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. 4) 2020 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 26 Feb 2021
Tabling HistoryDate
Tabled HR15-Mar-2021
Tabled Senate15-Mar-2021
Date of repeal 20 Aug 2021
Repealed by Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2021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

2859

KADSURA COCCINEA

A, H

 

2860

KAEMPFERIA GALANGA

A, H

 

2861

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%.

 

2862

KAOLIN

E

 

2863

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.

 

2864

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.

 

2865

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%.

 

2866

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%. 

 

2867

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'.

 

2868

KIDNEY BEAN

E

 

2869

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%.

 

2870

KIWI FRUIT

E

 

2871

KNAUTIA ARVENSIS

A, H

 

2872

KOREAN GINSENG ROOT DRY

A, H

 

2873

KOREAN GINSENG ROOT POWDER

A, H

 

2874

KRAMERIA IXIENA

A, H

 

2875

KRAMERIA LAPPACEA

A, H

 

2876

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'.

 

2877

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%.

 

2878

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%.

 

2879

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%.

 

2880

L-LIMONENE

E

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

If used in a flavour the total flavour concentration in a 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-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%.

 

2882

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%.

 

2883

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%.

 

2884

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%.

 

2885

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%.

 

2886

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%.

 

2887

LABDANUM OIL

A, E, H

 

2888

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%.

 

2889

LACTALBUMIN

E

 

2890

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.

 

2891

LACTITOL

E

 

2892

LACTITOL MONOHYDRATE

E

 

2893

LACTOBACILLUS ACIDOPHILUS

A

 

2894

LACTOBACILLUS AMYLOVORUS

A

 

2895

LACTOBACILLUS BREVIS

A

 

2896

LACTOBACILLUS CASEI

A

 

2897

LACTOBACILLUS CASEI SUBSP. BIOVAR CASEI

A

 

2898

LACTOBACILLUS CRISPATUS

A

 

2899

LACTOBACILLUS DELBRUECKII SSP BULGARICUS

A

 

2900

LACTOBACILLUS DELBRUECKII SSP LACTIS

A

 

2901

LACTOBACILLUS FERMENTUM

A

 

2902

LACTOBACILLUS GALLINARUM

A

 

2903

LACTOBACILLUS GASSERI

A

 

2904

LACTOBACILLUS HELVETICUS

A

 

2905

LACTOBACILLUS JOHNSONII

A

 

2906

LACTOBACILLUS KEFIRANOFACIENS

A

 

2907

LACTOBACILLUS KEFIRGRANUM

A

 

2908

LACTOBACILLUS KEFIRI

A

 

2909

LACTOBACILLUS PARACASEI

A

 

2910

LACTOBACILLUS PARACASEI SUBSP. PARACASEI

A

 

2911

LACTOBACILLUS PLANTARUM

A

 

2912

LACTOBACILLUS REUTERI

A

 

2913

LACTOBACILLUS RHAMNOSUS

A

 

2914

LACTOBACILLUS SALIVARIUS SSP SALICINIUS

A

 

2915

LACTOBACILLUS SALIVARIUS SSP SALIVARIUS

A

 

2916

LACTOBIONIC ACID

E

Only for use in topical medicines for dermal application.

 

2917

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%.

 

2918

LACTOSE

E

 

2919

LACTOSE MONOHYDRATE

E

 

2920

LACTUCA SATIVA

A, H

 

2921

LACTUCA VIROSA

A, H

 

2922

LACTULOSE

E

 

2923

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.

 

2924

LAGENARIA VULGARIS

A, H

 

2925

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.

 

2926

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.

 

2927

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.

 

2928

LAMIUM ALBUM

A, H

 

2929

LANETH-5

E

Only for use in topical medicines for dermal application.

 

2930

LANOLIN ALCOHOL

E

Only for use in topical medicines for dermal application.

 

2931

LANOLIN OIL

E

Only for use in topical medicines for dermal application.

 

2932

LANOLIN WAX

E

Only for use in topical medicines for dermal application.

 

2933

LANTANA CAMARA

A, H

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

 

2934

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%.

 

2935

LARIX DECIDUA

A, H

 

2936

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.

 

2937

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'.

 

2938

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.

 

2939

LAURAMINE OXIDE

E

 

2940

LAUREL LEAF OIL

A, H

 

2941

LAURETH-10

E

Only for use in topical medicines for dermal application.

 

2942

LAURETH-12

E

Only for use in topical medicines for dermal application.

 

2943

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.

 

2944

LAURETH-23

E

Only for use in topical medicines for dermal application.

 

2945

LAURETH-3

E

Only for use in topical medicines for dermal application.

 

2946

LAURETH-4

E

Only for use in topical medicines for dermal application.

