Federal Register of Legislation - Australian Government

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Determinations/Health as made
This instrument repeals and replaces the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2021 and specifies those ingredients that may be contained in a medicine that may be listed in the Australian Register of Therapeutic Goods under section 26A or 26AE of the Therapeutic Goods Act 1989, and requirements in relation to the inclusion of those ingredients in such medicines.
Administered by: Health
Registered 13 Aug 2021
Tabling HistoryDate
Tabled HR23-Aug-2021
Tabled Senate23-Aug-2021
Date of repeal 25 Oct 2021
Repealed by Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2021
Table of contents.

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

2860

KADSURA COCCINEA

A, H

 

2861

KAEMPFERIA GALANGA

A, H

 

2862

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%.

 

2863

KAOLIN

E

 

2864

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.

 

2865

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.

 

2866

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%.

 

2867

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%. 

 

2868

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'.

 

2869

KIDNEY BEAN

E

 

2870

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%.

 

2871

KIWI FRUIT

E

 

2872

KNAUTIA ARVENSIS

A, H

 

2873

KOREAN GINSENG ROOT DRY

A, H

 

2874

KOREAN GINSENG ROOT POWDER

A, H

 

2875

KRAMERIA IXIENA

A, H

 

2876

KRAMERIA LAPPACEA

A, H

 

2877

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'.

 

2878

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%.

 

2879

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%.

 

2880

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%.

 

2881

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.

 

2882

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%.

 

2883

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%.

 

2884

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%.

 

2885

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%.

 

2886

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%.

 

2887

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%.

 

2888

LABDANUM OIL

A, E, H

 

2889

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%.

 

2890

LACTALBUMIN

E

 

2891

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.

 

2892

LACTITOL

E

 

2893

LACTITOL MONOHYDRATE

E

 

2894

LACTO-N-NEOTETRAOSE

A

Only to be used in a medicine where Glycom A/S (Client ID 76983), 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 20 August 2023.

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).

 

2895

LACTOBACILLUS ACIDOPHILUS

A

 

2896

LACTOBACILLUS AMYLOVORUS

A

 

2897

LACTOBACILLUS BREVIS

A

 

2898

LACTOBACILLUS CASEI

A

 

2899

LACTOBACILLUS CASEI SUBSP. BIOVAR CASEI

A

 

2900

LACTOBACILLUS CRISPATUS

A

 

2901

LACTOBACILLUS DELBRUECKII SSP BULGARICUS

A

 

2902

LACTOBACILLUS DELBRUECKII SSP LACTIS

A

 

2903

LACTOBACILLUS FERMENTUM

A

 

2904

LACTOBACILLUS GALLINARUM

A

 

2905

LACTOBACILLUS GASSERI

A

 

2906

LACTOBACILLUS HELVETICUS

A

 

2907

LACTOBACILLUS JOHNSONII

A

 

2908

LACTOBACILLUS KEFIRANOFACIENS

A

 

2909

LACTOBACILLUS KEFIRGRANUM

A

 

2910

LACTOBACILLUS KEFIRI

A

 

2911

LACTOBACILLUS PARACASEI

A

 

2912

LACTOBACILLUS PARACASEI SUBSP. PARACASEI

A

 

2913

LACTOBACILLUS PLANTARUM

A

 

2914

LACTOBACILLUS REUTERI

A

 

2915

LACTOBACILLUS RHAMNOSUS

A

 

2916

LACTOBACILLUS SALIVARIUS SSP SALICINIUS

A

 

2917

LACTOBACILLUS SALIVARIUS SSP SALIVARIUS

A

 

2918

LACTOBIONIC ACID

E

Only for use in topical medicines for dermal application.

 

2919

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%.

 

2920

LACTOSE

E

 

2921

LACTOSE MONOHYDRATE

E

 

2922

LACTUCA SATIVA

A, H

 

2923

LACTUCA VIROSA

A, H

 

2924

LACTULOSE

E

 

2925

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.

 

2926

LAGENARIA VULGARIS

A, H

 

2927

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.

 

2928

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.

 

2929

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.

 

2930

LAMIUM ALBUM

A, H

 

2931

LANETH-5

E

Only for use in topical medicines for dermal application.

 

2932

LANOLIN ALCOHOL

E

Only for use in topical medicines for dermal application.

 

2933

LANOLIN OIL

E

Only for use in topical medicines for dermal application.

 

2934

LANOLIN WAX

E

Only for use in topical medicines for dermal application.

 

2935

LANTANA CAMARA

A, H

The maximum recommended daily dose must contain no more than 1mg of the equivalent dry herbal material of Lantana camara.

 

2936

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%.

 

2937

LARIX DECIDUA

A, H

 

2938

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.

 

2939

LARREA TRIDENTATA

A, H

The medicine requires the following warning statement on the medicine label:

- (CHAP) 'WARNING: Chaparral may harm the liver in some people - use only under supervision of a health care professional'.

 

2940

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.

 

2941

LAURAMINE OXIDE

E

 

2942

LAUREL LEAF OIL

A, H

 

2943

LAURETH-10

E

Only for use in topical medicines for dermal application.

 

2944

LAURETH-12

E

Only for use in topical medicines for dermal application.

 

2945

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.

 

2946

LAURETH-23

E

Only for use in topical medicines for dermal application.

 

2947

LAURETH-3

E

Only for use in topical medicines for dermal application.

 

2948

LAURETH-4

E

Only for use in topical medicines for dermal application.

 

2949

LAURETH-7

E

Only for use in topical medicines for dermal application.

 

2950

LAURETH-8

E

 

2951

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.

 

2952

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%.

