBIUM JAPONICUM A, E, H 4775 STYRALLYL PROPIONATE E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%. 4776 STYRAX BENZOIN A, E, H 4777 STYRAX OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4778 STYRAX PARALLELONEURUM A, H 4779 STYRAX TONKINENSIS A, H 4780 STYRENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. The total concentration of styrene in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 4781 STYRENE/ACRYLATES COPOLYMER E Only for use in topical medicines for dermal application. 4782 STYROLYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4783 SUBLIMED SULFUR H Only for use as an active homoeopathic ingredient. 4784 SUCCINIC ACID E 4785 SUCRALOSE E 4786 SUCROSE E 4787 SUCROSE ACETATE ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4788 SUCROSE ACETATE PALMITATE STEARATE E Only for use in topical medicines for dermal application and not intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.3%. 4789 SUCROSE COCOATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. 4790 SUCROSE DISTEARATE E Only for use in topical medicines for dermal application. 4791 SUCROSE LAURATE E When for oral or sublingual use, sucrose is a mandatory component of sucrose laurate. 4792 SUCROSE OCTAACETATE E When for oral or sublingual use, sucrose is a mandatory component of sucrose octaacetate. 4793 SUCROSE PALMITATE E Only for use in topical medicines for dermal application. 4794 SUCROSE POLYCOTTONSEEDATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. The medicine requires the following warning statements on the medicine label: - (EYE) 'Avoid contact with the eyes' (or words to that effect) - (EYE2) 'May be irritant to the eyes' (or words to that effect). 4795 SUCROSE STEARATE E For use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. When for topical use, the concentration in the medicine must be no more than 0.25%. For oral use as a manufacturing aid only. When for oral use, the concentration in the medicine must be no more than 0.2 mg per dosage unit. 4796 SUCROSE TRISTEARATE E Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. 4797 SUDAN III E Permitted for use only as a colour for topical use. 4798 SUGAR CANE WAX ALCOHOLS A, H The routes of administration for medicines that contain sugar cane wax alcohols must be limited to: (a) topical for dermal use; and (b) oral. When for use in topical medicines, the maximum recommended daily dose of the medicine must not provide more than 12 mg of sugar cane wax alcohols. When for oral use: (a) the maximum recommended daily dose of the medicine must not provide more than: (i) 12 mg of sugar cane wax alcohols for individuals aged less than 18 years; and (ii) 20 mg of sugar cane wax alcohols for individuals aged 18 years and above. (b) The following warning statement (or words to the same effect) is required on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women'. (c) If the maximum recommended daily dose of the medicine contains 20 mg of sugar cane wax alcohols, the following warning statement is also required on the medicine label: - (ADULTS) 'Adults only'. 4799 SUGARCANE E, H When for oral or sublingual use, sucrose is a mandatory component of sugarcane. 4800 SULFATED CASTOR OIL E Only for use in topical medicines for dermal application. 4801 SULFATED LOW MOLECULAR WEIGHT FUCANS E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.025%. 4802 SULFUR DIOXIDE E 4803 SULFUR IODIDE H Only for use as an active homoeopathic ingredient. 4804 SULFURIC ACID E, H Only for use as an active homoeopathic ingredient or excipient ingredient. The concentration in the medicine must be no more than 0.5%. 4805 SULFURISED 1-METHYL-4-(1-METHYLETHENYL)-CYCLOHEXENE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4806 SULISOBENZONE A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 4807 SULISOBENZONE SODIUM A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 4808 SUNFLOWER OIL A, E, H 4809 SUNFLOWER SEED E, H 4810 SUNSET YELLOW FCF E Permitted for use only as a colour for either topical use or with an oral route of administration. 4811 SUNSET YELLOW FCF ALUMINIUM LAKE E Permitted for use only as a colour in medicines limited to topical and oral routes of administration. 4812 SUPEROXIDE DISMUTASE E Only for use in topical medicines for dermal application. 4813 SWEDE E 4814 SWEET ORANGE OIL TERPENES AND TERPENOIDS E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4815 SWEET POTATO E 4816 SWERTIA CHIRATA A, H 4817 SWIETENIA MAHOGANI A, H 4818 SYAGRUS ROMANZOFFIANA A, E, H 4819 SYMPHYOTRICHUM NOVI-BELGII A, H 4820 SYMPHYTUM OFFICINALE H When used orally as an active homoeopathic ingredient, the concentration must be a dilution of 12X or more. When used in topical medicines for dermal application, the concentration in the preparation must be no more than 10mg/kg or 10mg/L or 0.001%. 4821 SYMPLOCARPUS FOETIDUS A, H 4822 SYNTHETIC BEESWAX E Only for use in topical medicines for dermal applications. 4823 SYNTHETIC TERPENE RESIN E Only for use in topical, oral or oral application medicines. When the route of administration is oral, the dosage form must be chewing gum. 4824 SYNTHETIC WAX E 4825 SYRINGA RETICULATA A, H 4826 SYRINGA VULGARIS A, H 4827 SYZYGIUM AROMATICUM A, E, H When the plant preparation is oil or distillate and the concentration of this oil or distillate in the product is greater than 25%, the nominal capacity of the container must be no more than 25 millilitres and the medicine must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. When the plant preparation is oil or distillate, the concentration of this oil or distillate in the medicine is greater than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, a child resistant closure and restricted flow insert must be fitted on the container. When the plant preparation is oil or distillate, the concentration of oil or distillate in the product is greater than 25% and the nominal capacity of the container is less than 15 millilitres, a restricted flow insert must be fitted on the container. When the plant preparation is oil or distillate and the preparation is for topical use in the mouth, the preparation may not contain more than 5 millilitres of the oil or distillate and the concentration of oil or distillate in the product must not be greater than 25%. 4828 SYZYGIUM CUMINI A, H 4829 SYZYGIUM JAMBOS E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 0.0693%. 4830 TABEBUIA SERRATIFOLIA A, E, H 4831 TADEHAGI TRIQUETRUM A, H 4832 TAGETES ERECTA A, E, H When used as an excipient ingredient, only for use in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must not be more than 5%. 