2813

KADSURA COCCINEA

A, H

2814

KAEMPFERIA GALANGA

A, H

2815

KALMIA LATIFOLIA

A, H

2816

KAOLIN

E

2817

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.

2818

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.

2819

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%.

2820

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%. 

2821

KIDNEY BEAN

E

2822

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%.

2823

KIWI FRUIT

E

2824

KNAUTIA ARVENSIS

A, H

2825

KOREAN GINSENG ROOT DRY

A, H

2826

KOREAN GINSENG ROOT POWDER

A, H

2827

KRAMERIA IXIENA

A, H

2828

KRAMERIA LAPPACEA

A, H

2829

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'.

2830

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%.

2831

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%.

2832

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%.

2833

L-LIMONENE

E

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

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

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

2834

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%.

2835

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%.

2836

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%.

2837

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%.

2838

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%.

2839

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%.

2840

LABDANUM OIL

A, E, H

2841

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%.

2842

LACTALBUMIN

E

2843

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.

2844

LACTITOL

E

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

- (SUGOLS) 'Medicines containing lactitol may have a laxative effect or cause diarrhoea' (or words to that effect);

- (LACT) 'Contains lactose' (or words to that effect); and

- (COWMK) 'Derived from cows milk'.

2845

LACTITOL MONOHYDRATE

E

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

- (SUGOLS) 'Medicines containing lactitol monohydrate may have a laxative effect or cause diarrhoea' (or words to that effect)

- (LACT) 'Contains lactose' (or words to that effect)

- (COWMK) 'Derived from cows milk'.

2846

LACTOBACILLUS ACIDOPHILUS

A

2847

LACTOBACILLUS AMYLOVORUS

A

2848

LACTOBACILLUS BREVIS

A

2849

LACTOBACILLUS CASEI

A

2850

LACTOBACILLUS CASEI SUBSP. BIOVAR CASEI

A

2851

LACTOBACILLUS CRISPATUS

A

2852

LACTOBACILLUS DELBRUECKII SSP BULGARICUS

A

2853

LACTOBACILLUS DELBRUECKII SSP LACTIS

A

2854

LACTOBACILLUS FERMENTUM

A

2855

LACTOBACILLUS GALLINARUM

A

2856

LACTOBACILLUS GASSERI

A

2857

LACTOBACILLUS HELVETICUS

A

2858

LACTOBACILLUS JOHNSONII

A

2859

LACTOBACILLUS KEFIRANOFACIENS

A

2860

LACTOBACILLUS KEFIRGRANUM

A

2861

LACTOBACILLUS KEFIRI

A

2862

LACTOBACILLUS PARACASEI

A

2863

LACTOBACILLUS PARACASEI SUBSP. PARACASEI

A

2864

LACTOBACILLUS PLANTARUM

A

2865

LACTOBACILLUS REUTERI

A

2866

LACTOBACILLUS RHAMNOSUS

A

2867

LACTOBACILLUS SALIVARIUS SSP SALICINIUS

A

2868

LACTOBACILLUS SALIVARIUS SSP SALIVARIUS

A

2869

LACTOBIONIC ACID

E

Only for use in topical medicines for dermal application.

2870

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%.

2871

LACTOSE

E

When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label:

- (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars [or words to that effect]’ if medicine contains two or more sugars.

If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label:

- (LACT) ‘Contains lactose [or words to that effect]’.

2872

LACTOSE MONOHYDRATE

E

When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose monohydrate, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label:

- (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars [or words to that effect]’ if medicine contains two or more sugars.

If one of the sugars is lactose monohydrate then the medicine also requires the following warning statement on the medicine label:

- (LACT) ‘Contains lactose monohydrate [or words to that effect]’.

2873

LACTUCA SATIVA

A, H

2874

LACTUCA VIROSA

A, H

2875

LACTULOSE

E

2876

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.

2877

LAGENARIA VULGARIS

A, H

2878

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.

2879

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.

2880

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.

2881

LAMIUM ALBUM

A, H

2882

LANETH-5

E

Only for use in topical medicines for dermal application.