 

2953

LAUROMACROGOL 400

E

Only for use in topical medicines for dermal application.

 

2954

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%.

 

2955

LAURUS NOBILIS

A, E, H

When the plant preparation is oil or distillate, the nominal capacity of the container must be no more than 25 millilitres.

When the concentration of Laurus nobilis oil or distillate in the preparation is greater 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.

When the concentration of Laurus nobilis oil or distillate in the preparation is greater than 25% and the nominal capacity of the container is greater than 15 millilitres, a child resistant closure must be fitted on the container.

When the concentration of Laurus nobilis oil or distillate in the preparation is greater than 25%, 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'.

 

2956

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%.

 

2957

LAURYL BETAINE

E

Only for use in topical medicines for dermal application.

 

2958

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%.

 

2959

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.

 

2960

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%.

 

2961

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%.

 

2962

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%.

 

2963

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.

 

2964

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.

 

2965

LAURYL PYRROLIDONE

E

Only for use in topical medicines for dermal application.

 

2966

LAURYLDIMONIUM HYDROXYPROPYL HYDROLYSED COLLAGEN

E

Only for use in topical medicines for dermal application.

 

2967

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%.

 

2968

LAURYLMETICONE COPOLYOL

E

Only for use in topical medicines for dermal application.

 

2969

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%.

 

2970

LAVANDIN OIL ABRIAL

A, E, H

 

2971

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%.

 

2972

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%.

 

2973

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%.

 

2974

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%.

 

2975

LAVENDER OIL

A, E, H

 

2976

LAWSONIA INERMIS

A, H

 

2977

LEAD

H

Only for use as an active homoeopathic ingredient.

The concentration in the medicine must be no more than 0.001%.

 

2978

LEAD ACETATE

H

Only for use as an active homoeopathic ingredient.

 

2979

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%.

 

2980

LECITHIN

A, E

 

2981

LEDEBOURIELLA SESELOIDES

A, H

 

2982

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.

 

2983

LEMNA MINOR

A, H

 

2984

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.

 

2985

LEMON BALM LEAF DRY

A, H

 

2986

LEMON BALM LEAF POWDER

A, E, H

 

2987

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.

 

2988

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.

 

2989

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.

 

2990

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%.

 

2991

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.

 

2992

LEMONGRASS OIL

A, E, H

 

2993

LENS CULINARIS

A, H

 

2994

LENTIL

E

 

2995

LENTINULA EDODES

A, E, H

 

2996

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%.

 

2997

LEONURUS CARDIACA

A, E, H

 

2998

LEONURUS SIBIRICUS

A, E, H

 

2999

LEPIDIUM APETALUM

A, H

 

3000

LEPIDIUM MEYENII

A

Only for use in oral medicines when the plant part is tuber and the plant preparation is dry.

The maximum recommended daily dose must be no more than 3.5g of Lepidium meyenii dried tuber (or its extract equivalent).

 

3001

LEPTOSPERMUM PETERSONII

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more 5%.

 

3002

LEPTOSPERMUM SCOPARIUM OIL

A

Only for use as an active ingredient when the route of administration is topical or oral application in a mouthwash preparation.

If the concentration is more than 25%, the nominal capacity of the container must be no more than 25mL.

When the concentration is more than 25%, and the nominal capacity of the container less than 15mL, 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)

- (NTAKEN) ‘Not to be taken’

When the concentration is more than 25%, 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 and 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’

 

3003

LESPEDEZA CAPITATA

A, H

 

3004

LETTUCE

E

 

3005

LEUCINE

A, E

 

3006

LEUZEA UNIFLORUM

A, H

 

3007

LEVISTICUM OFFICINALE

A, H

 

3008

LEVOCARNITINE

A

 

3009

LEVOCARNITINE FUMARATE

A

 

3010

LEVOCARNITINE HYDROCHLORIDE

A

 

3011

LEVOCARNITINE MAGNESIUM CITRATE

A

 

3012

LEVOCARNITINE TARTRATE

A

 

3013

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.

 

3014

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.

 

3015

LEVOTHYROXINE SODIUM

H

Only for use as an active homoeopathic ingredient.

 

3016

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%.

 

3017

LIGHT KAOLIN

E

 

3018

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.

 

3019

LIGHT MAGNESIUM OXIDE

A, E, H

The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2021; or

- released for supply after 1 March 2022. (a) Magnesium is a mandatory component of light magnesium oxide.

(b) When used in a medicine:

(i) with an oral route of administration;

(ii) not indicated for laxative (or related) use; and

(iii) where the maximum recommended daily dose for:

(A) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(C) 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).

(c) When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

3020

LIGUSTICUM SINENSE

A, H

 

3021

LIGUSTICUM STRIATUM

A, E, H

 

3022

LIGUSTRUM LUCIDUM

A, H

 

3023

LILIUM BROWNII

A, H

 

3024

LILIUM CANDIDUM

A, E, H

 

3025

LILIUM LANCIFOLIUM

A, H

 

3026

LILIUM LONGIFLORUM

A, H

 

3027

LIME FRUIT

E

 

3028

LIME 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%.

 

3029

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.

 

3030

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.

 

3031

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%.

 

3032

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%.

 

3033

LIME TREE FLOWER DRY

A, H

 

3034

LIME TREE FLOWER POWDER

A, H

 

3035

LIME, ESSENCE

E

 

3036

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%.

 

3037

LIMONENE

E

When for oral use, the quantity must be no more than 10 mg per maximum recommended daily dose.

 

3038

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%.

 

3039

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%.

 

3040

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%.

 

3041

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%.

 

3042

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%.

 

3043

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%.

 

3044

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%.

 

3045

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%.

 

3046

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%.