4833 TAGETES MINUTA A, E, H 4834 TAGETES OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4835 TAIPAN SNAKE H Only for use as an active homoeopathic ingredient. 4836 TALLOW E Only for use in topical medicines for dermal application. 4837 TALLOW GLYCERIDES E 4838 TAMARINDUS INDICA E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4839 TAMARIX APHYLLA A, H 4840 TAMARIX CHINENSIS A, H 4841 TAMARIX GALLICA A, H 4842 TAMUS COMMUNIS A, H If the plant part is fruit or root, the maximum recommended daily dose must be no more than 1mg of the equivalent dry fruit or dry root of Tamus communis. 4843 TANACETUM CINERARIIFOLIUM A, H The concentration in the medicine must be no more than 10%. 4844 TANACETUM COCCINEUM SUBSP. COCCINEUM A, H 4845 TANACETUM PARTHENIUM A, E, H 4846 TANACETUM VULGARE A, H Oil (of Tanacetum vulgare) is a mandatory component of Tanacetum vulgare. The concentration of oil (of Tanacetum vulgare) in the medicine must be no more than 0.8%. 4847 TANGERINE OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4848 TANGERINE OIL COLDPRESSED A, E, H When used internally, oxedrine is a mandatory component of tangerine oil coldpressed. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. 4849 TANNIC ACID E 4850 TAPIOCA STARCH E 4851 TARAXACUM MONGOLICUM A, E, H 4852 TARAXACUM OFFICINALE A, E, H 4853 TARO E 4854 TARRAGON OIL A, E, H 4855 TARTARIC ACID E 4856 TARTRAZINE E Only for use as a colour. Only for use in medicines for topical and oral administration. 4857 TARTRAZINE ALUMINIUM LAKE E Only for use as a colour. Only for use in medicines for topical and oral administration. 4858 TASMANNIA LANCEOLATA E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4859 TAURINE A, E 4860 TEA-STEARATE E Only for use in topical medicines for dermal application. 4861 TERMINALIA ARJUNA A Only for use in oral medicines. Only for use when the plant part is bark. The maximum recommended daily dose must be no more than 6 grams of Terminalia arjuna dried bark or its extract equivalents. The medicine requires the following warning statements on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect) - (CHILD2) 'Not suitable for children'. 4862 TERMINALIA BELLIRICA A Only for use when the preparation is as an aqueous extract of the fruit pericarp. 4863 TERMINALIA CATAPPA A, H 4864 TERMINALIA CHEBULA A, H 4865 TERMINALIA FERDINANDIANA A, E, H When used as an active ingredient: (a) the plant part must be from fruit flesh or seed only; and (b) the plant preparation must be limited to fresh, dry, powder, and extraction preparations with water as the only solvent. When used as an excipient ingredient: (a) the route of administration for medicines that contain Terminalia ferdinandiana must be limited to topical for dermal use; (b) medicines that contain Terminalia ferdinandiana are not to be intended for use on damaged skin or in the eye; and (c) the concentration of Terminalia ferdinandiana in the medicine must not be more than 0.3%. 4866 TERMINALIA SERICEA E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. Only for use when the plant part is root bark. Only methanol/water (90:10; V/V) extract of Terminalia sericea bark of the root is approved. The concentration in the medicine must be no more than 0.1%. 4867 TERPENE RESIN E Terpene resin must only be included in medicines when in combination with other permitted ingredients as a proprietary excipient formulation in medicines with a dermal route of administration for topical application. 4868 TERPINEN-4-OL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4869 TERPINEOL E 4870 TERPINEOL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4871 TERPINOLENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4872 TERPINYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4873 TERPINYL BUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. 4874 TERPINYL METHYL ETHER E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4875 TERT-BUTYL ALCOHOL E Only for use in topical medicines for dermal application. 4876 TERT-BUTYL HYDROQUINONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4877 TERT-BUTYL METHYL ETHER E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4878 TERT-BUTYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4879 TETRACLINIS ARTICULATA A, E, H 4880 TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.002%. 4881 TETRADIUM RUTICARPUM A, H When for internal use, oxedrine is a mandatory component of Tetradium ruticarpum. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 mg. 4882 TETRAHEXYLDECYL ASCORBATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. 4883 TETRAHYDRO LINALYLACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4884 TETRAHYDRO PARA-METHYLQUINOLINE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4885 TETRAHYDRO-6-(3-PENTENYL)-2H-PYRAN-2-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4886 TETRAHYDRODIFERULOYLMETHANE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 4887 TETRAHYDROFURFURYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4888 TETRAHYDROGERANYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4889 TETRAHYDROLINALOOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4890 TETRAHYDROMUGUOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4891 TETRAHYDROMYRCENOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4892 TETRAHYDROXYPROPYL ETHYLENEDIAMINE E Only for use in topical medicines for dermal application. 4893 TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4894 TETRAPANAX PAPYRIFER A, H 4895 TETRASODIUM ETIDRONATE E Only for use in topical medicines for dermal application. 4896 TETRASODIUM PYROPHOSPHATE E 4897 TEUCRIUM CHAMAEDRYS A, H The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium chamaedrys. 4898 TEUCRIUM MARUM A, H The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium marum. 4899 TEUCRIUM SCORODONIA A, H The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium scorodonia. 4900 THAPSIA GARGANICA A, H 4901 THAUMATIN E 4902 THEANINE A Only to be used in a medicine where Trans Chem Pty Ltd (Client ID 21878), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 1 March 2026. The route of administration for medicines that contain theanine must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 450 mg of theanine. The following warning statements (or words to the same effect) are required on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women'; and - (ADULT) 'Adults only'. 4903 THEASPIRANE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4904 THEMEDA TRIANDRA A, H 4905 THEOBROMA CACAO A, E, H Caffeine is a mandatory component of Theobroma cacao. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: - (ADULT) 'Adults only' (or words to that effect). - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80 mg of caffeine.' - (CAFFPREG) 'Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.' When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.' - (CAFFCYP) 'Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines' (or words to that effect). 4906 THEOBROMA OIL A, E, H 4907 THIAMINE A, E 4908 THIAMINE HYDROCHLORIDE A, E 4909 THIAMINE NITRATE A, E 4910 THIOCINEOLE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4911 THIOTAURINE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.02%. 4912 THLASPI ARVENSE A, E, H 4913 THREONINE A, E 4914 THUJA OCCIDENTALIS A, H 4915 THUJA PLICATA A, E, H 4916 THYME HERB DRY A, E, H 4917 THYME OIL A, E, H When the concentration of Thyme oil in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, a restricted flow insert must be fitted on the container and the medicine requires the warning statement: - (CHILD) 'Keep out of reach of children' (or words to that effect). 4918 THYMOL A, E When used as an active ingredient, the medicine must be medicated space spray or medicated throat lozenges. When used as an excipient, only for use in medicated throat lozenges or topical medicines for dermal applications. 4919 THYMOL METHYL ETHER E Thymol methyl ether must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of the flavour proprietary excipient formulation containing thymol methyl ether must not be more than 5% of the total medicine. 4920 THYMUS CAPITATUS A, E, H When the plant preparation is an oil, and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, a restricted flow insert must be fitted on the container and the medicine requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). 4921 THYMUS GLAND H Only for use as an active homoeopathic ingredient. 4922 THYMUS MASTICHINA A, E, H When the plant preparation is an oil, and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, a restricted flow insert must be fitted on the container and the medicine requires the following warning statement on the medicine label:- (CHILD) 'Keep out of reach of children' (or words to that effect). 4923 THYMUS SERPYLLUM A, E, H When the plant preparation is an oil, and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, a restricted flow insert must be fitted on the container and the medicine requires the following warning statement on the medicine label:- (CHILD) 'Keep out of reach of children' (or words to that effect). 4924 THYMUS VULGARIS A, E, H When the plant preparation is oil or distillate, and the concentration of Thymus vulgaris oil or distillate in the preparation is greater than 50%: (a) the nominal capacity of the container must not be more than 25 millilitres; (b) a restricted flow insert must be fitted on the container; and (c) the following warning statement is required on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). 4925 THYMUS VULGARIS MIS A, E, H When the plant preparation is an oil or distillate, and the concentration of Thymus vulgaris MIS oil or distillate in the preparation is greater than 50%: (a) the nominal capacity of the container must not be more than 25 millilitres; (b) a restricted flow insert must be fitted on the container; and (c) the following warning statement is required on the label: - (CHILD) 'Keep out of reach of children' (or words to that effect). 4926 THYMUS ZYGIS A, H When the plant preparation is an oil or a distillate, and the concentration of Thymus zygis oil or distillate in the preparation is greater than 50%: (a) the nominal capacity of the container must not be more than 25 millilitres; (b) a restricted flow insert must be fitted on the container; and (c) the following warning statement is required on the label: - (CHILD) 'Keep out of reach of children' (or words to that effect). 4927 TIGER SNAKE H Only for use as an active homoeopathic ingredient. 4928 TILACTASE A Must be derived from Aspergillus oryzae and comply with the relevant USP monograph. 4929 TILIA CORDATA A, E, H 4930 TILIA PLATYPHYLLOS A, E, H 4931 TILIA TOMENTOSA A, H 4932 TILIA X VULGARIS A, E, H 4933 TILIANTOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4934 TIN H Only for use as an active homoeopathic ingredient. 4935 TINOSPORA CORDIFOLIA A, H 4936 TINOSPORA SINENSIS A, H 4937 TITANIUM DIOXIDE A, E For use as an active ingredient only in sunscreens for dermal application. The concentration in sunscreens must be no more than 25%. For use as an excipient only as a colour and only in medicines limited to oral and topical routes of administration. Not to be included in medicines intended for use in the eye. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 4938 TOCOCYSTEAMIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.01%. 4939 TOCOFERSOLAN E Only for oral and topical use. When for oral use, the concentration in the medicine must be no more than 10% w/w. When used in topical medicines for dermal application, it is not to be included in medicines intended for use in the eye. When for topical use, the concentration in the medicine must be no more than 0.1% 4940 TOCOPHEROL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4941 TOCOPHERYL GLUCOSIDE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin or in the eye. The concentration in the medicine must be no more than 0.05% 4942 TOCOPHERYL LINOLEATE E Only for use in topical medicines for dermal application. 4943 TOCOPHERYL NICOTINATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration must not exceed 0.3%. 4944 TOLU BALSAM A, E, H 4945 TOLUENE E The residual solvent limit for toluene is 8.9 mg per maximum recommended daily dose. The concentration in the medicine must be no more than 0.089%. 4946 TOLYL ALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4947 TOLYLALDEHYDE GLYCERYLACETAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4948 TOMATO E 4949 TONKA E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4950 TONKA BEAN EXTRACT E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4951 TONONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4952 TOXICODENDRON DIVERSILOBUM H Only for use as an active homoeopathic ingredient. 4953 TOXICODENDRON PUBESCENS H Only for use as an active homoeopathic ingredient. The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Toxicodendron pubescens. 4954 TOXICODENDRON RADICANS A, H The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Toxicodendron radicans. 4955 TOXICODENDRON SUCCEDANEUM H Only for use as an active homoeopathic ingredient. 