2883

LANOLIN ALCOHOL

E

Only for use in topical medicines for dermal application.

2884

LANOLIN OIL

E

Only for use in topical medicines for dermal application.

2885

LANOLIN WAX

E

Only for use in topical medicines for dermal application.

2886

LANTANA CAMARA

A, H

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

2887

LARIX ARABINOGALACTAN

A, E

Only for use in oral medicines.

The ingredient must be derived from Larix occidentalis or Larix larcinia.

The maximum recommended daily dose must be no more than 15 grams.

The concentration of polysaccharides in the medicine must be equal to or more than 85%.

2888

LARIX DECIDUA

A, H

2889

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.

2890

LARREA TRIDENTATA

A, H

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

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

2891

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.

2892

LAURAMINE OXIDE

E

2893

LAUREL LEAF OIL

A, H

2894

LAURETH-10

E

Only for use in topical medicines for dermal application.

2895

LAURETH-12

E

Only for use in topical medicines for dermal application.

2896

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.

2897

LAURETH-23

E

Only for use in topical medicines for dermal application.

2898

LAURETH-3

E

Only for use in topical medicines for dermal application.

2899

LAURETH-4

E

Only for use in topical medicines for dermal application.

2900

LAURETH-7

E

Only for use in topical medicines for dermal application.

2901

LAURETH-8

E

2902

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.

2903

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%.

2904

LAUROMACROGOL 400

E

Only for use in topical medicines for dermal application.

2905

LAUROYL LYSINE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.75%.

2906

LAURUS NOBILIS

A, E, H

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

When the concentration of Laurus nobilis oil or distillate in the preparation is greater than 25% and the nominal capacity of the container is less than or equal to 15 millilitres, a restricted flow insert must be fitted on the container.

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

When the concentration of Laurus nobilis oil or distillate in the preparation is greater than 25%, the medicine must include the following warning statements on the medicine label:

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

- (NTAKEN) 'Not to be taken'.

2907

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%.

2908

LAURYL BETAINE

E

Only for use in topical medicines for dermal application.

2909

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%.

2910

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.

2911

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%.

2912

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%.

2913

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.

The concentration in the medicine must be no more than 2.5%.

2914

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.

2915

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.

2916

LAURYL PYRROLIDONE

E

Only for use in topical medicines for dermal application.

2917

LAURYLDIMONIUM HYDROXYPROPYL HYDROLYSED COLLAGEN

E

Only for use in topical medicines for dermal application.

2918

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%.

2919

LAURYLMETICONE COPOLYOL

E

Only for use in topical medicines for dermal application.

2920

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%.

2921

LAVANDIN OIL ABRIAL

A, E, H

2922

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%.

2923

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

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

In essential oil or distillate preparations when the concentration of camphor is more than 2.5%, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

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

- (NTAKEN) 'Not to be taken'.

In essential oil or distillate preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must also have a child resistant closure fitted on the container.

If the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25 millilitres.

2924

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

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

In essential oil or distillate preparations when the concentration of camphor is more than 2.5%, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'.

In essential oil or distillate preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must also have a child resistant closure fitted on the container.

2925

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%.

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

If the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25 millilitres.

2926

LAVENDER OIL

A, E, H

Camphor is a mandatory component of lavender oil.

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

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

In essential oil preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

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

- (NTAKEN) 'Not to be taken'.

In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

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

- (NTAKEN) 'Not to be taken'.

In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label:

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

- (NTAKEN) 'Not to be taken'.

If the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25 millilitres.

2927

LAWSONIA INERMIS

A, H

2928

LEAD

H

Only for use as an active homoeopathic ingredient.

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

2929

LEAD ACETATE

H

Only for use as an active homoeopathic ingredient.

2930

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%.

2931

LECITHIN

A, E

2932

LEDEBOURIELLA SESELOIDES

A, H

2933

LEDUM GROENLANDICUM

A, H

2934

LEDUM PALUSTRE

A, H

When the route of administration is other than topical, the maximum recommended daily dose must be no more than 0.001mg of the equivalent dry herbal material of Ledum palustre.

