Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient Name

Purpose

Specific requirements

2857

KADSURA COCCINEA

A, H

2858

KAEMPFERIA GALANGA

A, H

2859

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%.

2860

KAOLIN

E

2861

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.

2862

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.

2863

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%.

2864

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%. 

2865

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'.

2866

KIDNEY BEAN

E

2867

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%.

2868

KIWI FRUIT

E

2869

KNAUTIA ARVENSIS

A, H

2870

KOREAN GINSENG ROOT DRY

A, H

2871

KOREAN GINSENG ROOT POWDER

A, H

2872

KRAMERIA IXINE

A, H

2873

KRAMERIA LAPPACEA

A, H

2874

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'.

2875

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%.

2876

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%.

2877

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%.

2878

L-LIMONENE

E

L-limonene must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation or a fragrance proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing l-limonene must not be more than 5% of the total medicine.

The total concentration of fragrance proprietary excipient formulations containing l-limonene must not be more than 1% of the total medicine.

2879

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%.

2880

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%.

2881

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%.

2882

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%.

2883

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%.

2884

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%.

2885

LABDANUM OIL

A, E, H

2886

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%.

2887

LACTALBUMIN

E

2888

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.

2889

LACTITOL

E

2890

LACTITOL MONOHYDRATE

E

2891

LACTO-N-NEOTETRAOSE

A

Lactose is a mandatory component of lacto-N-neotetraose.

The route of administration for medicines that contain lacto-N-neotetraose must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than:

(a) 1.5 g of lacto-N-neotetraose to individuals aged 4 years and older; and

(b) 0.6 g of lacto-N-neotetraose to individuals aged up to 3 years (inclusive).

One of the following statements (or words to the same effect) is required on the medicine label:

(a) When the medicine is only for use in individuals aged 2 years and above: ‘Not to be taken on the same day with other products containing lacto-N-neotetraose'; or

(b) When the medicine is for use in children aged less than 2 years: ‘Not to be taken on the same day with breastmilk or other products containing lacto-N-neotetraose’.

2892

LACTO-N-TETRAOSE

A

Lactose is a mandatory component of lacto-N-tetraose.

The route of administration for medicines that contain lacto-N-tetraose must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than:

a) 2 g of lacto-N-tetraose to individuals aged 1 year and older; and

b) 0.6 g of lacto-N-tetraose to individuals aged more than 6 months to 11 months (inclusive); and

c) 0.8 g of lacto-N-tetraose to individuals aged up to 6 months (inclusive).

One of the following statements (or words to the same effect) is required on the medicine label:

a) When the medicine is only for use in individuals aged 2 years and above: 'Not to be taken on the same day with other products containing lacto-N-tetraose'; or

b) When the medicine is for use in children aged less than 2 years: 'Not to be taken on the same day with breastmilk or other products containing lacto-N-tetraose'.

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 following warning statement is required on the medicine label:

(CHAP1) 'In rare cases, Larrea tridentata may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine.'

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

When the total concentration of bay oil in the medicine is more than 25%:

(a) the nominal capacity of the container must not be more than 25 mL;

(b) the container must be fitted with a restricted flow insert;

(c) the following warning statements are required on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect);

- (NTAKEN) 'Not to be taken'; and

(d)  when the nominal capacity of the container is greater than 15 mL, the container must also be fitted with a child resistant closure.

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, and the concentration of bay oil or distillate in the medicine is greater than 25%:

(a) the nominal capacity of the container must not be more than 25 mL;

(b) the container must be fitted with a restricted flow insert;

(c) the following warning statements are required on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect);

- (NTAKEN) 'Not to be taken'; and

(d)  when the nominal capacity of the container is greater than 15 mL, the container must also be fitted with a child resistant closure.

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

The route of administration for medicines that contain Lepidium meyenii must be limited to oral.

The ingredient must consist of the dried tuber of Lepidium meyenii only.

The maximum recommended daily dose of the medicine must not provide more than 3.5 g of Lepidium meyenii dried tuber (or its extract equivalent).

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 oral application in a mouthwash, or topical.

If the concentration is more than 25%, the nominal capacity of the container must not be more than 25 millilitres.

When the concentration is more than 25%, and the nominal capacity of the container is less than or equal to 15 millilitres, a restricted flow insert must be fitted on the container and requires the following warning statements on the medicine label:

- (CHILD) ‘Keep out of reach of children' (or word to that effect); and

- (NTAKEN) ‘Not to be taken’.

When the concentration is more than 25%, and the nominal capacity of the container is more than 15 millilitres but not more than 25 millilitres, a child resistant closure and restricted flow insert must be fitted on the container and requires the following warning statements on the medicine label:

- (CHILD) ‘Keep out of reach of children' (or word to that effect); and

- (NTAKEN) ‘Not to be taken’.