 

3047

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%.

 

3048

LINDERA STRYCHNIFOLIA

A, H

 

3049

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%.

 

3050

LINOLEIC ACID

E

 

3051

LINOLENIC ACID

E

 

3052

LINSEED DRY

A, E, H

 

3053

LINSEED OIL

A, E, H

 

3054

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.

 

3055

LINSEED POWDER

A, E, H

 

3056

LINUM USITATISSIMUM

A, E, H

 

3057

LIPASE

A

Lipase must only be derived from Rhizopus oryzae and must comply with the relevant compositional guideline.

 

3058

LIPPIA DULCIS

A, H

 

3059

LIQUID GLUCOSE

E

 

3060

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.

 

3061

LIQUIDAMBAR FORMOSANA

A, H

 

3062

LIQUIDAMBAR ORIENTALIS

A, H

 

3063

LIQUIDAMBAR STYRACIFLUA

A, E, H

 

3064

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%.

 

3065

LIQUIDAMBAR TAIWANIANA

A, H

 

3066

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%.

 

3067

LIQUORICE DRY

A, E, H

 

3068

LIQUORICE LIQUID EXTRACT

A, E, H

 

3069

LIQUORICE POWDER

A, E, H

 

3070

LITCHI CHINENSIS

A, H

 

3071

LITHIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

 

3072

LITHOSPERMUM OFFICINALE

A, H

The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Lithospermum officinale.

 

3073

LITSEA CUBEBA

A, E, H

 

3074

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%.

 

3075

LOBARIA PULMONARIA

A, H

 

3076

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.

 

3077

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.

 

3078

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.

 

3079

LOLIUM PERENNE

A, H

 

3080

LOLIUM TEMULENTUM

A, H

 

3081

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%.

 

3082

LONICERA CAPRIFOLIUM

A, E, H

 

3083

LONICERA JAPONICA

A, E, H

 

3084

LONICERA PERICLYMENUM

A, H

 

3085

LOPHATHERUM GRACILE

A, H

 

3086

LOQUAT

E

 

3087

LORANTHUS PARASITICUS

A, H

 

3088

LOROPETALUM CHINENSIS

A, H

 

3089

LOTUS CORNICULATUS

A, H

 

3090

LOVAGE OIL

A, E, H

 

3091

LOVAGE ROOT DRY

A, H

 

3092

LOVAGE ROOT POWDER

A, H

 

3093

LUDWIGIA PROSTRATA

A, H

 

3094

LUFFA CYLINDRICA

A, H

 

3095

LUFFA PURGANS

A, H

 

3096

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.

 

3097

LYCHEE

E

 

3098

LYCIUM BARBARUM

A, H

 

3099

LYCIUM CHINENSE

A, E, H

 

3100

LYCOPENE

A, E

 

3101

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.

 

3102

LYCOPODIUM ANNOTINUM

A, H

 

3103

LYCOPODIUM CLAVATUM

A, H

 

3104

LYCOPODIUM COMPLANATUM

A, H

 

3105

LYCOPUS EUROPAEUS

A, H

 

3106

LYCOPUS LUCIDUS

A, H

 

3107

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%.

 

3108

LYGODIUM JAPONICUM

A, H

 

3109

LYSIMACHIA CHRISTINAE

A, H

 

3110

LYSIMACHIA VULGARIS

A, H

 

3111

LYSINE

A, E

 

3112

LYSINE HYDROCHLORIDE

A, E

 

3113

LYTHRUM HYSSOPIFOLIA

A, H

 

3114

LYTHRUM SALICARIA

A, H

 

3115

LYTHRUM VERTICILLATUM

A, H

 

3116

MACADAMIA INTEGRIFOLIA

A, E

 

3117

MACADAMIA NUT

E

 

3118

MACADAMIA NUT OIL

E

 

3119

MACADAMIA TERNIFOLIA

A, E, H

 

3120

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%.

 

3121

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.

 

3122

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.

 

3123

MACROGOL 1000

E

 

3124

MACROGOL 1450

E

Only for use in topical medicines for dermal application.

 

3125

MACROGOL 1500

E

 

3126

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%.

 

3127

MACROGOL 200

E

Only for use in topical medicines for dermal application.

 

3128

MACROGOL 20000

E

 

3129

MACROGOL 300

E

 

3130

MACROGOL 3000

E

 

3131

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.

 

3132

MACROGOL 40

E

Only for use in topical medicines for dermal application.

 

3133

MACROGOL 400

E

 

3134

MACROGOL 4000

E

 

3135

MACROGOL 45000

E

Only for use in topical medicines for dermal application.

 

3136

MACROGOL 600

E

 

3137

MACROGOL 6000

E

 

3138

MACROGOL 600000

E

 

3139

MACROGOL 800

E

 

3140

MACROGOL 8000

E

 

3141

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%.

 

3142

MACROGOL POLY(VINYL ALCOHOL) GRAFTED POLYMER

E

Only for use in oral medicines.

The concentration in the medicine must be no more than 5%.

 

3143

MACROPIPER EXCELSUM VAR EXCELSUM

A, H

 

3144

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.

 

3145

MAGNESIUM ASCORBATE

A, E, H

 

3146

MAGNESIUM ASCORBATE MONOHYDRATE

A, E, H

 

3147

MAGNESIUM ASCORBYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

3148

MAGNESIUM ASPARTATE

A, E, H

 

3149

MAGNESIUM ASPARTATE DIHYDRATE

A, E, H

 

3150

MAGNESIUM ASPARTATE TETRAHYDRATE

A, E, H

 

3151

MAGNESIUM CARBONATE HYDRATE

A, E, H

 

3152

MAGNESIUM CHLORIDE 4.5-HYDRATE

A

The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2021; or

- released for supply after 1 March 2022.