2935

LEMNA MINOR

A, H

2936

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.

2937

LEMON BALM LEAF DRY

A, H

2938

LEMON BALM LEAF POWDER

A, E, H

2939

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.

2940

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.

2941

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.

2942

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%.

2943

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.

2944

LEMONGRASS OIL

A, E, H

2945

LENS CULINARIS

A, H

2946

LENTIL

E

2947

LENTINULA EDODES

A, E, H

2948

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%.

2949

LEONURUS CARDIACA

A, E, H

2950

LEONURUS SIBIRICUS

A, E, H

2951

LEPIDIUM APETALUM

A, H

2952

LEPIDIUM MEYENII

A

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

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

2953

LEPTOSPERMUM PETERSONII

E

Only for use in topical medicines for dermal application.

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

2954

LEPTOSPERMUM SCOPARIUM OIL

A

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

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

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

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

- (NTAKEN) ‘Not to be taken’

When the concentration is more than 25%, the nominal capacity of the container is more than 15 mL but no more than 25 mL, a child resistant closure and restricted flow insert  must be fitted on the container and requires the following warning statements on the medicine label:

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

- (NTAKEN) ‘Not to be taken’

2955

LESPEDEZA CAPITATA

A, H

2956

LETTUCE

E

2957

LEUCINE

A, E

2958

LEUZEA UNIFLORUM

A, H

2959

LEVISTICUM OFFICINALE

A, H

2960

LEVOCARNITINE

A

2961

LEVOCARNITINE FUMARATE

A

2962

LEVOCARNITINE HYDROCHLORIDE

A

2963

LEVOCARNITINE MAGNESIUM CITRATE

A

2964

LEVOCARNITINE TARTRATE

A

2965

LEVOMEFOLATE CALCIUM

A

Only for use in oral medicines.

Levomefolic acid is a mandatory component of Levomefolate calcium.

The maximum recommended daily dose must provide no more than 500 micrograms of Levomefolic acid from Levomefolate calcium.

When folic acid, folinic acid, levomefolate salts and/or their derivatives are used in combination, the medicine must provide no more than a total of 500 micrograms of folic acid, folinic acid, levomefolate salts and/or their derivatives in total per maximum recommended daily dose.

When used in preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects:

a) the maximum daily dose must provide 400 – 500 micrograms of folic acid; and

b) the following statement must be included on the label: - (NEUR) 'Warning: Do not exceed the stated dose except on medical advice. If you have had a baby with a neural tube defect/spina bifida - seek specific medical advice (or words to that effect)’.

2966

LEVOMEFOLATE GLUCOSAMINE

A

Only for use in oral medicines.

Levomefolic acid is a mandatory component of levomefolate glucosamine.

The maximum recommended daily dose must provide no more than 500

micrograms of levomefolic acid from levomefolate glucosamine. 

When used in combination with folic acid, folinic acid and/or their derivatives, the medicine must not provide more than a total of 500 micrograms of folic acid, folinic acid and/or their derivatives in total per maximum recommended daily dose. When used in preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects:

a) the maximum daily dose must provide 400-500 micrograms of folic acid; and

b) the following statement must be included on the label:

- (NEUR) 'Warning: Do not exceed the stated dose except on medical advice. If you have had a baby with a neural tube defect/spina bifida - seek specific medical advice (or words to that effect).'

2967

LEVOTHYROXINE SODIUM

H

Only for use as an active homoeopathic ingredient.

2968

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%.

2969

LIGHT KAOLIN

E

2970

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.

2971

LIGHT MAGNESIUM OXIDE

A, E, H

2972

LIGUSTICUM SINENSE

A, H

2973

LIGUSTICUM STRIATUM

A, E, H

2974

LIGUSTRUM LUCIDUM

A, H

2975

LILIUM BROWNII

A, H

2976

LILIUM CANDIDUM

A, E, H

2977

LILIUM LANCIFOLIUM

A, H

2978

LILIUM LONGIFLORUM

A, H

2979

LIME FRUIT

E

2980

LIME OIL

E

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

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

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

2981

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.

2982

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.

2983

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%.

2984

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%.