3001

LESPEDEZA CAPITATA

A, H

3002

LETTUCE

E

3003

LEUCINE

A, E

3004

LEUZEA UNIFLORA

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

Magnesium is a mandatory component of light magnesium oxide.

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

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

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

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

Lime oil must only be included in medicines when in combination with other permitted ingredients as a flavour or a fragrance proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing lime oil must not be more than 5% of the total medicine.

The total concentration of fragrance proprietary excipient formulations containing lime oil must not be more than 1% of the total medicine.

When for other than internal use:

(a) the concentration of lime oil in the medicine must not be more than 0.5%; or

(b) the following warning statement (or words to the same effect) is required on the medicine label:

- (SENS) ‘Application to the skin may increase sensitivity to sunlight’.

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 OIL FATTY ACIDS

E

Linseed oil fatty acids must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing linseed oil fatty acids must not be more than 5% of the total medicine.

3053

LINSEED POWDER

A, E, H

3054

LINUM USITATISSIMUM

A, E, H

3055

LIPASE

A

Permitted for use only when derived from Rhizopus oryzae and in medicines containing 20,000 lipase units (equivalent to 20,000 BP units) or less of lipase activity per dosage unit.

Lipase must comply with the relevant compositional guideline.

3056

LIPPIA DULCIS

A, H

3057

LIQUID GLUCOSE

E

3058

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.

3059

LIQUIDAMBAR FORMOSANA

A, H

3060

LIQUIDAMBAR ORIENTALIS

A, H

3061

LIQUIDAMBAR STYRACIFLUA

A, E, H

3062

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%.

3063

LIQUIDAMBAR TAIWANIANA

A, H

3064

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%.

3065

LIQUORICE DRY

A, E, H

3066

LIQUORICE LIQUID EXTRACT

A, E, H

3067

LIQUORICE POWDER

A, E, H

3068

LITCHI CHINENSIS

A, E, H

When used as an excipient, Litchi chinensis must only be included in medicines when the plant part is fruit, in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing Litchi chinensis must not be more than 5% of the total medicine.

3069

LITHIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

3070

LITHOSPERMUM OFFICINALE

A, H

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

3071

LITSEA CUBEBA

A, E, H

3072

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%.

3073

LOBARIA PULMONARIA

A, H

3074

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.

3075

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.

3076

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.

3077

LOLIUM PERENNE

A, H

3078

LOLIUM TEMULENTUM

A, H

3079

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%.

3080

LONICERA CAPRIFOLIUM

A, E, H

3081

LONICERA JAPONICA

A, E, H

3082

LONICERA PERICLYMENUM

A, H

3083

LOPHATHERUM GRACILE

A, H

3084

LOQUAT

E

3085

LORANTHUS PARASITICUS

A, H

3086

LOROPETALUM CHINENSE

A, H

3087

LOTUS CORNICULATUS

A, H

3088

LOVAGE OIL

A, E, H

3089

LOVAGE ROOT DRY

A, H

3090

LOVAGE ROOT POWDER

A, H

3091

LUDWIGIA PROSTRATA

A, H

3092

LUFFA CYLINDRICA

A, H

3093

LUFFA PURGANS

A, H

3094

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.

3095

LYCHEE

E

3096

LYCIUM BARBARUM

A, H

3097

LYCIUM CHINENSE

A, E, H

3098

LYCOPENE

A, E

3099

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.

3100

LYCOPODIUM ANNOTINUM

A, H

3101

LYCOPODIUM CLAVATUM

A, H

3102

LYCOPODIUM COMPLANATUM

A, H

3103

LYCOPUS EUROPAEUS

A, H

3104

LYCOPUS LUCIDUS

A, H

3105

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%.

3106

LYGODIUM JAPONICUM

A, H

3107

LYSIMACHIA CHRISTINAE

A, H

3108

LYSIMACHIA VULGARIS

A, H

3109

LYSINE

A, E

3110

LYSINE HYDROCHLORIDE

A, E

3111

LYTHRUM HYSSOPIFOLIA

A, H

3112

LYTHRUM SALICARIA

A, H

3113

LYTHRUM VERTICILLATUM

A, H

3114

MACADAMIA INTEGRIFOLIA

A, 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.

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

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

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

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

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

3150

MAGNESIUM CHLORIDE HEXAHYDRATE

A, E, H

Magnesium is a mandatory component of magnesium chloride hexahydrate.

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

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

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

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

Magnesium is a mandatory component of magnesium hydrogen phosphate.

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

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

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

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.