 

2947

LAURETH-7

E

Only for use in topical medicines for dermal application.

 

2948

LAURETH-8

E

 

2949

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.

 

2950

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%.

 

2951

LAUROMACROGOL 400

E

Only for use in topical medicines for dermal application.

 

2952

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%.

 

2953

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'.

 

2954

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%.

 

2955

LAURYL BETAINE

E

Only for use in topical medicines for dermal application.

 

2956

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%.

 

2957

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.

 

2958

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%.

 

2959

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%.

 

2960

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%.

 

2961

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.

 

2962

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.

 

2963

LAURYL PYRROLIDONE

E

Only for use in topical medicines for dermal application.

 

2964

LAURYLDIMONIUM HYDROXYPROPYL HYDROLYSED COLLAGEN

E

Only for use in topical medicines for dermal application.

 

2965

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%.

 

2966

LAURYLMETICONE COPOLYOL

E

Only for use in topical medicines for dermal application.

 

2967

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%.

 

2968

LAVANDIN OIL ABRIAL

A, E, H

 

2969

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%.

 

2970

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%.

 

2971

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%.

 

2972

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%.

 

2973

LAVENDER OIL

A, E, H

 

2974

LAWSONIA INERMIS

A, H

 

2975

LEAD

H

Only for use as an active homoeopathic ingredient.

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

 

2976

LEAD ACETATE

H

Only for use as an active homoeopathic ingredient.

 

2977

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%.

 

2978

LECITHIN

A, E

 

2979

LEDEBOURIELLA SESELOIDES

A, H

 

2980

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.

 

2981

LEMNA MINOR

A, H

 

2982

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.

 

2983

LEMON BALM LEAF DRY

A, H

 

2984

LEMON BALM LEAF POWDER

A, E, H

 

2985

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.

 

2986

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.

 

2987

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.

 

2988

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%.

 

2989

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.

 

2990

LEMONGRASS OIL

A, E, H

 

2991

LENS CULINARIS

A, H

 

2992

LENTIL

E

 

2993

LENTINULA EDODES

A, E, H

 

2994

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%.

 

2995

LEONURUS CARDIACA

A, E, H

 

2996

LEONURUS SIBIRICUS

A, E, H

 

2997

LEPIDIUM APETALUM

A, H

 

2998

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).

 

2999

LEPTOSPERMUM PETERSONII

E

Only for use in topical medicines for dermal application.

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

 

3000

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’

 

3001

LESPEDEZA CAPITATA

A, H

 

3002

LETTUCE

E

 

3003

LEUCINE

A, E

 

3004

LEUZEA UNIFLORUM

A, H

 

3005

LEVISTICUM OFFICINALE

A, H

 

3006

LEVOCARNITINE

A

 

3007

LEVOCARNITINE FUMARATE

A

 

3008

LEVOCARNITINE HYDROCHLORIDE

A

 

3009

LEVOCARNITINE MAGNESIUM CITRATE

A

 

3010

LEVOCARNITINE TARTRATE

A

 

3011

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.

 

3012

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.

 

3013

LEVOTHYROXINE SODIUM

H

Only for use as an active homoeopathic ingredient.

 

3014

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%.

 

3015

LIGHT KAOLIN

E

 

3016

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.

 

3017

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.

 

3018

LIGUSTICUM SINENSE

A, H

 

3019

LIGUSTICUM STRIATUM

A, E, H

 

3020

LIGUSTRUM LUCIDUM

A, H

 

3021

LILIUM BROWNII

A, H

 

3022

LILIUM CANDIDUM

A, E, H

 

3023

LILIUM LANCIFOLIUM

A, H

 

3024

LILIUM LONGIFLORUM

A, H

 

3025

LIME FRUIT

E

 

3026

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%.

 

3027

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.

 

3028

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.

 

3029

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%.

 

3030

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%.

 

3031

LIME TREE FLOWER DRY

A, H

 

3032

LIME TREE FLOWER POWDER

A, H

 

3033

LIME, ESSENCE

E

 

3034

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%.

 

3035

LIMONENE

E

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

 

3036

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%.

 

3037

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%.

 

3038

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%.

 

3039

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%.

 

3040

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%.

 

3041

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%.

 

3042

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%.

 

3043

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%.

 

3044

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%.

 

3045

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%.

 

3046

LINDERA STRYCHNIFOLIA

A, H

 

3047

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%.

 

3048

LINOLEIC ACID

E

 

3049

LINOLENIC ACID

E

 

3050

LINSEED DRY

A, E, H

 

3051

LINSEED OIL

A, E, H

 

3052

LINSEED POWDER

A, E, H

 

3053

LINUM USITATISSIMUM

A, E, H

 

3054

LIPASE

A

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

 

3055

LIPPIA DULCIS

A, H

 

3056

LIQUID GLUCOSE

E

 

3057

LIQUID PARAFFIN

A, E

When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time.