2985

LIME TREE FLOWER DRY

A, H

2986

LIME TREE FLOWER POWDER

A, H

2987

LIME, ESSENCE

E

2988

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%.

2989

LIMONENE

E

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

2990

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%.

2991

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%.

2992

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%.

2993

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%.

2994

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%.

2995

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%.

2996

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%.

2997

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%.

2998

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%.

2999

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%.

3000

LINDERA STRYCHNIFOLIA

A, H

3001

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%.

3002

LINOLEIC ACID

E

3003

LINOLENIC ACID

E

3004

LINSEED DRY

A, E, H

3005

LINSEED OIL

A, E, H

3006

LINSEED POWDER

A, E, H

3007

LINUM USITATISSIMUM

A, E, H

3008

LIPASE

A

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

When used in an undivided preparation, the unit 'Thousand lipase units per gram' is permitted.

When used in a divided preparation, the unit 'Thousand lipase unit' is permitted.

3009

LIPPIA DULCIS

A, H

3010

LIQUID GLUCOSE

E

When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label:

- (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars.

If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label:

- (LACT) ‘Contains lactose' (or words to that effect).

3011

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.

3012

LIQUIDAMBAR FORMOSANA

A, H

3013

LIQUIDAMBAR ORIENTALIS

A, H

3014

LIQUIDAMBAR STYRACIFLUA

A, E, H

3015

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%.

3016

LIQUIDAMBAR TAIWANIANA

A, H

3017

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%.

3018

LIQUORICE DRY

A, E, H

3019

LIQUORICE LIQUID EXTRACT

A, E, H

3020

LIQUORICE POWDER

A, E, H

3021

LITCHI CHINENSIS

A, H

3022

LITHIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

3023

LITHOSPERMUM OFFICINALE

A, H

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

3024

LITSEA CUBEBA

A, E, H

3025

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%.

3026

LOBARIA PULMONARIA

A, H

3027

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.

3028

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.

3029

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.

3030

LOLIUM PERENNE

A, H

3031

LOLIUM TEMULENTUM

A, H

3032

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%.

3033

LONICERA CAPRIFOLIUM

A, E, H

3034

LONICERA JAPONICA

A, E, H

3035

LONICERA PERICLYMENUM

A, H

3036

LOPHATHERUM GRACILE

A, H

3037

LOQUAT

E

3038

LORANTHUS PARASITICUS

A, H

3039

LOROPETALUM CHINENSIS

A, H

3040

LOTUS CORNICULATUS

A, H

3041

LOVAGE EXTRACT

E

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

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

3042

LOVAGE OIL

A, E, H

3043

LOVAGE ROOT DRY

A, H

3044

LOVAGE ROOT POWDER

A, H

3045

LUDWIGIA PROSTRATA

A, H

3046

LUFFA CYLINDRICA

A, H

3047

LUFFA PURGANS

A, H

3048

LUTEIN

A, E, H

When used as an excipient, permitted for use as a colour for oral and topical use.

3049

LYCHEE

E

3050

LYCIUM BARBARUM

A, H

3051

LYCIUM CHINENSE

A, E, H

3052

LYCOPENE

A, E

3053

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.

3054

LYCOPODIUM ANNOTINUM

A, H

3055

LYCOPODIUM CLAVATUM

A, H

3056

LYCOPODIUM COMPLANATUM

A, H

3057

LYCOPUS EUROPAEUS

A, H

3058

LYCOPUS LUCIDUS

A, H

3059

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%.

3060

LYGODIUM JAPONICUM

A, H

3061

LYSIMACHIA CHRISTINAE

A, H

3062

LYSIMACHIA VULGARIS

A, H

3063

LYSINE

A, E

3064

LYSINE HYDROCHLORIDE

A, E

3065

LYTHRUM HYSSOPIFOLIA

A, H

3066

LYTHRUM SALICARIA

A, H

3067

LYTHRUM VERTICILLATUM

A, H

3068

MACADAMIA INTEGRIFOLIA

A, E

3069

MACADAMIA NUT

E

3070

MACADAMIA NUT OIL

E

3071

MACADAMIA TERNIFOLIA

A, E, H

3072

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%.