(a) Magnesium is a mandatory component of magnesium chloride 4.5-hydrate.

(b) When used in a medicine:

(i) with an oral route of administration;

(ii) not indicated for laxative (or related) use; and

(iii) where the maximum recommended daily dose for:

(A) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(C) 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).

(c) When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

3153

MAGNESIUM CHLORIDE HEXAHYDRATE

A, E, H

The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2021; or

- released for supply after 1 March 2022.

(a) Magnesium is a mandatory component of magnesium chloride hexahydrate.

(b) When used in a medicine:

(i) with an oral route of administration;

(ii) not indicated for laxative (or related) use; and

(iii) where the maximum recommended daily dose for:

(A) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(C) 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).

(c) When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

3154

MAGNESIUM CITRATE

A, E, H

 

3155

MAGNESIUM CITRATE NONAHYDRATE

A, E, H

 

3156

MAGNESIUM CITRATE TETRADECAHYDRATE

A, E, H

 

3157

MAGNESIUM DIGLUTAMATE

A, E, H

 

3158

MAGNESIUM GLUCONATE

A, E, H

 

3159

MAGNESIUM GLYCEROPHOSPHATE

A, E, H

 

3160

MAGNESIUM GLYCINATE

A

Only for use in oral medicines.

 

3161

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.

 

3162

MAGNESIUM HYDROGEN PHOSPHATE

H

The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2021; or

- released for supply after 1 March 2022.

(a) Magnesium is a mandatory component of magnesium hydrogen phosphate.

(b) When used in a medicine:

(i) with an oral route of administration;

(ii) not indicated for laxative (or related) use; and

(iii) where the maximum recommended daily dose for:

(A) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(C) 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).

(c) When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

3163

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.

The requirements specified in paragraph (a) below apply to a medicine that contains the ingredient that is:

- listed in the Register before 1 March 2021;

- released for supply before or on 1 March 2022; and

- the following warning statement is not specified on the label:

- (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect).

(a) When the medicine is not promoted or marketed as laxative, contains more than 2 g magnesium hydroxide per maximum recommended daily dose, the following warning statements are required on the label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'

- (LAX4) 'This product may have laxative effect'.

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 2021; or

- released for supply after 1 March 2022.

(b)  Magnesium is a mandatory component of magnesium hydroxide.

(c) When used in a medicine:

(i) with an oral route of administration;

(ii) not indicated for laxative (or related) use; and

(iii) where the maximum recommended daily dose for:

(A) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(C) 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).

(d) When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

3164

MAGNESIUM LYSINATE

A

Only for use in oral medicines.

 

3165

MAGNESIUM METHIONINATE

A

Only for use in oral medicines.

 

3166

MAGNESIUM NITRATE

E

Only for use in topical medicines for dermal application.

 

3167

MAGNESIUM OROTATE

A, E, H

 

3168

MAGNESIUM OROTATE DIHYDRATE

A, E, H

 

3169

MAGNESIUM OXIDE

A, E, H

The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2021; or

- released for supply after 1 March 2022.

(a) Magnesium is a mandatory component of magnesium oxide.

(b) When used in a medicine:

(i) with an oral route of administration;

(ii) not indicated for laxative (or related) use; and

(iii) where the maximum recommended daily dose for:

(A) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(C) 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).

(c) When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

3170

MAGNESIUM PHOSPHATE PENTAHYDRATE

A, E, H

The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2021; or

- released for supply after 1 March 2022.

(a) Magnesium is a mandatory component of magnesium phosphate pentahydrate.

(b) When used in a medicine:

(i) with an oral route of administration;

(ii) not indicated for laxative (or related) use; and

(iii) where the maximum recommended daily dose for:

(A) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(C) 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).

(c) 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 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.

The requirements specified in paragraphs (a) to (b) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2021; or

- released for supply after 1 March 2022.

(a) When used in a medicine:

(i) with an oral route of administration;

(ii) not indicated for laxative (or related) use; and

(iii) where the maximum recommended daily dose for:

(A) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(C) 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).

 (b) 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 PYRUVATE

A

Only for use in oral medicines.

The maximum recommended daily dose must be no more than 7 grams.

 

3173

MAGNESIUM STEARATE

E

 

3174

MAGNESIUM SULFATE DIHYDRATE

A, E, H

When used internally, the maximum recommended daily dose must not be more than 1.5g.

The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2021; or

- released for supply after 1 March 2022.

(a) Magnesium is a mandatory component of magnesium sulfate dihydrate.

(b) When used in a medicine:

(i) with an oral route of administration;

(ii) not indicated for laxative (or related) use; and

(iii) where the maximum recommended daily dose for:

(A) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(C) 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).

(c) When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

3175

MAGNESIUM SULFATE HEPTAHYDRATE

A, E, H

When used internally, the maximum recommended daily dose must not be more than 1.5 g.

The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2021; or

- released for supply after 1 March 2022.

(a) Magnesium is a mandatory component of magnesium sulfate heptahydrate.

(b) When used in a medicine:

(i) with an oral route of administration;

(ii) not indicated for laxative (or related) use; and

(iii) where the maximum recommended daily dose for:

(A) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(C) 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).

(c) When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

3176

MAGNESIUM SULFATE MONOHYDRATE

A, E, H

When used internally, the maximum recommended daily dose must not be more than 1.5 g.

The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2021; or

- released for supply after 1 March 2022.

(a) Magnesium is a mandatory component of magnesium sulfate monohydrate.