4956 TRACHELOSPERMUM JASMINOIDES A, E, H 4957 TRACHYSPERMUM AMMI A, E Only for use in oral medicines when the plant part is fruit or seed. The medicine requires the following warning statements on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect) - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect). Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4958 TRAGACANTH A, E 4959 TRAMETES VERSICOLOR A, H 4960 TRAMETES VERSICOLOR PROTEOGLYCAN CONCENTRATE A, H Only for use in oral medicines. 4961 TRANS,TRANS-2,4-DECADIEN-1-AL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4962 TRANS,TRANS-2,4-HEXADIENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in the medicine must be no more than 1%. The maximum daily dose must provide no more than 13.5 mg of Trans,Trans-2,4-Hexadienal. 4963 TRANS-1-(2,4,4-TRIMETHYL-2-CYCLOHEXEN-1-YL)-2-BUTEN-1-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4964 TRANS-2-DECENAL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4965 TRANS-2-DODECENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4966 TRANS-2-HEPTEN-1-AL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4967 TRANS-2-HEXENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4968 TRANS-2-HEXENOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4969 TRANS-2-HEXENOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 4970 TRANS-2-HEXENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4971 TRANS-2-HEXENYL PHENYLACETATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4972 TRANS-2-HYDROXYCINNAMIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4973 TRANS-2-OCTENAL E trans-2-Octenal must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing trans-2-octenal must not be more than 1% of the total medicine. 4974 TRANS-2-UNDECENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4975 TRANS-3-HEXENOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4976 TRANS-4-DECENAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4977 TRANS-8-(1-METHYLETHYL)-1-OXASPIRO(4.5)DECAN-2-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4978 TRANS-ETHYL 2-OCTENOATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4979 TRANS-METHYL-2-HEXENOATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 4980 TREACLE E When for oral or sublingual use, sucrose is a mandatory component of treacle. 4981 TREEMOSS ABSOLUTE E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. When included in a medicine for use on the lips the concentration of treemoss absolute must be no more than 0.02%. When for dermal use or use on the hair the concentration of treemoss absolute must be no more than 0.1% The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 4982 TREFRIW WELLS MINERAL WATER A When for internal use, iron is a mandatory component of Trefriw Wells mineral water. Solid dosage forms containing more than 5 milligrams of elemental iron in each dosage unit are required to have a child resistant closure. Liquid Preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure. Only able to be used when presented in single use sachets for therapeutic use as an iron supplement. 4983 TREHALOSE DIHYDRATE E When for oral use and the quantity of trehalose dihydrate per maximum recommended daily dose exceeds 20 grams, the quantity of trehalose dihydrate must be declared on the label. 4984 TREMELLA FUCIFORMIS A, H 4985 TRIACETIN E 4986 TRIACONTANYL PVP E Only for use in topical medicines for dermal application. 4987 TRIADICA SEBIFERA A, H 4988 TRIBASIC POTASSIUM PHOSPHATE A, E, H When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of tribasic potassium phosphate. When used in a solid medicine containing this ingredient, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid medicine containing this ingredient, the pH of the medicine must be no more than 11.5. 4989 TRIBASIC SODIUM PHOSPHATE E When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. 4990 TRIBEHENIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 6%. 4991 TRIBEHENIN PEG-20 ESTERS E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 6%. 4992 TRIBULUS TERRESTRIS A, E, H 4993 TRIBUTYL ACETYLCITRATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4994 TRICALCIUM PHOSPHATE E 4995 TRICAPRYLIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 4996 TRICAPRYLYL CITRATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 7%. 4997 TRICETEARETH-4 PHOSPHATE E Only for use in topical medicines for dermal application. 4998 TRICHLOROMETHYLPHENYLCARBINYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 4999 TRICHODERMA VIRIDE A, E, H 5000 TRICHOSANTHES KIRILOWII A, E, H 5001 TRICLOSAN E The concentration in the medicine must be no more than 1%. 5002 TRICYCLODECENYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 5003 TRIDECANAL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 5004 TRIDECETH-4 PHOSPHATE E Only for use in topical medicines for dermal application. 5005 TRIDECETH-6 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.5%. 5006 TRIDECYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used as in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 5007 TRIDECYL BEHENATE E Behenic acid is a mandatory component of Tridecyl behenate. Only for use in topical medicines for dermal application. 5008 TRIDECYL NEOPENTANOATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 23%. 5009 TRIDECYL SALICYLATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 5010 TRIDECYL STEARATE E Only for use in topical medicines for dermal application. 5011 TRIDECYL TRIMELLITATE E Only for use in topical medicines for dermal application. 5012 TRIETHOXYCAPRYLYLSILANE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 1%. 5013 TRIETHYL CITRATE E 5014 TRIETHYLENE GLYCOL E 5015 TRIFOLIUM PRATENSE A, E, H 5016 TRIFOLIUM REPENS A, H 5017 TRIGONELLA FOENUM-GRAECUM A, E, H 5018 TRIHYDROXYPALMITAMIDOHYDROXYPROPYL MYRISTYL ETHER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.02%. 5019 TRIHYDROXYSTEARIN E Only for use in topical medicines for dermal application. 5020 TRIISOCETYL CITRATE E Only for use in topical medicines for dermal application. 5021 TRIISODECYL TRIMELLITATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 5022 TRIISONONANOIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 5023 TRIISOSTEARIN E Only for use in topical medicines for dermal application. 5024 TRILAURIN E Only for use in topical medicines for dermal application. 5025 TRILISA ODORATISSIMA A, H 5026 TRILLIUM ERECTUM A, H 5027 TRIMETHOXYCAPRYLYL SILANE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.25%. 