3073

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.

3074

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.

3075

MACROGOL 1000

E

3076

MACROGOL 1450

E

Only for use in topical medicines for dermal application.

3077

MACROGOL 1500

E

3078

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%.

3079

MACROGOL 200

E

Only for use in topical medicines for dermal application.

3080

MACROGOL 20000

E

3081

MACROGOL 300

E

3082

MACROGOL 3000

E

3083

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.

3084

MACROGOL 40

E

Only for use in topical medicines for dermal application.

3085

MACROGOL 400

E

3086

MACROGOL 4000

E

3087

MACROGOL 45000

E

Only for use in topical medicines for dermal application.

3088

MACROGOL 600

E

3089

MACROGOL 6000

E

3090

MACROGOL 600000

E

3091

MACROGOL 800

E

3092

MACROGOL 8000

E

3093

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%.

3094

MACROGOL POLY(VINYL ALCOHOL) GRAFTED POLYMER

E

Only for use in oral medicines.

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

3095

MACROPIPER EXCELSUM VAR EXCELSUM

A, H

3096

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.

3097

MAGNESIUM ASCORBATE

A, E, H

3098

MAGNESIUM ASCORBATE MONOHYDRATE

A, E, H

3099

MAGNESIUM ASCORBYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

3100

MAGNESIUM ASPARTATE

A, E, H

3101

MAGNESIUM ASPARTATE DIHYDRATE

A, E, H

3102

MAGNESIUM ASPARTATE TETRAHYDRATE

A, E, H

3103

MAGNESIUM CARBONATE HYDRATE

A, E, H

3104

MAGNESIUM CHLORIDE 4.5-HYDRATE

A

3105

MAGNESIUM CHLORIDE HEXAHYDRATE

A, E, H

3106

MAGNESIUM CITRATE

A, E, H

3107

MAGNESIUM CITRATE NONAHYDRATE

A, E, H

3108

MAGNESIUM CITRATE TETRADECAHYDRATE

A, E, H

3109

MAGNESIUM DIGLUTAMATE

A, E, H

3110

MAGNESIUM GLUCONATE

A, E, H

3111

MAGNESIUM GLYCEROPHOSPHATE

A, E, H

3112

MAGNESIUM GLYCINATE

A

Only for use in oral medicines.

3113

MAGNESIUM GLYCINATE DIHYDRATE

A

Only for use in oral medicines.

The purpose for use for all metal amino acid chelates is restricted to mineral supplementation.

Magnesium is a mandatory component of Magnesium glycinate dihydrate.

Based on molecular weights the declared quantity of Magnesium from Magnesium glycinate dihydrate must be no less than 11.1% and must be no more than 12.2% of the Magnesium glycinate dihydrate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations.

3114

MAGNESIUM HYDROGEN PHOSPHATE

H

3115

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.

When the medicine is not promoted or marketed as laxative, contains more than 2 g magnesium hydroxide per maximum recommended daily dose and the medicine is listed in the Register on or after 1 October 2017 the medicine must have the following statements on the medicine label:

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

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

When the medicine is not promoted or marketed as laxative, contains more than 2 g magnesium hydroxide per maximum recommended daily dose and the medicine is listed in the Register before 1 October 2017 the medicine requires the following statements on the medicine label if supplied after 1 April 2019:

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

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

3116

MAGNESIUM LYSINATE

A

Only for use in oral medicines.

3117

MAGNESIUM METHIONINATE

A

Only for use in oral medicines.

3118

MAGNESIUM NITRATE

E

Only for use in topical medicines for dermal application.

3119

MAGNESIUM OROTATE

A, E, H

3120

MAGNESIUM OROTATE DIHYDRATE

A, E, H

3121

MAGNESIUM OXIDE

A, E, H

3122

MAGNESIUM PHOSPHATE PENTAHYDRATE

A, E, H

3123

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.

3124

MAGNESIUM PYRUVATE

A

Only for use in oral medicines.