Magnesium is a mandatory component of magnesium hydroxide.

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

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

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

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

Magnesium is a mandatory component of magnesium oxide.

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

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

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

3167

MAGNESIUM PHOSPHATE PENTAHYDRATE

A, E, H

Magnesium is a mandatory component of magnesium phosphate pentahydrate.

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

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

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

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.

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

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

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

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.

Magnesium is a mandatory component of magnesium sulfate dihydrate.

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

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

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

3172

MAGNESIUM SULFATE HEPTAHYDRATE

A, E, H

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

Magnesium is a mandatory component of magnesium sulfate heptahydrate.

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

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

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

3173

MAGNESIUM SULFATE MONOHYDRATE

A, E, H

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

Magnesium is a mandatory component of magnesium sulfate monohydrate.

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

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

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

3174

MAGNESIUM SULFATE TRIHYDRATE

A, E, H

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

Magnesium is a mandatory component of magnesium sulfate trihydrate.

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

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

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

3175

MAGNESIUM TRISILICATE

E

Magnesium is a mandatory component of magnesium trisilicate.

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

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

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

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 OIL

A, E, H

3182

MAIZE STARCH

A, E, H

3183

MALACHITE GREEN

E

Permitted for use only as a colour for topical use.

3184

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.

3185

MALPIGHIA GLABRA

A, E, H

3186

MALT EXTRACT

E

3187

MALTITOL

E

3188

MALTITOL SOLUTION

E

3189

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.

3190

MALTOL

E

3191

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%.

3192

MALTOSE

E

3193

MALUS DOMESTICA

A, E, H

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

3194

MALUS SYLVESTRIS

A, H

3195

MALVA MOSCHATA

A, H

3196

MALVA SYLVESTRIS

A, E, H

3197

MALVA VERTICILLATA

A, H

3198

MANDARIN

E

3199

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%.

3200

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.

3201

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%.

3202

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%.

3203

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%.

3204

MANGANESE

H

Only for use as an active homoeopathic ingredient.

3205

MANGANESE (II) DIASPARTATE

A, H

Only for use in oral medicines.

3206

MANGANESE (II) GLYCINATE

A, H

Only for use in oral medicines.

3207

MANGANESE ACETATE TETRAHYDRATE

H

Only for use as an active homoeopathic ingredient. 

3208

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.

3209

MANGANESE CHLORIDE TETRAHYDRATE

A, E, H

3210

MANGANESE DIASPARTATE

A, E, H

Only for use in oral medicines.

3211

MANGANESE GLUCONATE

A, E, H

3212

MANGANESE GLYCEROPHOSPHATE

A, E, H

3213

MANGANESE OXIDE

A, E, H

3214

MANGANESE SULFATE MONOHYDRATE

A, E, H

3215

MANGANESE SULFATE TETRAHYDRATE

A, E, H

3216

MANGIFERA INDICA

A, E, H

3217

MANGO

E, H

3218

MANIHOT ESCULENTA

A, H

3219

MANNITOL

E

3220

MARANTA ARUNDINACEA

A, H

3221

MARINE SPONGE

H

Only for use as an active homoeopathic ingredient.

3222

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).

3223

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).

3224

MARRUBIUM VULGARE

A, E, H

3225

MARSDENIA CUNDURANGO

A, H

3226

MARSHMALLOW ROOT DRY

A, H

3227

MARSHMALLOW ROOT POWDER

A, H

3228

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%.

3229

MASTIC

A, H

3230

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%.

3231

MATRICARIA CHAMOMILLA

A, E, H

3232

MATRICARIA FLOWER DRY

A, E, H

3233

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'.

3234

MECOBALAMIN

A

Only for use in oral medicines.

3235

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.

3236

MEDIUM CHAIN TRIGLYCERIDES

E

3237

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.

3238

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.

3239

MELALEUCA CITRINA

A, H

3240

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.

3241

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.

3242

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.

3243

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.

3244

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.

3245

MELICOPE PTELEIFOLIA

A, H

3246

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%.

3247

MELISSA OFFICINALIS

A, E, H

3248

MELON

E

3249

MENADIONE SODIUM BISULFITE

E

3250

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.

3251

MENISPERMUM CANADENSE

A, H

3252

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.

3253

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.

3254

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.

3255

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.

3256

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.

3257

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.

3258

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.

3259

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.

3260

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.

3261

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.

3262

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%.

3263

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%.

3264

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.

3265

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%.

3266

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%.

3267

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%.

3268

MENTHOXYPROPANEDIOL

E

For oral use only.

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

3269

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%.

3270

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%.

3271

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).

3272

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%.

