2856

KADSURA COCCINEA

A, H

2857

KAEMPFERIA GALANGA

A, H

2858

KALMIA LATIFOLIA

A, H

Beta-arbutin is a mandatory component of Kalmia latifolia.

When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.

When for dermal application exclusively to the face:

a) the concentration of beta-arbutin in the medicine must not be more than 7%;

b) hydroquinone is a mandatory component; and

c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.

When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

2859

KAOLIN

E

2860

KELP DRY

A, H

Iodine is a mandatory component of Kelp dry.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

2861

KELP POWDER

A, E, H

Iodine is a mandatory component of Kelp powder.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

2862

KERATIN

E

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

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

2863

KEROSENE

E, H

Only for use as a homoeopathic ingredient. 

When used in liquid preparations, the concentration in the medicine must be no more than 25%. 

2864

KHAYA SENEGALENSIS

A, E

The maximum daily dose of the medicine must not contain more than the equivalent of 1 g dry bark of Khaya senegalensis.

The following warning statements are required on the medicine label:

- (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect);

- (LONGUSE) ‘Not for prolonged use. May harm liver';

- (GEN2) ‘If symptoms persist, seek the advice of a healthcare professional’;

- (CHILD3) ‘Use in children under 12 years is not recommended’; and

- (7DAYS) 'Do not use for more than 7 days'.

2865

KIDNEY BEAN

E

2866

KIRSCH

E

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

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

2867

KIWI FRUIT

E

2868

KNAUTIA ARVENSIS

A, H

2869

KOREAN GINSENG ROOT DRY

A, H

2870

KOREAN GINSENG ROOT POWDER

A, H

2871

KRAMERIA IXIENA

A, H

2872

KRAMERIA LAPPACEA

A, H

2873

KUNZEA AMBIGUA

A

Only for use when the plant preparation is essential oil.

Only for use when the route of administration is topical or inhalation.

When the dosage form is essential oil, a restricted flow insert must be fitted on the container and the medicine requires the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children'

- (EXTERN) 'For external use only'

- (UNDILU) 'Not to be applied undiluted to the skin except on the advice of a health care practitioner'.

When the dosage form is other than essential oil, the maximum concentration in topical medicines must be no more than 25% w/w and the medicine requires the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children'

- (EXTERN) 'For external use only'.

2874

L-BORNEOL

E

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

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

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

2875

L-BORNYL ACETATE

E

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

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

2876

L-CARVONE

E

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

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

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

2877

L-LIMONENE

E

Permitted for use only in combination with 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%.

2878

L-LINALOOL

E

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

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

2879

L-MENTHONE

E

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

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

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

2880

L-MENTHYL ACETATE

E

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

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

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

2881

L-ROSE OXIDE

E

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

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

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

2882

LABDANUM ABSOLUTE

E

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

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

2883

LABDANUM GUM EXTRACT ETHYL ESTER

E

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

If used in a fragrance and the total fragrance concentration in a medicine is no more than 1%.

2884

LABDANUM OIL

A, E, H

2885

LABURNUM ANAGYROIDES

A, H

Sparteine is a mandatory component of Laburnum anagyroides.

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

2886

LACTALBUMIN

E

2887

LACTIC ACID

A, E, H

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

Sponsors should consider the impact of excipients containing alpha hydroxy acids on the sensitivity of the skin to sunlight and should ensure the finished medicine is safe for its intended purpose.

2888

LACTITOL

E

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'.

2889

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'.

2890

LACTOBACILLUS ACIDOPHILUS

A

2891

LACTOBACILLUS AMYLOVORUS

A

2892

LACTOBACILLUS BREVIS

A

2893

LACTOBACILLUS CASEI

A

2894

LACTOBACILLUS CASEI SUBSP. BIOVAR CASEI

A

2895

LACTOBACILLUS CRISPATUS

A

2896

LACTOBACILLUS DELBRUECKII SSP BULGARICUS

A

2897

LACTOBACILLUS DELBRUECKII SSP LACTIS

A

2898

LACTOBACILLUS FERMENTUM

A

2899

LACTOBACILLUS GALLINARUM

A

2900

LACTOBACILLUS GASSERI

A

2901

LACTOBACILLUS HELVETICUS

A

2902

LACTOBACILLUS JOHNSONII

A

2903

LACTOBACILLUS KEFIRANOFACIENS

A

2904

LACTOBACILLUS KEFIRGRANUM

A

2905

LACTOBACILLUS KEFIRI

A

2906

LACTOBACILLUS PARACASEI

A

2907

LACTOBACILLUS PARACASEI SUBSP. PARACASEI

A

2908

LACTOBACILLUS PLANTARUM

A

2909

LACTOBACILLUS REUTERI

A

2910

LACTOBACILLUS RHAMNOSUS

A

2911

LACTOBACILLUS SALIVARIUS SSP SALICINIUS

A

2912

LACTOBACILLUS SALIVARIUS SSP SALIVARIUS

A

2913

LACTOBIONIC ACID

E

Only for use in topical medicines for dermal application.