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

3125

MAGNESIUM STEARATE

E

3126

MAGNESIUM SULFATE DIHYDRATE

A, E, H

When used internally, the maximum recommended daily dose must be no more than 1.5g.

3127

MAGNESIUM SULFATE HEPTAHYDRATE

A, E, H

When used internally, the maximum recommended daily dose must be no more than 1.5g.

3128

MAGNESIUM SULFATE MONOHYDRATE

A, E, H

When used internally, the maximum recommended daily dose must be no more than 1.5g.

3129

MAGNESIUM SULFATE TRIHYDRATE

A, E, H

When used internally, the maximum recommended daily dose must be no more than 1.5g.

3130

MAGNESIUM TRISILICATE

E

3131

MAGNOLIA GLAUCA

A, H

3132

MAGNOLIA LILIFLORA

A, H

3133

MAGNOLIA OBOVATA

A, H

3134

MAGNOLIA OFFICINALIS

A, E, H

3135

MAGNOLIA SALICIFOLIA

A, H

3136

MAIZE

E

3137

MAIZE BRAN

E

3138

MAIZE OIL

A, E, H

3139

MAIZE STARCH

A, E, H

3140

MALACHITE GREEN

E

Permitted for use only as a colour for topical use.

3141

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.

3142

MALPIGHIA GLABRA

A, E, H

3143

MALT EXTRACT

E

3144

MALTITOL

E

When the quantity of sugar alcohols per maximum recommended daily dose is more than 2g, the quantity of the sugar alcohols must be declared on the label and the medicine requires the following warning statement on the medicine label:

- (SUGOLS) ‘Products containing [insert name of sugar alcohol(s) may have a laxative effect or cause diarrhoea [or words to that effect]’.

3145

MALTITOL SOLUTION

E

When the quantity of sugar alcohols per maximum recommended daily dose is more than 2g, the quantity of the sugar alcohols must be declared on the label and the medicine requires the following warning statement on the medicine label:

- (SUGOLS) ‘Products containing [insert name of sugar alcohol(s)] may have a laxative effect or cause diarrhoea' (or words to that effect).

3146

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.

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).

3147

MALTOL

E

3148

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%.

3149

MALTOSE

E

When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label:

- (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars.

If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label:

- (LACT) ‘Contains lactose' (or words to that effect).

3150

MALUS DOMESTICA

A, E, H

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

3151

MALUS PUMILA

A, E, H

3152

MALUS SYLVESTRIS

A, H

3153

MALVA MOSCHATA

A, H

3154

MALVA SYLVESTRIS

A, E, H

3155

MALVA VERTICILLATA

A, H

3156

MANDARIN

E

3157

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%.

3158

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.

3159

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%.

3160

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%.

3161

MANDARINAL 32048

E

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

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

3162

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%.

3163

MANGANESE

H

Only for use as an active homoeopathic ingredient.

3164

MANGANESE (II) DIASPARTATE

A, H

Only for use in oral medicines.

3165

MANGANESE (II) GLYCINATE

A, H

Only for use in oral medicines.

3166

MANGANESE ACETATE TETRAHYDRATE

H

Only for use as an active homoeopathic ingredient. 

3167

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.

3168

MANGANESE CHLORIDE TETRAHYDRATE

A, E, H

3169

MANGANESE DIASPARTATE

A, E, H

Only for use in oral medicines.

3170

MANGANESE GLUCONATE

A, E, H

3171

MANGANESE GLYCEROPHOSPHATE

A, E, H

3172

MANGANESE OXIDE

A, E, H

3173

MANGANESE SULFATE MONOHYDRATE

A, E, H

3174

MANGANESE SULFATE TETRAHYDRATE

A, E, H

3175

MANGIFERA INDICA

A, E, H

3176

MANGO

E, H

3177

MANIHOT ESCULENTA

A, H

3178

MANNITOL

E

When the quantity of sugar alcohols per maximum recommended daily dose is more than 2g, the quantity of the sugar alcohols must be declared on the label and the medicine requires the following warning statement on the medicine label:

- (SUGOLS) ‘Products containing [insert name of sugar alcohol(s)] may have a laxative effect or cause diarrhoea' (or words to that effect).