 

3058

LIQUIDAMBAR FORMOSANA

A, H

 

3059

LIQUIDAMBAR ORIENTALIS

A, H

 

3060

LIQUIDAMBAR STYRACIFLUA

A, E, H

 

3061

LIQUIDAMBAR STYRACIFLUA RESIN

E

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

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

 

3062

LIQUIDAMBAR TAIWANIANA

A, H

 

3063

LIQUORICE

E

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

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

3064

LIQUORICE DRY

A, E, H

 

3065

LIQUORICE LIQUID EXTRACT

A, E, H

 

3066

LIQUORICE POWDER

A, E, H

 

3067

LITCHI CHINENSIS

A, H

 

3068

LITHIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

 

3069

LITHOSPERMUM OFFICINALE

A, H

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

 

3070

LITSEA CUBEBA

A, E, H

 

3071

LITSEA CUBEBA OIL

E

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

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

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

 

3072

LOBARIA PULMONARIA

A, H

 

3073

LOBELIA DRY

A, H

The concentration in the medicine must be no more than 0.001% or 10mg/kg or 10ml/L or 10 ppm unless the medicine is administered by inhalation.

 

3074

LOBELIA INFLATA

A, H

The concentration in the medicine must be no more than 0.001% or 10mg/kg or 10ml/L or 10 ppm unless the medicine is administered by inhalation.

 

3075

LOBELIA POWDER

A, H

The concentration in the medicine must be no more than 0.001% or 10mg/kg or 10ml/L or 10 ppm unless the medicine is administered by inhalation.

 

3076

LOLIUM PERENNE

A, H

 

3077

LOLIUM TEMULENTUM

A, H

 

3078

LONGIFOLENE

E

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

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

 

3079

LONICERA CAPRIFOLIUM

A, E, H

 

3080

LONICERA JAPONICA

A, E, H

 

3081

LONICERA PERICLYMENUM

A, H

 

3082

LOPHATHERUM GRACILE

A, H

 

3083

LOQUAT

E

 

3084

LORANTHUS PARASITICUS

A, H

 

3085

LOROPETALUM CHINENSIS

A, H

 

3086

LOTUS CORNICULATUS

A, H

 

3087

LOVAGE OIL

A, E, H

 

3088

LOVAGE ROOT DRY

A, H

 

3089

LOVAGE ROOT POWDER

A, H

 

3090

LUDWIGIA PROSTRATA

A, H

 

3091

LUFFA CYLINDRICA

A, H

 

3092

LUFFA PURGANS

A, H

 

3093

LUTEIN

A, E, H

When used as an excipient, permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

3094

LYCHEE

E

 

3095

LYCIUM BARBARUM

A, H

 

3096

LYCIUM CHINENSE

A, E, H

 

3097

LYCOPENE

A, E

 

3098

LYCOPERSICON ESCULENTUM

A, E, H

Steroidal alkaloids calculated as solanine is a mandatory component of Lycopersicon esculentum.

The maximum daily dose must not provide more than 10 mg of steroidal alkaloids calculated as solanine.

 

3099

LYCOPODIUM ANNOTINUM

A, H

 

3100

LYCOPODIUM CLAVATUM

A, H

 

3101

LYCOPODIUM COMPLANATUM

A, H

 

3102

LYCOPUS EUROPAEUS

A, H

 

3103

LYCOPUS LUCIDUS

A, H

 

3104

LYCOPUS VIRGINICUS

A, H

Pulegone is a mandatory component of Lycopus virginicus.

The concentration of pulegone in the medicine must be no more than 4%.

 

3105

LYGODIUM JAPONICUM

A, H

 

3106

LYSIMACHIA CHRISTINAE

A, H

 

3107

LYSIMACHIA VULGARIS

A, H

 

3108

LYSINE

A, E

 

3109

LYSINE HYDROCHLORIDE

A, E

 

3110

LYTHRUM HYSSOPIFOLIA

A, H

 

3111

LYTHRUM SALICARIA

A, H

 

3112

LYTHRUM VERTICILLATUM

A, H

 

3113

MACADAMIA INTEGRIFOLIA

A, E

 

3114

MACADAMIA NUT

E

 

3115

MACADAMIA NUT OIL

E

 

3116

MACADAMIA TERNIFOLIA

A, E, H

 

3117

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%.

 

3118

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.

 

3119

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.

 

3120

MACROGOL 1000

E

 

3121

MACROGOL 1450

E

Only for use in topical medicines for dermal application.