5028 TRIMETHYL HYDROXYPENTYL ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 5029 TRIMETHYL UNDECYLENIC ALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 5030 TRIMETHYL-BICYCLO-HEPTANE-SPIROCYCLOHEXENONE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 5031 TRIMETHYLBENZENEPROPANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 5032 TRIMETHYLHEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 5033 TRIMETHYLOPROPANE TRIOCTANOATE E Only for use in topical medicines for dermal application. 5034 TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 5035 TRIMETHYLSILOXYSILICATE E Only for use in topical medicines for dermal application. 5036 TRINITROPHENOL H Only for use as an active homoeopathic ingredient. The total concentration of trinitrophenol in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 5037 TRIOCTANOIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 5038 TRIOCTYLDODECYL CITRATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 12%. 5039 TRIOLEIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 5040 TRIOSTEUM PERFOLIATUM A, H 5041 TRIOXAUNDECANEDIOIC ACID E 5042 TRIPEPTIDE-1 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.002%. 5043 TRIS-BIPHENYL TRIAZINE A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used topically, the dosage form must not be spray. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 5044 TRISILOXANE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 40%. 5045 TRISODIUM EDETATE E Only for use in topical medicines for dermal application. 5046 TRISODIUM ETHYLENEDIAMINE DISUCCINATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. 5047 TRISODIUM NTA E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.005%. 5048 TRISTEARIN E 5049 TRITICUM AESTIVUM A, E, H Gluten is a mandatory component when the plant part is seed and the route of administration is other than topical and mucosal. 5050 TRITICUM DURUM A, E, H Gluten is a mandatory component when the plant part is seed and the route of administration is other than topical and mucosal. 5051 TRIUNDECANOIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 11.2%. 5052 TROLAMINE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%. 5053 TROLAMINE LAURIL SULFATE E Only for use in topical medicines for dermal application. 5054 TROLAMINE SALICYLATE A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 12%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 5055 TROLLIUS CHINENSIS A, H 5056 TROMETAMOL E 5057 TROMETAMOL HYDROCHLORIDE E 5058 TROPAEOLUM MAJUS A, E, H 5059 TROPICAL RATTLESNAKE H Only for use as an active homoeopathic ingredient. 5060 TROPOLONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.01%. 5061 TSUGA CANADENSIS A, H 5062 TULIPA EDULIS A, H Colchicine is a mandatory component of Tulipa edulis. The concentration of colchicine in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%. 5063 TURMERIC E Permitted for use only in combination with other permitted ingredients as a colour. 5064 TURNERA DIFFUSA A, E, H Beta-arbutin is a mandatory component of Turnera diffusa. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 5065 TURNIP E 5066 TURPENTINE OIL A, E Only permitted for use when turpentine oil is derived from sources other than mineral turpentine. The concentration in the medicine must not be more than 25%. 5067 TYPHA ANGUSTIFOLIA A, H 5068 TYPHA LATIFOLIA A, H 5069 TYPHONIUM GIGANTEUM A, H 5070 TYROSINE A, E Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine Note: See sections 5 and 6. Permissible ingredients and requirements Column 1 Column 2 Column 3 Column 4 Item Ingredient name Purpose Specific requirements 5071 UBIDECARENONE A, E When used as an excipient, the route of administration must be topical and the concentration in the medicine must not be more than 0.05%. Not to be included in medicines intended for use in the eye. When for internal use, the maximum recommended daily dose must not provide more than 300 milligrams of ubidecarenone. When for internal use in combination with Ubiquinol-10, the maximum recommended daily dose must not provide more than 300 milligrams of ubiquinol-10 and ubidecarenone combined. When for internal use, the following warning statement is required on the medicine label: - (WARF) 'Do not take while on warfarin therapy without medical advice'. 5072 UBIQUINOL-10 A, E When used as an excipient, the route of administration must be topical and the concentration in the medicine must be no more than 0.05%. Not to be included in medicines intended for use in the eye. When for internal use, the maximum recommended daily dose must provide no more than 300 milligrams of ubiquinol-10. When used in combination with ubidecarenone, the maximum recommended daily dose must provide no more than 300 mg of ubiquinol-10 and ubidecarenone combined. The medicine requires the following warning statement on the medicine label: - (WARF) 'Do not take while on warfarin therapy without medical advice.' 5073 ULEX EUROPAEUS A, H 5074 ULMUS AMERICANA A, H 5075 ULMUS CAMPESTRIS A, H 5076 ULMUS GLABRA A, H 5077 ULMUS MINOR A, H 5078 ULMUS PARVIFOLIA A, H 5079 ULMUS PUMILA A, H 5080 ULMUS RUBRA A, H 5081 ULTRALIDE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 5082 ULTRAMARINE BLUE E Permitted for use only as a colour for topical use. 5083 ULVA LACTUCA A, H Iodine is a mandatory component of Ulva lactuca. Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 5084 UMBELLULARIA CALIFORNICA A, H 5085 UNCARIA GAMBIR A, H 5086 UNCARIA RHYNCOPHYLLA A, H 5087 UNCARIA SINENSIS A, H 5088 UNCARIA TOMENTOSA A, H 5089 UNDARIA PINNATIFIDA A, H Whole dried Undaria pinnatifida must not contain the holdfast. Only for use in oral medicines. 5090 UNDECANAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 5091 UNDECANOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. 5092 UNDECENOIC ACID E 5093 UNDECYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 5094 UNDECYLCRYLENE DIMETICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. 5095 UNDECYLENAMIDE DEA E 5096 UNDECYLENOYL PEG-5 PARABEN E Only for use in topical medicines for dermal application. 5097 URANIUM NITRATE H Only for use as an active homoeopathic ingredient. 5098 UREA A, E, H Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 10% (w/w). 5099 URTICA DIOICA A, E, H 5100 URTICA URENS A, H 5101 USNEA BARBATA A, H 5102 UVA URSI LEAF DRY A, H 5103 UVA URSI LEAF POWDER A, E, H 5104 VA/BUTYL MALEATE/ISOBORNYL ACRYLATE COPOLYMER E Vinyl acetate is a mandatory component of VA/butyl maleate/isobornyl acrylate copolymer. The concentration of vinyl acetate in the medicine must be no more than 0.01% or 100 ppm. Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. 