3179

MARANTA ARUNDINACEA

A, H

3180

MARINE SPONGE

H

Only for use as an active homoeopathic ingredient.

3181

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).

3182

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).

3183

MARRUBIUM VULGARE

A, E, H

3184

MARSDENIA CUNDURANGO

A, H

3185

MARSHMALLOW ROOT DRY

A, H

3186

MARSHMALLOW ROOT POWDER

A, H

3187

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%.

3188

MASTIC

A, H

3189

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%.

3190

MATRICARIA CHAMOMILLA

A, E, H

3191

MATRICARIA FLOWER DRY

A, E, H

3192

MEADOWSWEET HERB DRY

A, H

Methyl salicylate is a mandatory component of Meadowsweet herb dry.

Not to be used orally, unless the concentration of methyl salicylate in the medicine is no more than 0.001%.

When the concentration of methyl salicylate in the medicine is more than 0.001%, 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.

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 but the delivery device must be 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.

3193

MEADOWSWEET HERB POWDER

A, H

Methyl salicylate is a mandatory component of Meadowsweet herb powder.

Not to be used orally, unless the concentration of methyl salicylate in the medicine is no more than 0.001%.

When the concentration of methyl salicylate in the medicine is more than 0.001%, 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.

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 but the delivery device must be 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.

3194

MECOBALAMIN (CO-METHYLCOBALAMIN)

A

Only for use in oral medicines.

3195

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.

3196

MEDIUM CHAIN TRIGLYCERIDES

E

3197

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.

3198

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.

3199

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.

3200

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.

3201

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.

3202

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.

3203

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.

3204

MELICOPE PTELEIFOLIA

A, H

3205

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%.

3206

MELISSA OFFICINALIS

A, E, H

3207

MELON

E

3208

MENADIONE SODIUM BISULFITE

E

3209

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.

3210

MENISPERMUM CANADENSE

A, H

3211

MENTHA AQUATICA

A, H

3212

MENTHA ARVENSIS

A, E, H

3213

MENTHA ARVENSIS LEAF OIL

E

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

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

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

3214

MENTHA ARVENSIS OIL

E

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

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

3215

MENTHA HAPLOCALYX

A, E, H

3216

MENTHA PULEGIUM

A, H

D-Pulegone 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, the maximum recommended daily dose must be no more than 150 mg of Mentha pulegium oil or distillate.

When the medicine is for a use other than topical, the maximum recommended daily dose must be no more than 50 mg of Mentha pulegium oil or distillate.

3217

MENTHA SPICATA

A, E, H

3218

MENTHA X CARDIACA

A, E, H

3219

MENTHA X PIPERITA

A, E, H

3220

MENTHA X PIPERITA NOTHOSUBSP. CITRATA

A, H

3221

MENTHADIENYL ACETATE

E

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

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

3222

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%.

3223

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%.

3224

MENTHOL

A, E

When used as an active ingredient, permitted only in medicated space sprays and medicated lozenges.

3225

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%.

3226

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%.

3227

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%.

3228

MENTHOXYPROPANEDIOL

E

For oral use only.

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

3229

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%.

3230

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%.

3231

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 be no more than 5%.

When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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).

When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019:

- (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).

3232

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%.

3233

MENTHYL LACTATE

E

3234

MENYANTHES TRIFOLIATA

A, H

3235

MERCURIC CHLORIDE

H

Only for use as an active homoeopathic ingredient.

3236

MERCURY

H

Only for use as an active homoeopathic ingredient.

3237

MESPILUS GERMANICA

A, H

3238

METACRESOL

E

Only for use in topical medicines for dermal application.

3239

METHACRYLIC ACID COPOLYMER

E

Only for use in oral medicines.

3240

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%.

3241

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%.

3242

METHIONINE

A, E

3243

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%.

3244

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%.

3245

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%.

3246

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%.

3247

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%.

3248

METHYL ACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

3249

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%.

3250

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%.

3251

METHYL BENZOATE

E

Only for use in topical medicines for dermal application.

3252

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%.

3253

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%.

3254

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%.