(b) When used in a medicine:

(i) with an oral route of administration;

(ii) not indicated for laxative (or related) use; and

(iii) where the maximum recommended daily dose for:

(A) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(C) 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).

(c) When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

3177

MAGNESIUM SULFATE TRIHYDRATE

A, E, H

When used internally, the maximum recommended daily dose must not be more than 1.5 g.

The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2021; or

- released for supply after 1 March 2022.

(a) Magnesium is a mandatory component of magnesium sulfate trihydrate.

(b) When used in a medicine:

(i) with an oral route of administration;

(ii) not indicated for laxative (or related) use; and

(iii) where the maximum recommended daily dose for:

(A) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(C) 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).

 (c) When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

3178

MAGNESIUM TRISILICATE

E

The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2021; or

- released for supply after 1 March 2022.

(a) Magnesium is a mandatory component of magnesium trisilicate.

(b) When used in a medicine:

(i) with an oral route of administration;

(ii) not indicated for laxative (or related) use; and

(iii) where the maximum recommended daily dose for:

(A) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(C) 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).

(c) When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

3179

MAGNOLIA GLAUCA

A, H

 

3180

MAGNOLIA LILIFLORA

A, H

 

3181

MAGNOLIA OBOVATA

A, H

 

3182

MAGNOLIA OFFICINALIS

A, E, H

 

3183

MAGNOLIA SALICIFOLIA

A, H

 

3184

MAIZE

E

 

3185

MAIZE BRAN

E

 

3186

MAIZE OIL

A, E, H

 

3187

MAIZE STARCH

A, E, H

 

3188

MALACHITE GREEN

E

Permitted for use only as a colour for topical use.

 

3189

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.

 

3190

MALPIGHIA GLABRA

A, E, H

 

3191

MALT EXTRACT

E

 

3192

MALTITOL

E

 

3193

MALTITOL SOLUTION

E

 

3194

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.

 

3195

MALTOL

E

 

3196

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%.

 

3197

MALTOSE

E

 

3198

MALUS DOMESTICA

A, E, H

The concentration of amygdalin in the medicine must be no more than 0%.

 

3199

MALUS SYLVESTRIS

A, H

 

3200

MALVA MOSCHATA

A, H

 

3201

MALVA SYLVESTRIS

A, E, H

 

3202

MALVA VERTICILLATA

A, H

 

3203

MANDARIN

E

 

3204

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%.

 

3205

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.

 

3206

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%.

 

3207

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%.

 

3208

MANDARINAL 32048

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

3209

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%.

 

3210

MANGANESE

H

Only for use as an active homoeopathic ingredient.

 

3211

MANGANESE (II) DIASPARTATE

A, H

Only for use in oral medicines.

 

3212

MANGANESE (II) GLYCINATE

A, H

Only for use in oral medicines.

 

3213

MANGANESE ACETATE TETRAHYDRATE

H

Only for use as an active homoeopathic ingredient. 

 

3214

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.

 

3215

MANGANESE CHLORIDE TETRAHYDRATE

A, E, H

 

3216

MANGANESE DIASPARTATE

A, E, H

Only for use in oral medicines.

 

3217

MANGANESE GLUCONATE

A, E, H

 

3218

MANGANESE GLYCEROPHOSPHATE

A, E, H

 

3219

MANGANESE OXIDE

A, E, H

 

3220

MANGANESE SULFATE MONOHYDRATE

A, E, H

 

3221

MANGANESE SULFATE TETRAHYDRATE

A, E, H

 

3222

MANGIFERA INDICA

A, E, H

 

3223

MANGO

E, H

 

3224

MANIHOT ESCULENTA

A, H

 

3225

MANNITOL

E

 

3226

MARANTA ARUNDINACEA

A, H

 

3227

MARINE SPONGE

H

Only for use as an active homoeopathic ingredient.

 

3228

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).

 

3229

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).

 

3230

MARRUBIUM VULGARE

A, E, H

 

3231

MARSDENIA CUNDURANGO

A, H

 

3232

MARSHMALLOW ROOT DRY

A, H

 

3233

MARSHMALLOW ROOT POWDER

A, H

 

3234

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%.

 

3235

MASTIC

A, H

 

3236

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%.

 

3237

MATRICARIA CHAMOMILLA

A, E, H

 

3238

MATRICARIA FLOWER DRY

A, E, H

 

3239

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'.

 

3240

MECOBALAMIN (CO-METHYLCOBALAMIN)

A

Only for use in oral medicines.

 

3241

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.

 

3242

MEDIUM CHAIN TRIGLYCERIDES

E

 

3243

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.

 

3244

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.

 

3245

MELALEUCA CITRINA

A, H

 

3246

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.

 

3247

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.

 

3248

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.

 

3249

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.

 

3250

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.

 

3251

MELICOPE PTELEIFOLIA

A, H

 

3252

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%.

 

3253

MELISSA OFFICINALIS

A, E, H

 

3254

MELON

E

 

3255

MENADIONE SODIUM BISULFITE

E

 

3256

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.

 

3257

MENISPERMUM CANADENSE

A, H

 

3258

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.

 

3259

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.

 

3260

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.

 

3261

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.

 

3262

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.

 

3263

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.

 

3264

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.

 

3265

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.

 

3266

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.

 

3267

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.

 

3268

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%.

 

3269

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%.

 

3270

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.

 

3271

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%.

 

3272

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%.

 

3273

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%.

 

3274

MENTHOXYPROPANEDIOL

E

For oral use only.

The concentration in the medicine must be no more than 0.04%.

 

3275

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%.

 

3276

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%.

 

3277

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).

 

3278

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%.