5105 VACCARIA SEGATALIS A, H 5106 VACCINIUM BRACTEATUM A, H 5107 VACCINIUM CORYMBOSUM E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 5108 VACCINIUM MACROCARPON A, E, H 5109 VACCINIUM MYRTILLOIDES A, H 5110 VACCINIUM MYRTILLUS A, E, H 5111 VACCINIUM OXYCOCCUS A, H 5112 VACCINIUM VITIS-IDAEA A, H Beta-arbutin is a mandatory component of Vaccinium vitis-idaea. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 5113 VALENCENE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 5114 VALERALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 5115 VALERIAN DRY A, H The following warning statement is required on the medicine label when the medicine is for oral use: (VALER) 'In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.' 5116 VALERIAN OIL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 5117 VALERIAN POWDER A, H The following warning statement is required on the medicine label when the medicine is for oral use: (VALER) 'In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.' 5118 VALERIANA EDULIS A, H 5119 VALERIANA OFFICINALIS A, H The following warning statement is required on the medicine label when the medicine is for oral use: (VALER) 'In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.' 5120 VALERIANA SORBIFOLIA A, H 5121 VALERIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 5122 VALINE A, E 5123 VANADIUM H 5124 VANILLA E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 5125 VANILLA DRY A, E, H 5126 VANILLA EXTRACT E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 5127 VANILLA OLEORESIN E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 5128 VANILLA PLANIFOLIA A, E, H 5129 VANILLA POWDER A, E, H 5130 VANILLA TAHITENSIS A, H 5131 VANILLIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 5132 VANILLIN E 5133 VANILLIN ACETATE E Vanillin acetate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing vanillin acetate must not be more than 5% of the total medicine. The maximum recommended daily dose of the medicine must not provide more than 1.8 micrograms of vanillin acetate. 5134 VANILLIN ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 5135 VANILLYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 5136 VAT RED 1 E Permitted for use only as a colour for topical use. 5137 VAT RED 1 ALUMINIUM LAKE E Permitted for use only as a colour for topical use. 5138 VAT RED 5 E Permitted for use only as a colour for topical use. 5139 VEGETABLE OIL E 5140 VEGETABLE OIL PHYTOSTEROL ESTERS A Only for use in oral medicines. The medicine requires the following warning statement on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women (or words to that effect).' 5141 VEIN H Only for use as an active homoeopathic ingredient. 5142 VERATRALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 5143 VERATROL E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 5144 VERATRUM ALBUM A, H Solanidine is a mandatory component of Veratrum album. The concentration of equivalent dry Veratrum album in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%. 5145 VERBASCUM DENSIFLORUM A, H 5146 VERBASCUM THAPSUS A, H 5147 VERBENA OFFICINALIS A, H 5148 VERBENA OIL E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 5149 VERONICA CHAMAEDRYS A, H 5150 VERONICA OFFICINALIS A, H 5151 VERONICASTRUM VIRGINICUM A, E, H 5152 VERTONAL E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. When included in a medicine for use on the lips the concentration of vertonal must be no more than 0.2%. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. 5153 VETIVER OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 5154 VETIVERYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 5155 VIBURNUM OPULUS A, E, H 5156 VIBURNUM PRUNIFOLIUM A, E, H 5157 VICIA FABA A, H Levodopa is a mandatory component of Vicia faba. The concentration of levodopa in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%. 5158 VIGNA ANGULARIS VAR. ANGULARIS A, H 5159 VIGNA RADIATA A, H 5160 VIGNA UMBELLATA A, H 5161 VINCA MAJOR A, H Vincamine is a mandatory component of Vinca major. The concentration of vincamine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%. 5162 VINCA MINOR A, H Vincamine and vincristine are mandatory components of Vinca minor. The concentration of vincamine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%. The concentration of Vincristine in the medicine must be no more than 10mg/kg or 10mg/L or 0.001% 5163 VINCETOXICUM OFFICINALE A, H 5164 VINEGAR E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 5165 VIOLA ODORATA A, E, H 5166 VIOLA TRICOLOR A, H 5167 VIOLA YEDOENSIS A, H 5168 VIOLET LEAF ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. 5169 VIPER H Only for use as an active homoeopathic ingredient. 5170 VISCUM ALBUM A, E, H 5171 VISCUM COLORATUM A, H 5172 VISCUM FLAVESCENS A, H 5173 VITELLARIA PARADOXA A, E, H 5174 VITEX AGNUS-CASTUS A, E, H When the ingredient is in a medicine that is for internal use, the following warning statement is required on the label: - (VAC) 'Vitex agnus-castus may affect hormones and medicines such as oral contraceptives. Consult your health professional before use' (or words to that effect). 5175 VITEX NEGUNDO A, H 5176 VITEX ROTUNDIFOLIA A, H 5177 VITEX TRIFOLIA A, H 5178 VITIS VINIFERA A, E, H 5179 VITREOSCILLA CONCENTRATE E Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%. 5180 VP/ACRYLATES/LAURYL METHACRYLATE COPOLYMER E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must not be more than 2.00%. 5181 WAHLENBERGIA GRACILIS A, H 5182 WALNUT E 5183 WALNUT OIL E 5184 WHEAT E Gluten is a mandatory component of Wheat when the route of administration is other than topical and mucosal. 5185 WHEAT BRAN E Gluten is a mandatory component of Wheat bran when the route of administration is other than topical and mucosal. 5186 WHEAT DEXTRIN A, E Gluten is a mandatory component of wheat dextrin. Only for use when the dosage form is capsule, tablet or pill. 5187 WHEAT GERM E Gluten is a mandatory component of Wheat germ when the route of administration is other than topical and mucosal. 5188 WHEAT GERM GLYCERIDES E Gluten is a mandatory component of wheat germ glycerides when the route of administration is other than topical and mucosal. 5189 WHEAT LEAF E 5190 WHEAT STARCH E When the route of administration is other than topical or mucosal, gluten is a mandatory component of wheat starch. 