 

3122

MACROGOL 1500

E

 

3123

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%.

 

3124

MACROGOL 200

E

Only for use in topical medicines for dermal application.

 

3125

MACROGOL 20000

E

 

3126

MACROGOL 300

E

 

3127

MACROGOL 3000

E

 

3128

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.

 

3129

MACROGOL 40

E

Only for use in topical medicines for dermal application.

 

3130

MACROGOL 400

E

 

3131

MACROGOL 4000

E

 

3132

MACROGOL 45000

E

Only for use in topical medicines for dermal application.

 

3133

MACROGOL 600

E

 

3134

MACROGOL 6000

E

 

3135

MACROGOL 600000

E

 

3136

MACROGOL 800

E

 

3137

MACROGOL 8000

E

 

3138

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%.

 

3139

MACROGOL POLY(VINYL ALCOHOL) GRAFTED POLYMER

E

Only for use in oral medicines.

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

 

3140

MACROPIPER EXCELSUM VAR EXCELSUM

A, H

 

3141

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.

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 amino acid chelate.

(b) When used in a medicine:

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

(ii) 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) the medicine must not be directed for use in infants younger than 12 months of age.

 

3142

MAGNESIUM ASCORBATE

A, E, H

 

3143

MAGNESIUM ASCORBATE MONOHYDRATE

A, E, H

 

3144

MAGNESIUM ASCORBYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

3145

MAGNESIUM ASPARTATE

A, E, H

 

3146

MAGNESIUM ASPARTATE DIHYDRATE

A, E, H

 

3147

MAGNESIUM ASPARTATE TETRAHYDRATE

A, E, H

 

3148

MAGNESIUM CARBONATE HYDRATE

A, E, H

 

3149

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.

 

3150

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.

 

3151

MAGNESIUM CITRATE

A, E, H

 

3152

MAGNESIUM CITRATE NONAHYDRATE

A, E, H

 

3153

MAGNESIUM CITRATE TETRADECAHYDRATE

A, E, H

 

3154

MAGNESIUM DIGLUTAMATE

A, E, H

 

3155

MAGNESIUM GLUCONATE

A, E, H

 

3156

MAGNESIUM GLYCEROPHOSPHATE

A, E, H

 

3157

MAGNESIUM GLYCINATE

A

Only for use in oral medicines.

 

3158

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.

 

3159

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.

 

3160

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.

 

3161

MAGNESIUM LYSINATE

A

Only for use in oral medicines.

 

3162

MAGNESIUM METHIONINATE

A

Only for use in oral medicines.

 

3163

MAGNESIUM NITRATE

E

Only for use in topical medicines for dermal application.

 

3164

MAGNESIUM OROTATE

A, E, H

 

3165

MAGNESIUM OROTATE DIHYDRATE

A, E, H

 

3166

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.

 

3167

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.

 

3168

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.

 

3169

MAGNESIUM PYRUVATE

A

Only for use in oral medicines.

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

 

3170

MAGNESIUM STEARATE

E

 

3171

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.

 

3172

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.

 

3173

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.

 

3174

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.

 

3175

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.

 

3176

MAGNOLIA GLAUCA

A, H

 

3177

MAGNOLIA LILIFLORA

A, H

 

3178

MAGNOLIA OBOVATA

A, H

 

3179

MAGNOLIA OFFICINALIS

A, E, H

 

3180

MAGNOLIA SALICIFOLIA

A, H

 

3181

MAIZE

E

 

3182

MAIZE BRAN

E

 

3183

MAIZE OIL

A, E, H

 

3184

MAIZE STARCH

A, E, H

 

3185

MALACHITE GREEN

E

Permitted for use only as a colour for topical use.

 

3186

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.

 

3187

MALPIGHIA GLABRA

A, E, H

 

3188

MALT EXTRACT

E

 

3189

MALTITOL

E

 

3190

MALTITOL SOLUTION

E

 

3191

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.

 

3192

MALTOL

E

 

3193

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%.

 

3194

MALTOSE

E

 

3195

MALUS DOMESTICA

A, E, H

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

 

3196

MALUS PUMILA

A, E, H

A medicine that contains the ingredient must not be listed in the Register on or after 2 March 2020 or be released for supply after 2 March 2021.

 

3197

MALUS SYLVESTRIS

A, H

 

3198

MALVA MOSCHATA

A, H

 

3199

MALVA SYLVESTRIS

A, E, H

 

3200

MALVA VERTICILLATA

A, H

 

3201

MANDARIN

E

 

3202

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%.

 

3203

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.

 

3204

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%.

 

3205

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%.

 

3206

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%.

 

3207

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%.