 

3279

MENTHYL LACTATE

E

 

3280

MENYANTHES TRIFOLIATA

A, H

 

3281

MERCURIC CHLORIDE

H

Only for use as an active homoeopathic ingredient.

 

3282

MERCURY

H

Only for use as an active homoeopathic ingredient.

 

3283

METACRESOL

E

Only for use in topical medicines for dermal application.

 

3284

METHACRYLIC ACID COPOLYMER

E

Only for use in oral medicines.

 

3285

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%.

 

3286

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%.

 

3287

METHIONINE

A, E

 

3288

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%.

 

3289

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%.

 

3290

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%.

 

3291

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%.

 

3292

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%.

 

3293

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%.

 

3294

METHYL ACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

 

3295

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%.

 

3296

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%.

 

3297

METHYL BENZOATE

E

Only for use in topical medicines for dermal application.

 

3298

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%.

 

3299

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%.

 

3300

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%.

 

3301

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%.

 

3302

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%.

 

3303

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%.

 

3304

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%.

 

3305

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%.

 

3306

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%.

 

3307

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%.

 

3308

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%.

 

3309

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%.

 

3310

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%.

 

3311

METHYL ETHER

E

Only for use in topical medicines for dermal application.

 

3312

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%.

 

3313

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%.

 

3314

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%.

 

3315

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.

 

3316

METHYL GLUCETH-20

E

Only for use in topical medicines for dermal application.

 

3317

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%.

 

3318

METHYL GLUCETH-20 SESQUIHYDRATE

E

Only for use in topical medicines for dermal application.

 

3319

METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

 

3320

METHYL GLUCOSE SESQUIOLEATE

E

Only for use in topical medicines for dermal application.

 

3321

METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

 

3322

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%.

 

3323

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%.

 

3324

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%.

 

3325

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%.

 

3326

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%.

 

3327

METHYL HYDROGENATED ROSINATE

E

Only for use in topical medicines for dermal application.

 

3328

METHYL HYDROJASMONATE

E

Only for use in topical medicines for dermal application.

 

3329

METHYL HYDROXYBENZOATE

E

 

3330

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%.

 

3331

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%.

 

3332

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%.

 

3333

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%.

 

3334

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%.

 

3335

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%.

 

3336

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%.

 

3337

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%.

 

3338

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%.

 

3339

METHYL METHACRYLATE

E

 

3340

METHYL METHACRYLATE CROSSPOLYMER

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 methyl methacrylate crosspolymer is greater than 1%, the medicine must not be intended for use on damaged skin.

The concentration in the medicine must not be more than 4.85%.

 

3341

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%.

 

3342

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%.

 

3343

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%.

 

3344

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%.

 

3345

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%.

 

3346

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%.

 

3347

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%.

 

3348

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%.

 

3349

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%.

 

3350

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%.

 

3351

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%.

 

3352

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%.

 

3353

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%.

 

3354

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'.

 

3355

METHYL STEARATE

E

 

3356

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%.

 

3357

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%.

 

3358

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%.

 

3359

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%.

 

3360

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%.

 

3361

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%.

 

3362

METHYLCELLULOSE

A, E

 

3363

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%.

 

3364

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%.

 

3365

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).

 

3366

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%.

 

3367

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%.

 

3368

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%.

 

3369

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%.

 

3370

METHYLSTYRENE/VINYLTOLUENE COPOLYMER

E

Only for use in topical medicines for dermal application.

 

3371

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%.

 

3372

MICROCALICIUM ARENARIUM

A, H

 

3373

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%.

 

3374

MICROCOS PANICULATA

A, H

 

3375

MICROCRYSTALLINE CELLULOSE

E

 

3376

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'.

 

3377

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%.

 

3378

MILK THISTLE FRUIT DRY

A, H

 

3379

MILK THISTLE FRUIT POWDER

A, H

 

3380

MILLET

E

 

3381

MILLETTIA DIELSIANA

A, H

 

3382

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%.

 

3383

MIMULUS GUTTATUS

A, H

 

3384

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.

 

3385

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%.

 

3386

MITCHELLA REPENS

A, H

 

3387

MIXED (HIGH-ALPHA TYPE) TOCOPHEROLS CONCENTRATE

A, E

 

3388

MIXED (LOW-ALPHA TYPE) TOCOPHEROLS CONCENTRATE

A, E

 

3389

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%.

 

3390

MODIFIED FOOD STARCH

E

 

3391

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%.

 

3392

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.

 

3393

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.

 

3394

MOMORDICA BALSAMINA

A, H

 

3395

MOMORDICA CHARANTIA

A, H

 

3396

MOMORDICA COCHINCHINENSIS

A, H

 

3397

MONARDA DIDYMA

A, H

 

3398

MONO- AND DI- GLYCERIDES

E

 

3399

MONOBASIC AMMONIUM PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

3400

MONOBASIC CALCIUM PHOSPHATE

A, E, H

 

3401

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.

 

3402

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.

 

3403

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.

 

3404

MONOETHANOLAMINE

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 5%.

 

3405

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.

 

3406

MONOPHOSPHOTHIAMINE

A

 

3407

MONOPHOSPHOTHIAMINE DIHYDRATE

A

 

3408

MONOPOTASSIUM GLUTAMATE

A, E

 

3409

MONOSODIUM DIHYDROGEN CITRATE

E

 

3410

MONOSODIUM GLUTAMATE MONOHYDRATE

A, E

 

3411

MONSTERA DELICIOSA

A, H

 

3412

MONTAN WAX

E

 

3413

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%..

 

3414

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).