5191 WHEATGERM OIL A, E, H 5192 WHEY POWDER E Lactose is a mandatory component of Whey powder when the route of administration is oral. 5193 WHEY PROTEIN E Lactose is a mandatory component of Whey protein when the route of administration is oral. 5194 WHEY PROTEIN CONCENTRATE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 5195 WHITE BEESWAX E 5196 WHITE HOREHOUND HERB DRY A, H 5197 WHITE HOREHOUND HERB POWDER A, H 5198 WHITE SOFT PARAFFIN A, E When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 5199 WHOLE DRY MILK E 5200 WIKSTROEMIA VIRIDIFLORA A, H 5201 WILD CARROT HERB DRY A, E, H 5202 WILD CARROT HERB POWDER A, H 5203 WILD CHERRY BARK DRY A, H 5204 WILD CHERRY BARK POWDER A, H 5205 WILD LETTUCE LEAF DRY A, H 5206 WILD LETTUCE LEAF POWDER A, H 5207 WINTERGREEN OIL A, E, H Methyl salicylate is a mandatory component of wintergreen oil. Not to be included in medicines for use in the eye or on damaged skin. When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging. When the concentration of methyl salicylate in a liquid preparation is more than 5%, and the dosage form is spray, the medicine does not require child resistant packaging if: - the delivery device is engaged into the container in such a way that prevents it from being readily removed; - direct suction through the delivery device results in delivery of no more than one dosage unit; and - actuation of the spray device is ergonomically difficult for young children to accomplish. The following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect). When for use in topical medicines for dermal application: i) the concentration of methyl salicylate in the medicine must not be more than 25%; ii) the following warning statements are required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less'; - (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect); - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect); iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label: - (IRRIT) 'If irritation develops, discontinue use'. 5208 WITHANIA SOMNIFERA A, E, H The medicine requires the following warning statement on the label: - (WITHANIA) 'If you are pregnant, or considering becoming pregnant, do not take without consulting a health professional' (or words to that effect) unless: (a) the plant part is root; (b) the plant preparation is an extract; (c) the extraction solvents are only water, ethanol or methanol; and (d) the maximum recommended daily dose of the medicine contains no more than the equivalent quantity of 12 g dry root. 5209 WOLFIPORIA COCOS A, E, H 5210 WOOL ALCOHOLS E Only for use in topical medicines for dermal application. 5211 WOOL FAT A, E When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 5212 XANTHAN GUM E 5213 XANTHIUM SIBIRICUM A, H The requirements specified in paragraphs (a) to (h) below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. (a) Carboxyatractyloside and atractyloside are mandatory components of Xanthium sibiricum. (b) The concentration of carboxyatractyloside must not be more than 0.35% of Xanthium sibiricum. (c) The concentration of atractyloside must not be more than 0.3% of Xanthium sibiricum. (d) The route of administration for medicines that contain Xanthium sibiricum must be limited to oral. (e) The plant part must be limited to fruit that is dried, cooked and had the spines removed. (f) The plant preparation must be limited to dry, powder, and extraction preparations with water as the only solvent. (g) The maximum recommended daily dose of the medicine must not provide more than 10 g of Xanthium sibiricum. (h) The medicine must not be directed for use in children, those who are pregnant, likely to become pregnant, or lactating. 5214 XANTHIUM STRUMARIUM A, H The requirements specified in paragraphs (a) to (h) below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. (a) Carboxyatractyloside and atractyloside are mandatory components of Xanthium strumarium. (b) The concentration of carboxyatractyloside must not be more than 0.35% of Xanthium strumarium. (c) The concentration of atractyloside must not be more than 0.3% of Xanthium strumarium. (d) The route of administration for medicines that contain Xanthium strumarium must be limited to oral. (e) The plant part must be limited to fruit that is dried, cooked and had the spines removed. (f) The plant preparation must be limited to dry, powder, and extraction preparations with water as the only solvent. (g) The maximum recommended daily dose of the medicine must not provide more than 10 g of Xanthium strumarium. (h) The medicine must not be directed for use in children, those who are pregnant, likely to become pregnant, or lactating. 5215 XANTHOMONA CAMPESTRIS A, H 5216 XEROPHYLLUM ASPHODELOIDES A, H 5217 XYLENE E The residual solvent limit for xylene is 21.7 mg per maximum recommended daily dose. The concentration in the medicine must be no more than 0.217%. 5218 XYLITOL E 5219 XYLOSE E 5220 YAM E 5221 YARROW HERB DRY A, H 5222 YARROW HERB POWDER A, H 5223 YEAST AUTOLYSATE E 5224 YEAST DRIED A, E, H 5225 YELLOW 2G E Permitted for use only as a colour for topical use. 5226 YELLOW BEESWAX E 5227 YELLOW MERCURIC OXIDE H Only for use as an active homoeopathic ingredient. 5228 YELLOW SOFT PARAFFIN A, E Only for use in topical medicines for dermal application. When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. 5229 YLANG YLANG OIL A, E, H 5230 YUCCA BACCATA A, H 5231 YUCCA ELATA A, H 5232 YUCCA FILAMENTOSA A, H 5233 YUCCA GLORIOSA A, H 5234 Z-BETA-DAMASCONE E Z – beta damascone must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing Z – beta damascone must not be more than 5% of the total medicine. 5235 ZANTHOXYLUM AMERICANUM A, H 5236 ZANTHOXYLUM BUNGEANUM A, E, H 5237 ZANTHOXYLUM CLAVA-HERCULIS A, H 5238 ZANTHOXYLUM NITIDUM A, H 5239 ZANTHOXYLUM PIPERITUM A, H 5240 ZANTHOXYLUM SIMULANS A, H 5241 ZEA MAYS A, E, H 5242 ZEAXANTHIN A, E 5243 ZEIN E 5244 ZINC H Only for use as an active homoeopathic ingredient. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'. 5245 ZINC AMINO ACID CHELATE A, E, H When used internally, zinc is a mandatory component of zinc amino acid chelate. The concentration of zinc in zinc amino acid chelate must be no more than 30%. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5246 ZINC ASCORBATE A, E, H When used internally, zinc is a mandatory component of zinc ascorbate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5247 ZINC ASCORBATE MONOHYDRATE A, E, H When used internally, zinc is a mandatory component of zinc ascorbate monohydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'. 5248 ZINC CHLORIDE A, E, H The concentration of zinc chloride in the medicine must be no more than 5%. When used internally, zinc is a mandatory component of zinc chloride. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5249 ZINC CITRATE A, E, H When used internally, zinc is a mandatory component of zinc citrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5250 ZINC CITRATE DIHYDRATE A, E, H When used internally, zinc is a mandatory component of zinc citrate dihydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5251 ZINC CITRATE TRIHYDRATE A, E, H When used internally, zinc is a mandatory component of zinc citrate trihydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5252 ZINC DIASPARTATE A When used internally, zinc is a mandatory component of zinc diaspartate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5253 ZINC GLUCONATE A, E, H When used internally, zinc is a mandatory component of zinc gluconate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5254 ZINC GLYCINATE A When used internally, zinc is a mandatory component of Zinc glycinate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5255 ZINC GLYCINATE MONOHYDRATE A When used internally, zinc is a mandatory component of Zinc glycinate monohydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'. 5256 ZINC LACTATE E Only for use in topical and dental medicines and not to be included in medicines intended for use in the eye. The concentration of zinc lactate in a medicine intended for topical use should not be more than 2%. The concentration of zinc lactate in a medicine for 'dental' use in toothpaste medicines must not be more than 2.5%. Zinc lactate is not to be included in dental/toothpaste medicines intended for use by children less than 12 years old. Medicines containing zinc lactate for dental use require the following warning statement (or words to the same effect) on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'. 5257 ZINC LACTATE DIHYDRATE E Only for use in topical and dental medicines and not to be included in medicines intended for use in the eye. The concentration of zinc lactate dihydrate in a medicine intended for topical use should not be more than 2%. The concentration of zinc lactate dihydrate in a medicine for 'dental' use in toothpaste medicines must not be more than 2.5%. Zinc lactate dihydrate is not to be included in dental/toothpaste medicines intended for use by children less than 12 years old. Medicines containing zinc lactate dihydrate for dental use require the following warning statement (or words to the same effect) on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'. 5258 ZINC LYSINATE A When used internally, zinc is a mandatory component of Zinc lysinate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5259 ZINC METHIONINE SULFATE A For topical use, the concentration of zinc methionine sulfate must be no more than 5%. When used internally, zinc is a mandatory component of zinc methionine sulfate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5260 ZINC MYRISTATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. 5261 ZINC OXIDE A, E, H When used internally, zinc is a mandatory component of zinc oxide. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR -'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period' (or words to that effect). When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). 5262 ZINC PARA-PHENOLSULFONATE E Only permitted for use in topical medicines for dermal use. The concentration of zinc para-phenolsulfonate in the medicine must not exceed 5%. 5263 ZINC STEARATE E When used internally, zinc is a mandatory component of zinc stearate. The percentage of zinc from zinc stearate should be calculated based on the molecular weight of zinc stearate. When for internal use, the maximum recommended daily dose must not provide more than 50 milligrams of zinc. When for internal use and the maximum recommended daily dose is more than 25 milligrams but not more than 50 milligrams of zinc, the medicine requires the following warning statement (or words to the same effect) on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period'; or 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period'. 5264 ZINC SUCCINATE A, E, H When used internally, zinc is a mandatory component of zinc succinate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' or - 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5265 ZINC SULFATE A, E For topical use, the concentration of zinc sulfate must be no more than 5%. For internal use, zinc is a mandatory component of zinc sulfate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR - 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5266 ZINC SULFATE HEPTAHYDRATE A, E For topical use, the concentration of zinc sulfate must be no more than 5%. For internal use, zinc is a mandatory component of zinc sulfate heptahydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR - 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5267 ZINC SULFATE HEXAHYDRATE A, E, H For topical use, the concentration of zinc sulfate must be no more than 5%. For internal use, zinc is a mandatory component of zinc sulfate hexahydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR - 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5268 ZINC SULFATE MONOHYDRATE A, E, H When the route of administration is topical the concentration of zinc sulfate in the medicine must be no more than 5%. When the medicine is for internal use, zinc is a mandatory component of zinc sulfate monohydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR - 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' 5269 ZINC VALERATE H Only for use as an active homoeopathic ingredient. When for internal use, zinc is a mandatory component of zinc valerate. The percentage of zinc from zinc valerate should be calculated based on the molecular weight of zinc valerate. When for internal use, the maximum recommended daily dose must not provide more than 50 milligrams of zinc. When for internal use and the maximum recommended daily dose is more than 25 milligrams but not more than 50 milligrams of zinc, the medicine requires the following warning statement (or words to the same effect) on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period'; or 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period'. 5270 ZINGERONE E Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. 5271 ZINGIBER OFFICINALE A, E, H When for oral use AND the extract ratio is equal to or more than 25:1 AND the equivalent dry weight per dosage unit is equal to or more than 2g, the medicine requires the following warning statement on the medicine label: - (GINGER) 'Individuals taking anticoagulants should seek medical advice before taking this medicine.' AND 'Individuals at risk of bleeding problems should seek advice from their healthcare practitioner prior to taking this medicine'. 5272 ZIZIPHUS JUJUBA A, H 5273 ZIZIPHUS JUJUBA VAR. SPINOSA A, H 5274 ZIZYPHUS SATIVA A, H 5275 ZOSTERA MARINA A, H