 

3208

MANGANESE

H

Only for use as an active homoeopathic ingredient.

 

3209

MANGANESE (II) DIASPARTATE

A, H

Only for use in oral medicines.

 

 

3210

MANGANESE (II) GLYCINATE

A, H

Only for use in oral medicines.

 

3211

MANGANESE ACETATE TETRAHYDRATE

H

Only for use as an active homoeopathic ingredient. 

 

3212

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.

 

3213

MANGANESE CHLORIDE TETRAHYDRATE

A, E, H

 

3214

MANGANESE DIASPARTATE

A, E, H

Only for use in oral medicines.

 

3215

MANGANESE GLUCONATE

A, E, H

 

3216

MANGANESE GLYCEROPHOSPHATE

A, E, H

 

3217

MANGANESE OXIDE

A, E, H

 

3218

MANGANESE SULFATE MONOHYDRATE

A, E, H

 

3219

MANGANESE SULFATE TETRAHYDRATE

A, E, H

 

3220

MANGIFERA INDICA

A, E, H

 

3221

MANGO

E, H

 

3222

MANIHOT ESCULENTA

A, H

 

3223

MANNITOL

E

 

3224

MARANTA ARUNDINACEA

A, H

 

3225

MARINE SPONGE

H

Only for use as an active homoeopathic ingredient.

 

3226

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).

 

3227

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).

 

3228

MARRUBIUM VULGARE

A, E, H

 

3229

MARSDENIA CUNDURANGO

A, H

 

3230

MARSHMALLOW ROOT DRY

A, H

 

3231

MARSHMALLOW ROOT POWDER

A, H

 

3232

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%.

 

3233

MASTIC

A, H

 

3234

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%.

 

3235

MATRICARIA CHAMOMILLA

A, E, H

 

3236

MATRICARIA FLOWER DRY

A, E, H

 

3237

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'.

 

3238

MECOBALAMIN (CO-METHYLCOBALAMIN)

A

Only for use in oral medicines.

 

3239

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.

 

3240

MEDIUM CHAIN TRIGLYCERIDES

E

 

3241

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.

 

 

3242

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.

 

3243

MELALEUCA CITRINA

A, H

 

3244

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.

 

3245

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.

 

3246

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.

 

3247

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.

 

3248

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.

 

3249

MELICOPE PTELEIFOLIA

A, H

 

3250

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%.

 

3251

MELISSA OFFICINALIS

A, E, H

 

3252

MELON

E

 

3253

MENADIONE SODIUM BISULFITE

E

 

3254

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.

 

3255

MENISPERMUM CANADENSE

A, H

 

3256

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.

 

3257

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.

 

3258

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.

 

3259

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.

 

3260

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.

 

3261

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.

 

3262

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.

 

3263

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.

 

3264

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.

 

3265

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.

 

3266

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%.

 

3267

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%.

 

3268

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.

 

3269

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%.

 

3270

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%.

 

3271

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%.

 

3272

MENTHOXYPROPANEDIOL

E

For oral use only.

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

 

3273

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%.

 

3274

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%.

 

3275

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).

 

3276

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%.

 

3277

MENTHYL LACTATE

E

 

3278

MENYANTHES TRIFOLIATA

A, H

 

3279

MERCURIC CHLORIDE

H

Only for use as an active homoeopathic ingredient.

 

3280

MERCURY

H

Only for use as an active homoeopathic ingredient.

 

3281

METACRESOL

E

Only for use in topical medicines for dermal application.

 

3282

METHACRYLIC ACID COPOLYMER

E

Only for use in oral medicines.

 

3283

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%.

 

3284

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%.

 

3285

METHIONINE

A, E

 

3286

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%.

 

3287

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%.

 

3288

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%.

 

3289

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%.

 

3290

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%.

 

3291

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%.

 

3292

METHYL ACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

 

3293

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%.

 

3294

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%.

 

3295

METHYL BENZOATE

E

Only for use in topical medicines for dermal application.

 

3296

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%.

 

3297

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%.

 

3298

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%.

 

3299

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%.

 

3300

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%.

 

3301

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%.

 

3302

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%.

 

3303

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%.

 

3304

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%.

 

3305

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%.

 

3306

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%.

 

3307

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%.

 

3308

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%.

 

3309

METHYL ETHER

E

Only for use in topical medicines for dermal application.

 

3310

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%.

 

3311

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%.

 

3312

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%.

 

3313

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.

 

3314

METHYL GLUCETH-20

E

Only for use in topical medicines for dermal application.

 

3315

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%.

 

3316

METHYL GLUCETH-20 SESQUIHYDRATE

E

Only for use in topical medicines for dermal application.