3273

MENTHYL LACTATE

E

3274

MENYANTHES TRIFOLIATA

A, H

3275

MERCURIC CHLORIDE

H

Only for use as an active homoeopathic ingredient.

Mercury is a mandatory component of mercuric chloride.

The total concentration of mercury in the medicine must not be more than 1 mg/kg or 1 mg/L or 0.0001%.

3276

MERCURY

H

Only for use as an active homoeopathic ingredient.

The total concentration of mercury in the medicine must not be more than 1 mg/kg or 1 mg/L or 0.0001%.

3277

METACRESOL

E

Only for use in topical medicines for dermal application.

3278

METHACRYLIC ACID COPOLYMER

E

Only for use in oral medicines.

3279

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%.

3280

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%.

3281

METHIONINE

A, E

3282

METHOXYPROPYLAMINO CYCLOHEXENYLIDENE ETHOXYETHYLCYANOACETATE

A

Until 20 June 2027, Methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate must only be used in a medicine where:

(a) BASF Australia Ltd (Client ID 13479) is the sponsor of the medicine (the primary sponsor); or

(b) another person is the sponsor of the medicine (the secondary sponsor) and the TGA has been notified that the secondary sponsor has been authorised by the primary sponsor to use the ingredient in the medicine.

Methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate must:

(a) only be used as an active ingredient in sunscreens in topical medicines for dermal application; and

(b) not be included in medicines that are intended for use on:

   (i) the eye; or

   (ii) broken skin.

The total concentration of methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate the medicine must not be more than 3%.

Methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate must not be used in combination with nitrosating substances.

The concentration of nitrosamine in the medicine must be less than 0.000005% or 50 ppb.

When used in primary sunscreen products, the following warning statements (or words to the same effect) must be included on the medicine label:

- (AVOID) ' Avoid prolonged exposure in the sun.';

- (SUNPRO) ' Wear protective clothing - hats and eyewear when exposed to the sun.'.

3283

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%.

3284

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%.

3285

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%.

3286

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%.

3287

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%.

3288

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%.

3289

METHYL ACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

3290

METHYL ACRYLATE, METHYL METHACRYLATE AND METHACRYLIC ACID COPOLYMER DISPERSION (30 PER CENT)

E

Methyl methacrylate is a mandatory component of methyl acrylate, methyl methacrylate and methacrylic acid copolymer dispersion (30 per cent).

The total concentration of methyl methacrylate as residual monomer in the medicine must not be more than 1%.

The route of administration for medicines that contain methyl acrylate, methyl methacrylate and methacrylic acid copolymer dispersion (30 per cent) must be limited to oral use.

Methyl acrylate, methyl methacrylate and methacrylic acid copolymer dispersion (30 per cent) is not permitted for use in children under the age of 4 years.

The maximum recommended daily dose of the medicine must not provide more than:

(a) 667 milligrams of methyl acrylate, methyl methacrylate and methacrylic acid copolymer dispersion (30 per cent) to individuals aged 4 to 17 years (inclusive); and

(b) 2.33 grams of methyl acrylate, methyl methacrylate and methacrylic acid copolymer dispersion (30 per cent) to individuals aged 18 years and above.

3291

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%.

3292

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%.

3293

METHYL BENZOATE

E

Only for use in topical medicines for dermal application.

3294

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%.

3295

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%.

3296

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%.

3297

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%.

3298

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%.

3299

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%.

3300

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%.

3301

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%.

3302

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%.

3303

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%.

3304

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%.

3305

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%.

3306

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%.

3307

METHYL ETHER

E

Only for use in topical medicines for dermal application.

3308

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%.

3309

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%.

3310

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%.

3311

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.

3312

METHYL GLUCETH-20

E

Only for use in topical medicines for dermal application.

3313

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%.

3314

METHYL GLUCETH-20 SESQUIHYDRATE

E

Only for use in topical medicines for dermal application.

3315

METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

3316

METHYL GLUCOSE SESQUIOLEATE

E

Only for use in topical medicines for dermal application.

3317

METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

3318

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%.

3319

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%.

3320

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%.

3321

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%.

3322

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%.

3323

METHYL HYDROGENATED ROSINATE

E

Only for use in topical medicines for dermal application.

3324

METHYL HYDROJASMONATE

E

The route(s) of administration for medicines that contain methyl hydrojasmonate must be limited to:

(a) topical for dermal use; and

(b) oral.

When used in oral medicines:

(a) methyl hydrojasmonate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation; and

(b) the total concentration of flavour proprietary excipient formulations containing methyl hydrojasmonate must not be more than 5% of the total medicine.

3325

METHYL HYDROXYBENZOATE

E

3326

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%.

3327

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%.

3328

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%.

3329

METHYL ISOVALERATE