2914

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%.

2915

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]’.

2916

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]’.

2917

LACTUCA SATIVA

A, H

2918

LACTUCA VIROSA

A, H

2919

LACTULOSE

E

2920

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.

2921

LAGENARIA VULGARIS

A, H

2922

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.

2923

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.

2924

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.

2925

LAMIUM ALBUM

A, H

2926

LANETH-5

E

Only for use in topical medicines for dermal application.

2927

LANOLIN ALCOHOL

E

Only for use in topical medicines for dermal application.

2928

LANOLIN OIL

E

Only for use in topical medicines for dermal application.

2929

LANOLIN WAX

E

Only for use in topical medicines for dermal application.

2930

LANTANA CAMARA

A, H

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

2931

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%.

2932

LARIX DECIDUA

A, H

2933

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.

2934

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'.

2935

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.

2936

LAURAMINE OXIDE

E

2937

LAUREL LEAF OIL

A, H

2938

LAURETH-10

E

Only for use in topical medicines for dermal application.

2939

LAURETH-12

E

Only for use in topical medicines for dermal application.

2940

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.

2941

LAURETH-23

E

Only for use in topical medicines for dermal application.

2942

LAURETH-3

E

Only for use in topical medicines for dermal application.

2943

LAURETH-4

E

Only for use in topical medicines for dermal application.

2944

LAURETH-7

E

Only for use in topical medicines for dermal application.

2945

LAURETH-8

E

2946

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.

2947

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%.

2948

LAUROMACROGOL 400

E

Only for use in topical medicines for dermal application.

2949

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%.

2950

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'.

2951

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%.

2952

LAURYL BETAINE

E

Only for use in topical medicines for dermal application.

2953

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%.

2954

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.

2955

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%.

2956

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%.

2957

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%.

2958

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.

2959

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.

2960

LAURYL PYRROLIDONE

E

Only for use in topical medicines for dermal application.

2961

LAURYLDIMONIUM HYDROXYPROPYL HYDROLYSED COLLAGEN

E

Only for use in topical medicines for dermal application.

2962

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%.

2963

LAURYLMETICONE COPOLYOL

E

Only for use in topical medicines for dermal application.

2964

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%.

2965

LAVANDIN OIL ABRIAL

A, E, H

2966

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%.

2967

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%.

2968

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%.

2969

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%.

2970

LAVENDER OIL

A, E, H

2971

LAWSONIA INERMIS

A, H

2972

LEAD

H

Only for use as an active homoeopathic ingredient.

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

2973

LEAD ACETATE

H

Only for use as an active homoeopathic ingredient.

2974

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%.

2975

LECITHIN

A, E

2976

LEDEBOURIELLA SESELOIDES

A, H

2977

LEDUM GROENLANDICUM

A, H

2978

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.

2979

LEMNA MINOR

A, H

2980

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.

2981

LEMON BALM LEAF DRY

A, H

2982

LEMON BALM LEAF POWDER

A, E, H

2983

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.

2984

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.

2985

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.

2986

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%.

2987

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.

2988

LEMONGRASS OIL

A, E, H

2989

LENS CULINARIS

A, H

2990

LENTIL

E

2991

LENTINULA EDODES

A, E, H

2992

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%.

2993

LEONURUS CARDIACA

A, E, H

2994

LEONURUS SIBIRICUS

A, E, H

2995

LEPIDIUM APETALUM

A, H

2996

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).

2997

LEPTOSPERMUM PETERSONII

E

Only for use in topical medicines for dermal application.

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

2998

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’

2999

LESPEDEZA CAPITATA

A, H

3000

LETTUCE

E

3001

LEUCINE

A, E

3002

LEUZEA UNIFLORUM

A, H

3003

LEVISTICUM OFFICINALE

A, H

3004

LEVOCARNITINE

A

3005

LEVOCARNITINE FUMARATE

A

3006

LEVOCARNITINE HYDROCHLORIDE

A

3007

LEVOCARNITINE MAGNESIUM CITRATE

A

3008

LEVOCARNITINE TARTRATE

A

3009

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.

When used in preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects the following warning statement is required on the medicine 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)’.

3010

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.

When used in preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects the following warning statement is required on the medicine 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).'

3011

LEVOTHYROXINE SODIUM

H

Only for use as an active homoeopathic ingredient.

3012

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%.

3013

LIGHT KAOLIN

E

3014

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.

3015

LIGHT MAGNESIUM OXIDE

A, E, H

3016

LIGUSTICUM SINENSE

A, H

3017

LIGUSTICUM STRIATUM

A, E, H

3018

LIGUSTRUM LUCIDUM

A, H

3019

LILIUM BROWNII

A, H

3020

LILIUM CANDIDUM

A, E, H

3021

LILIUM LANCIFOLIUM

A, H

3022

LILIUM LONGIFLORUM

A, H

3023

LIME FRUIT

E

3024

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%.