 

3317

METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

 

3318

METHYL GLUCOSE SESQUIOLEATE

E

Only for use in topical medicines for dermal application.

 

3319

METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

 

3320

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%.

 

3321

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%.

 

3322

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%.

 

3323

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%.

 

3324

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%.

 

3325

METHYL HYDROGENATED ROSINATE

E

Only for use in topical medicines for dermal application.

 

3326

METHYL HYDROJASMONATE

E

Only for use in topical medicines for dermal application.

 

3327

METHYL HYDROXYBENZOATE

E

 

3328

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%.

 

3329

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%.

 

3330

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%.

 

3331

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%.

 

3332

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%.

 

3333

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%.

 

3334

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%.

 

3335

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%.

 

3336

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%.

 

3337

METHYL METHACRYLATE

E

 

3338

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%.

 

3339

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%.

 

3340

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%.

 

3341

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%.

 

3342

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%.

 

3343

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%.

 

3344

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%.

 

3345

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%.

 

3346

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%.

 

3347

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%.

 

3348

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%.

 

3349

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%.

 

3350

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%.

 

3351

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%.

 

3352

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'.

 

3353

METHYL STEARATE

E

 

3354

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%.

 

3355

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%.

 

3356

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%.

 

3357

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%.

 

3358

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%.

 

3359

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%.

 

3360

METHYLCELLULOSE

A, E

 

3361

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%.

 

3362

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%.

 

3363

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).

 

3364

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%.

 

3365

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%.

 

3366

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%.

 

3367

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%.

 

3368

METHYLSTYRENE/VINYLTOLUENE COPOLYMER

E

Only for use in topical medicines for dermal application.

 

3369

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%.

 

3370

MICROCALICIUM ARENARIUM

A, H

 

3371

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%.

 

3372

MICROCOS PANICULATA

A, H

 

3373

MICROCRYSTALLINE CELLULOSE

E

 

3374

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'.

 

3375

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%.

 

3376

MILK THISTLE FRUIT DRY

A, H

 

3377

MILK THISTLE FRUIT POWDER

A, H

 

3378

MILLET

E

 

3379

MILLETTIA DIELSIANA

A, H

 

3380

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%.

 

3381

MIMULUS GUTTATUS

A, H

 

3382

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.

 

3383

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%.

 

3384

MITCHELLA REPENS

A, H

 

3385

MIXED (HIGH-ALPHA TYPE) TOCOPHEROLS CONCENTRATE

A, E

 

3386

MIXED (LOW-ALPHA TYPE) TOCOPHEROLS CONCENTRATE

A, E

 

3387

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%.

 

3388

MODIFIED FOOD STARCH

E

 

3389

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%.

 

3390

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.

 

3391

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.

 

3392

MOMORDICA BALSAMINA

A, H

 

3393

MOMORDICA CHARANTIA

A, H

 

3394

MOMORDICA COCHINCHINENSIS

A, H

When Lycopene, Lutein or Betocarotene are declared as components, the plant part is restricted to fruit flesh, fruit peel or seed aril.

 

3395

MONARDA DIDYMA

A, H

 

3396

MONO- AND DI- GLYCERIDES

E

 

3397

MONOBASIC AMMONIUM PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

3398

MONOBASIC CALCIUM PHOSPHATE

A, E, H

 

3399

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.

 

3400

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.

 

3401

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.

 

3402

MONOETHANOLAMINE

E

Only for use in topical medicines for dermal application.

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

 

3403

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.

 

3404

MONOPHOSPHOTHIAMINE

A

 

3405

MONOPHOSPHOTHIAMINE DIHYDRATE

A

 

3406

MONOPOTASSIUM GLUTAMATE

A, E

 

3407

MONOSODIUM DIHYDROGEN CITRATE

E

 

3408

MONOSODIUM GLUTAMATE MONOHYDRATE

A, E

 

3409

MONSTERA DELICIOSA

A, H

 

3410

MONTAN WAX

E

 

3411

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%..

 

3412

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).

 

3413

MORINDA OFFICINALIS

A, H

 

3414

MORINGA OLEIFERA

A, H

 

3415

MORUS ALBA

A, H

 

3416

MORUS BOMBYCIS

A, H

 

3417

MORUS NIGRA

A, E, H

 

3418

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%.

 

3419

MOTHERWORT HERB DRY

A, H

 

3420

MOTHERWORT HERB POWDER

A, H

 

3421

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%.

 

3422

MULBERRY

E

 

3423

MUNG BEAN

E

 

3424

MURRAYA KOENIGII

A, H

 

3425

MURRAYA PANICULATA

A, H

 

3426

MUSA X PARADISIACA

A, H

 

3427

MUSK KETONE

E

Only for use in topical medicines for dermal application.