 

3415

MORINDA OFFICINALIS

A, H

 

3416

MORINGA OLEIFERA

A, H

 

3417

MORUS ALBA

A, H

 

3418

MORUS BOMBYCIS

A, H

 

3419

MORUS NIGRA

A, E, H

 

3420

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%.

 

3421

MOTHERWORT HERB DRY

A, H

 

3422

MOTHERWORT HERB POWDER

A, H

 

3423

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%.

 

3424

MULBERRY

E

 

3425

MUNG BEAN

E

 

3426

MURRAYA KOENIGII

A, H

 

3427

MURRAYA PANICULATA

A, H

 

3428

MUSA X PARADISIACA

A, H

 

3429

MUSK KETONE

E

Only for use in topical medicines for dermal application.

 

3430

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%.

 

3431

MUSK XYLOL

E

Only for use in topical medicines for dermal application.

 

3432

MUSKS

H

Only for use as an active homoeopathic ingredient. 

 

3433

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%.

 

3434

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%.

 

3435

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%.

 

3436

MYOSOTIS ARVENSIS

A, H

 

3437

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%.

 

3438

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%.

 

3439

MYRICA CERIFERA

A, E, H

 

3440

MYRISTIC ACID

E

 

3441

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%.

 

3442

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).

 

3443

MYRISTYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

3444

MYRISTYL LACTATE

E

Only for use in topical medicines for dermal application.

 

3445

MYRISTYL MYRISTATE

E

Only for use in topical medicines for dermal application.

 

3446

MYROXYLON BALSAMUM

A, E, H

 

3447

MYROXYLON BALSAMUM VAR. PEREIRAE

A, H

 

3448

MYRRH

A, H

 

3449

MYRRH OIL

A, E, H

 

3450

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%.

 

3451

MYRRHIS ODORATA

A, H

 

3452

MYRSINE AFRICANA

A, H

 

3453

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%.

 

3454

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%.

 

3455

MYRTLE ESSENCE MAX

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

3456

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%.

 

3457

MYRTUS COMMUNIS

A, E, H

 

3458

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.

 

3459

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%.

 

3460

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%.

 

3461

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%.

 

3462

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%.

 

3463

NAPHTHALENE

H

Only for use as an active homoeopathic ingredient. 

 

3464

NARDOSTACHYS CHINENSIS

A, H

 

3465

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%.

 

3466

NASTURTIUM OFFICINALE

A, E, H

 

3467

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.

 

3468

NAUCLEA OFFICINALIS

A, H

 

3469

NELUMBO NUCIFERA

A, H

 

3470

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%.

 

3471

NEOHESPERIDIN-DIHYDROCHALCONE

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%

 

3472

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%.

 

3473

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%.

 

3474

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%. 

 

3475

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.

 

3476

NEOPENTYL GLYCOL DIOCTANOATE/DIDECANOATE

E

Only for use in topical medicines for dermal application.

 

3477

NEOPICRORHIZA SCROPHULARIIFLORA

A, H

 

3478

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%.

 

3479

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%.

 

3480

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%.

 

3481

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%.

 

3482

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%.

 

3483

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%.

 

3484

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%.

 

3485

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%.

 

3486

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%.

 

3487

NICKEL

H

Only for use as an active homoeopathic ingredient.

 

3488

NICOTIANA TABACUM

H

Only for use as an active homoeopathic ingredient.

 

3489

NICOTINAMIDE

A, E, H

 

3490

NICOTINAMIDE ASCORBATE

A, E

 

3491

NICOTINAMIDE RIBOSIDE CHLORIDE

A

Only to be used in a medicine where Chromadex Inc (Client ID 68566), 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 02 December 2021.

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’.

 

3492

NICOTINIC ACID

A, E

The medicine must contain no more than 100 mg of nicotinic acid per dosage unit.

 

3493

NIGELLA DAMASCENA

A, H

 

3494

NIGELLA SATIVA

A, E, H

 

3495

NITRIC ACID

E, H

The concentration of nitric acid in the medicine must be no more than 0.5%.

 

3496

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%.

 

3497

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%.

 

3498

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%.

 

3499

NONFAT DRY MILK

E, H

 

3500

NONIVAMIDE

E

Permitted for use only in combination with 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

NONOXINOL 10

E

Only for use in topical medicines for dermal application.

 

3502

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%.

 

3503

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%.

 

3504

NONOXINOL 9

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 25%.

 

3505

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%.

 

3506

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%.

 

3507

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%.

 

3508

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%.

 

3509

NOTOPTERYGIUM FORBESII

A, H

 

3510

NOTOPTERYGIUM INCISIUM

A, H

 

3511

NUPHAR JAPONICA

A, H

 

3512

NUPHAR LUTEA

A, H

 

3513

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%.

 

3514

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).

 

3515

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%.

 

3516

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%.

 

3517

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%.

 

3518

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'.

 

3519

NYLON

E

Only for use in topical medicines for dermal application.

 

3520

NYLON 6/12

E

Only for use in topical medicines for dermal application.

 

3521

NYLON-12

E

Only for use in topical medicines for dermal application.

 

3522

NYMPHAEA ALBA

A, E, H

 

3523

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.

 

3524

NYMPHAEA ODORATA

A, H

 

3525

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%.

 

3526

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%.

 

3527

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.

 

3528

OAT BRAN

E

Gluten is a mandatory component of Oat bran when the route of administration is other than topical and mucosal.

 

3529

OATMEAL COLLOIDAL

A, E

Gluten is a mandatory component of Oatmeal colloidal when the route of administration is other than topical and mucosal.

 

3530

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%.

 

3531

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%.

 

3532

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%.

 

3533

OCIMUM KILIMANDSCHARICUM

A, H

Camphor is a mandatory component of Ocimum kilimandscharicum.