3255

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%.

3256

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%.

3257

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%.

3258

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%.

3259

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%.

3260

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%.

3261

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%.

3262

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%.

3263

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%.

3264

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%.

3265

METHYL ETHER

E

Only for use in topical medicines for dermal application.

3266

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%.

3267

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%.

3268

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%.

3269

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.

3270

METHYL GLUCETH-20

E

Only for use in topical medicines for dermal application.

3271

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%.

3272

METHYL GLUCETH-20 SESQUIHYDRATE

E

Only for use in topical medicines for dermal application.

3273

METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

3274

METHYL GLUCOSE SESQUIOLEATE

E

Only for use in topical medicines for dermal application.

3275

METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

3276

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%.

3277

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%.

3278

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%.

3279

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%.

3280

METHYL HYDROGENATED ROSINATE

E

Only for use in topical medicines for dermal application.

3281

METHYL HYDROJASMONATE

E

Only for use in topical medicines for dermal application.

3282

METHYL HYDROXYBENZOATE

E

Medicines containing hydroxybenzoates require the following warning statement on the medicine label:

- (TOTBNZ) ‘Contains hydroxybenzoates’ (or words to this effect) if the medicine contains more than one hydroxybenzoate source OR ‘Contains [insert the approved name of hydroxybenzoate used]’ (or words to this effect) if product contains one hydroxybenzoate source.

3283

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%.

3284

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%.

3285

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%.

3286

METHYL ISOVALERATE

E

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

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

3287

METHYL JASMONATE

E

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

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

3288

METHYL LAURATE

E

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

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

3289

METHYL LINOLEATE

E

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

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

3290

METHYL LINOLENATE

E

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

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

3291

METHYL MAGNESIUM CHLORIDE

E

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

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

3292

METHYL METHACRYLATE

E

3293

METHYL METHACRYLATE CROSSPOLYMER

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 1%.

3294

METHYL METHOXY PYRAZINE

E

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

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

3295

METHYL MYRISTATE

E

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

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

3296

METHYL NAPHTHYL KETONE

E

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

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

3297

METHYL NONYL KETONE

E

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

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

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

3298

METHYL NONYLENATE

E

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

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

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

3299

METHYL OCTIN CARBONATE

E

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

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

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

3300

METHYL PALMITATE

E

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

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

3301

METHYL PHENYL CARBINOL

E

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

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

3302

METHYL PHENYL CARBINYL-ISO-BUTYRATE

E

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

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

3303

METHYL PHENYL GLYCIDATE

E

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

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

3304

METHYL PHENYLACETATE

E

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

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

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

3305

METHYL PHENYLCARBINYL ACETATE

E

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

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

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

3306

METHYL ROSINATE

E

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

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

3307

METHYL SALICYLATE

E

Not to be used orally, unless the concentration of methyl salicylate in the medicine is no more than 0.001%.

When the concentration of methyl salicylate in the medicine is more than 0.001%, 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.

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 but the delivery device must be 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.

3308

METHYL STEARATE

E

3309

METHYL THIOBUTYRATE

E

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

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

3310

METHYL TRIMETICONE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

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

3311

METHYL-3-METHYLTHIOPROPIONATE

E

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

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

3312

METHYL-BETA-METHYL THIOLPROPIONATE

E

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

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

3313

METHYL-PARA-TERT-BUTYL PHENYLACETATE

E

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

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

3314

METHYLBENZYL ACETATE

E

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

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

3315

METHYLCELLULOSE

A, E

3316

METHYLCHLOROISOTHIAZOLINONE

E

Only for use in topical medicines for dermal application that are rinsed off the skin.

The total concentration of methylchloroisothiazolinone and methylisothiazolinone in the medicine must be no more than 0.0015%.

3317

METHYLCYCLOHEXADIENE

E

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

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

3318

METHYLDIBROMO GLUTARONITRILE

E

Only for use in topical medicines for dermal application.

3319

METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 10%.

When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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).

When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019:

- (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).

3320

METHYLISOTHIAZOLINONE

E

Only for use in topical medicines for dermal application that are rinsed off the skin.