 

3428

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%.

 

3429

MUSK XYLOL

E

Only for use in topical medicines for dermal application.

 

3430

MUSKS

H

Only for use as an active homoeopathic ingredient. 

 

3431

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%.

 

3432

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%.

 

3433

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%.

 

3434

MYOSOTIS ARVENSIS

A, H

 

3435

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%.

 

3436

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%.

 

3437

MYRICA CERIFERA

A, E, H

 

3438

MYRISTIC ACID

E

 

3439

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%.

 

3440

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).

 

3441

MYRISTYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

3442

MYRISTYL LACTATE

E

Only for use in topical medicines for dermal application.

 

3443

MYRISTYL MYRISTATE

E

Only for use in topical medicines for dermal application.

 

3444

MYROXYLON BALSAMUM

A, E, H

 

3445

MYROXYLON BALSAMUM VAR. PEREIRAE

A, H

 

3446

MYRRH

A, H

 

3447

MYRRH OIL

A, E, H

 

3448

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%.

 

3449

MYRRHIS ODORATA

A, H

 

3450

MYRSINE AFRICANA

A, H

 

3451

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%.

 

3452

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%.

 

3453

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%.

 

3454

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%.

 

3455

MYRTUS COMMUNIS

A, E, H

 

3456

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.

 

3457

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%.

 

3458

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%.

 

3459

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%.

 

3460

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%.

 

3461

NAPHTHALENE

H

Only for use as an active homoeopathic ingredient. 

 

3462

NARDOSTACHYS CHINENSIS

A, H

 

3463

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%.

 

3464

NASTURTIUM OFFICINALE

A, E, H

 

3465

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.

 

3466

NAUCLEA OFFICINALIS

A, H

 

3467

NELUMBO NUCIFERA

A, H

 

3468

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%.

 

3469

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%

 

3470

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%.

 

3471

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%.

 

3472

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%. 

 

3473

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.

 

3474

NEOPENTYL GLYCOL DIOCTANOATE/DIDECANOATE

E

Only for use in topical medicines for dermal application.

 

3475

NEOPICRORHIZA SCROPHULARIIFLORA

A, H

 

3476

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%.

 

3477

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%.

 

3478

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%.

 

3479

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%.

 

3480

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%.

 

3481

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%.

 

3482

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%.

 

3483

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%.

 

3484

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%.

 

3485

NICKEL

H

Only for use as an active homoeopathic ingredient.

 

3486

NICOTIANA TABACUM

H

Only for use as an active homoeopathic ingredient.

 

3487

NICOTINAMIDE

A, E, H

 

3488

NICOTINAMIDE ASCORBATE

A, E

 

3489

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’.

 

3490

NICOTINIC ACID

A, E

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

 

3491

NIGELLA DAMASCENA

A, H

 

3492

NIGELLA SATIVA

A, E, H

 

3493

NITRIC ACID

E, H

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

 

3494

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%.

 

3495

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%.

 

3496

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%.

 

3497

NONFAT DRY MILK

E, H

 

3498

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%.

 

3499

NONOXINOL 10

E

Only for use in topical medicines for dermal application.

 

3500

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%.

 

3501

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%.

 

3502

NONOXINOL 9

E

Only for use in topical medicines for dermal application.

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

 

3503

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%.

 

3504

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%.

 

3505

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%.

 

3506

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%.

 

3507

NOTOPTERYGIUM FORBESII

A, H

 

3508

NOTOPTERYGIUM INCISIUM

A, H

 

3509

NUPHAR JAPONICA

A, H

 

3510

NUPHAR LUTEA

A, H

 

3511

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%.

 

3512

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).

 

3513

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%.

 

3514

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%.

 

3515

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%.

 

3516

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'.

 

3517

NYLON

E

Only for use in topical medicines for dermal application.

 

3518

NYLON 6/12

E

Only for use in topical medicines for dermal application.

 

3519

NYLON-12

E

Only for use in topical medicines for dermal application.

 

3520

NYMPHAEA ALBA

A, E, H

 

3521

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.

 

3522

NYMPHAEA ODORATA

A, H

 

3523

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%.

 

3524

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%.

 

3525

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.

 

3526

OAT BRAN

E

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

 

3527

OATMEAL COLLOIDAL

A, E

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

 

3528

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%.

 

3529

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%.

 

3530

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%.

 

3531

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.

 

3532

OCIMUM MINIMUM

A, H

 

3533

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%.

 

3534

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%.

 

3535

OCTACOSANOL

E

 

3536

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%.

 

3537

OCTADECENE/MA COPOLYMER

E

Only for use in topical medicines for dermal application.

 

3538

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%.