In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%.

In liquid preparations, the nominal capacity of the container must be no more than 25 millilitres.

In liquid preparations other than essential oils or distillates, the concentration of camphor must be no more than 2.5%.

In essential oil or distillate preparations when the concentration of camphor is more than 2.5%, 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 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 also have a child resistant closure fitted on the container.

 

3534

OCIMUM MINIMUM

A, H

 

3535

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%.

 

3536

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%.

 

3537

OCTACOSANOL

E

 

3538

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%.

 

3539

OCTADECENE/MA COPOLYMER

E

Only for use in topical medicines for dermal application.

 

3540

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%.

 

3541

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%.

 

3542

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%.

 

3543

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%.

 

3544

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%.

 

3545

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%.

 

3546

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%.

 

3547

OCTHILINONE

E

Only for use in topical medicines for dermal application.

 

3548

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).

 

3549

OCTOXINOL 10

E

Only for use in topical medicines for dermal application.

 

3550

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%.

 

3551

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.

 

3552

OCTYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

 

3553

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%.

 

3554

OCTYL ISONONANOATE

E

Only for use in topical medicines for dermal application.

 

3555

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).

 

3556

OCTYL PALMITATE

E

Only for use in topical medicines for dermal application.

 

3557

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).

 

3558

OCTYL STEARATE

E

Only for use in topical medicines for dermal application.

 

3559

OCTYLBICYCLOHEPTENEDICARBOXIMIDE

E

Only for use in topical medicines for dermal application.

The medicine requires the following warning statement on the medicine label:

- (OBCARB) 'Contains octylbicycloheptenedicarboximide' (or words to that effect).

 

3560

OCTYLDODECANOL

E

Only for use in topical medicines for dermal application.

 

3561

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.

 

3562

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%.

 

3563

OCTYLDODECYL NEOPENTANOATE

E

Only for use in topical medicines for dermal application.

 

3564

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%.

 

3565

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%.

 

3566

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%.

 

3567

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.

 

3568

OENANTHE CROCATA

A, H

The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material.

 

3569

OENOTHERA BIENNIS

A, E, H

 

3570

OENOTHERA STRICTA

A, H

 

3571

OKOUBAKA AUBREVILLEI

A, H

 

3572

OLDENLANDIA DIFFUSA

A, E, H

 

3573

OLEA EUROPAEA

A, E, H

 

3574

OLEIC ACID

E

 

3575

OLETH-10

E

Only for use in topical medicines for dermal application.

 

3576

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%.

 

3577

OLETH-20

E

Only for use in topical medicines for dermal application.

 

3578

OLETH-3

E

Only for use in topical medicines for dermal application.

 

3579

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%.

 

3580

OLETH-5

E

Only for use in topical medicines for dermal application.

 

3581

OLEYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

3582

OLIBANUM OIL

A, E, H

 

3583

OLIVE

E

 

3584

OLIVE OIL

A, E, H

 

3585

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).'

 

3586

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).

 

3587

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.'

 

3588

ONION

E

 

3589

ONION OIL

A, H

 

3590

ONONIS SPINOSA

A, E, H

 

3591

ONOPORDUM ACANTHIUM

A, H

 

3592

ONOSMODIUM VIRGINIANUM

A, H

 

3593

OPHIOPOGON JAPONICUS

A, H

 

3594

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%.

 

3595

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%.

 

3596

OPUNTIA FICUS-INDICA

A, H

 

3597

ORANGE

E

 

3598

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%.

 

3599

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.

 

3600

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%.

 

3601

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%.

 

3602

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.

 

3603

ORANGE OIL BITTER

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavor, the total flavour concentration in a 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 warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' or words to that effect must be include on the medicine label unless the medicine is:

a) for internal use;

b) in preparations containing 1.4% or less of orange oil bitter;

c) for use in soaps or bath or shower gels that are washed off the skin.

 

3604

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.

 

3605

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%.

 

3606

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.

 

3607

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%.

 

3608

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.

 

3609

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%.

 

3610

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.

 

3611

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%.

 

3612

ORANGE ROUGHY OIL

E

Only for use in topical medicines for dermal application.

 

3613

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).

 

3614

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%.

 

3615

ORIGANUM OIL SPANISH

A, E, H

 

3616

ORIGANUM VULGARE

A, E, H

 

3617

ORNITHINE

A, E

 

3618

ORNITHINE ASPARTATE

A, E

 

3619

ORNITHINE MONOHYDROCHLORIDE

A, E

 

3620

ORNITHOGALUM UMBELLATUM

A, H

 

3621

OROSTACHYS FIMBRIATA

A, H

 

3622

OROXYLUM INDICUM

A, H

 

3623

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%.

 

3624

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%.

 

3625

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%.

 

3626

ORRIS ROOT OIL

A, E, H

 

3627

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%.

 

3628

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%.

 

3629

ORTHOSIPHON ARISTATUS

A, H

 

3630

ORYZA SATIVA

A, E, H

 

3631

ORYZANOL

E

 

3632

OSBECKIA CHINENSIS

A, H

 

3633

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%.

 

3634

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%.

 

3635

OTTELIA ALISMOIDES

A, H

 

3636

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%.

 

3637

OXACYCLOHEXADECAN-2-ONE

E

Only for use in topical medicines for dermal application.

 

3638

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%.

 

3639

OXALIC ACID

H

Only for use as an active homoeopathic ingredient. 

 

3640

OXALIS ACETOSELLA

A, H

 

3641

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%.

 

3642

OXIDISED TAPIOCA STARCH

E

 

3643

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).

 

3644

OYSTER

E

 

3645

OYSTER SHELL

A, E, H