 

3539

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%.

 

3540

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%.

 

3541

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%.

 

3542

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%.

 

3543

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%.

 

3544

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%.

 

3545

OCTHILINONE

E

Only for use in topical medicines for dermal application.

 

3546

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).

 

3547

OCTOXINOL 10

E

Only for use in topical medicines for dermal application.

 

3548

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%.

 

3549

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.

 

3550

OCTYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

 

3551

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%.

 

3552

OCTYL ISONONANOATE

E

Only for use in topical medicines for dermal application.

 

3553

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).

 

3554

OCTYL PALMITATE

E

Only for use in topical medicines for dermal application.

 

3555

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).

 

3556

OCTYL STEARATE

E

Only for use in topical medicines for dermal application.

 

3557

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).

 

3558

OCTYLDODECANOL

E

Only for use in topical medicines for dermal application.

 

3559

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.

 

3560

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%.

 

3561

OCTYLDODECYL NEOPENTANOATE

E

Only for use in topical medicines for dermal application.

 

3562

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%.

 

3563

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%.

 

3564

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%.

 

3565

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.

 

3566

OENANTHE CROCATA

A, H

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

 

3567

OENOTHERA BIENNIS

A, E, H

 

3568

OENOTHERA STRICTA

A, H

 

3569

OKOUBAKA AUBREVILLEI

A, H

 

3570

OLDENLANDIA DIFFUSA

A, E, H

 

3571

OLEA EUROPAEA

A, E, H

 

3572

OLEIC ACID

E

 

3573

OLETH-10

E

Only for use in topical medicines for dermal application.

 

3574

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%.

 

3575

OLETH-20

E

Only for use in topical medicines for dermal application.

 

3576

OLETH-3

E

Only for use in topical medicines for dermal application.

 

3577

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%.

 

3578

OLETH-5

E

Only for use in topical medicines for dermal application.

 

3579

OLEYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

3580

OLIBANUM OIL

A, E, H

 

3581

OLIGOFRUCTOSE

A, E

 

3582

OLIVE

E

 

3583

OLIVE OIL

A, E, H

 

3584

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).'

 

3585

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 to be used in a medicine where DSM Nutritional Products Pty Ltd  (Client ID 31685), 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 30 June 2021.

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).

 

3586

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.'

 

3587

ONION

E

 

3588

ONION OIL

A, H

 

3589

ONONIS SPINOSA

A, E, H

 

3590

ONOPORDUM ACANTHIUM

A, H

 

3591

ONOSMODIUM VIRGINIANUM

A, H

 

3592

OPHIOPOGON JAPONICUS

A, H

 

3593

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%.

 

3594

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%.

 

3595

OPUNTIA FICUS-INDICA

A, H

 

3596

ORANGE

E

 

3597

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%.

 

3598

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.

 

3599

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%.

 

3600

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%.

 

3601

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.

 

3602

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.

 

3603

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.

 

3604

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%.

 

3605

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.

 

3606

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%.

 

3607

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.

 

3608

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%.

 

3609

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.

 

3610

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%.

 

3611

ORANGE ROUGHY OIL

E

Only for use in topical medicines for dermal application.

 

3612

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).

 

3613

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%.

 

3614

ORIGANUM OIL SPANISH

A, E, H

 

3615

ORIGANUM VULGARE

A, E, H

 

3616

ORNITHINE

A, E

 

3617

ORNITHINE ASPARTATE

A, E

 

3618

ORNITHINE MONOHYDROCHLORIDE

A, E

 

3619

ORNITHOGALUM UMBELLATUM

A, H

 

3620

OROSTACHYS FIMBRIATA

A, H

 

3621

OROXYLUM INDICUM

A, H

 

3622

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%.

 

3623

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%.

 

3624

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%.

 

3625

ORRIS ROOT OIL

A, E, H

 

3626

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%.

 

3627

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%.

 

3628

ORTHOSIPHON ARISTATUS

A, H

 

3629

ORYZA SATIVA

A, E, H

 

3630

ORYZANOL

E

 

3631

OSBECKIA CHINENSIS

A, H

 

3632

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%.

 

3633

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%.

 

3634

OTTELIA ALISMOIDES

A, H

 

3635

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%.

 

3636

OXACYCLOHEXADECAN-2-ONE

E

Only for use in topical medicines for dermal application.

 

3637

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%.

 

3638

OXALIC ACID

H

Only for use as an active homoeopathic ingredient. 

 

3639

OXALIS ACETOSELLA

A, H

 

3640

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%.

 

3641

OXIDISED TAPIOCA STARCH

E

 

3642

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).

 

3643

OYSTER

E

 

3644

OYSTER SHELL

A, E, H