3025

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.

3026

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.

3027

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%.

3028

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%.

3029

LIME TREE FLOWER DRY

A, H

3030

LIME TREE FLOWER POWDER

A, H

3031

LIME, ESSENCE

E

3032

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%.

3033

LIMONENE

E

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

3034

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%.

3035

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%.

3036

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%.

3037

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%.

3038

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%.

3039

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%.

3040

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%.

3041

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%.

3042

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%.

3043

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%.

3044

LINDERA STRYCHNIFOLIA

A, H

3045

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%.

3046

LINOLEIC ACID

E

3047

LINOLENIC ACID

E

3048

LINSEED DRY

A, E, H

3049

LINSEED OIL

A, E, H

3050

LINSEED POWDER

A, E, H

3051

LINUM USITATISSIMUM

A, E, H

3052

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.

3053

LIPPIA DULCIS

A, H

3054

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).

3055

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.

3056

LIQUIDAMBAR FORMOSANA

A, H

3057

LIQUIDAMBAR ORIENTALIS

A, H

3058

LIQUIDAMBAR STYRACIFLUA

A, E, H

3059

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%.

3060

LIQUIDAMBAR TAIWANIANA

A, H

3061

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%.

3062

LIQUORICE DRY

A, E, H

3063

LIQUORICE LIQUID EXTRACT

A, E, H

3064

LIQUORICE POWDER

A, E, H

3065

LITCHI CHINENSIS

A, H

3066

LITHIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

3067

LITHOSPERMUM OFFICINALE

A, H

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

3068

LITSEA CUBEBA

A, E, H

3069

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%.

3070

LOBARIA PULMONARIA

A, H

3071

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.

3072

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.

3073

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.

3074

LOLIUM PERENNE

A, H

3075

LOLIUM TEMULENTUM

A, H

3076

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%.

3077

LONICERA CAPRIFOLIUM

A, E, H

3078

LONICERA JAPONICA

A, E, H

3079

LONICERA PERICLYMENUM

A, H

3080

LOPHATHERUM GRACILE

A, H

3081

LOQUAT

E

3082

LORANTHUS PARASITICUS

A, H

3083

LOROPETALUM CHINENSIS

A, H

3084

LOTUS CORNICULATUS

A, H

3085

LOVAGE OIL

A, E, H

3086

LOVAGE ROOT DRY

A, H

3087

LOVAGE ROOT POWDER

A, H

3088

LUDWIGIA PROSTRATA

A, H

3089

LUFFA CYLINDRICA

A, H

3090

LUFFA PURGANS

A, H

3091

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.

3092

LYCHEE

E

3093

LYCIUM BARBARUM

A, H

3094

LYCIUM CHINENSE

A, E, H

3095

LYCOPENE

A, E

3096

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.

3097

LYCOPODIUM ANNOTINUM

A, H

3098

LYCOPODIUM CLAVATUM

A, H

3099

LYCOPODIUM COMPLANATUM

A, H

3100

LYCOPUS EUROPAEUS

A, H

3101

LYCOPUS LUCIDUS

A, H

3102

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%.

3103

LYGODIUM JAPONICUM

A, H

3104

LYSIMACHIA CHRISTINAE

A, H

3105

LYSIMACHIA VULGARIS

A, H

3106

LYSINE

A, E

3107

LYSINE HYDROCHLORIDE

A, E

3108

LYTHRUM HYSSOPIFOLIA

A, H

3109

LYTHRUM SALICARIA

A, H

3110

LYTHRUM VERTICILLATUM

A, H

3111

MACADAMIA INTEGRIFOLIA

A, E

3112

MACADAMIA NUT

E

3113

MACADAMIA NUT OIL

E

3114

MACADAMIA TERNIFOLIA

A, E, H

3115

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%.

3116

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.

3117

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.

3118

MACROGOL 1000

E

3119

MACROGOL 1450

E

Only for use in topical medicines for dermal application.

3120

MACROGOL 1500

E

3121

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%.

3122

MACROGOL 200

E

Only for use in topical medicines for dermal application.

3123

MACROGOL 20000

E

3124

MACROGOL 300

E

3125

MACROGOL 3000

E

3126

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.

3127

MACROGOL 40

E

Only for use in topical medicines for dermal application.

3128

MACROGOL 400

E

3129

MACROGOL 4000

E

3130

MACROGOL 45000

E

Only for use in topical medicines for dermal application.

3131

MACROGOL 600

E

3132

MACROGOL 6000

E

3133

MACROGOL 600000

E

3134

MACROGOL 800

E

3135

MACROGOL 8000

E

3136

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%.

3137

MACROGOL POLY(VINYL ALCOHOL) GRAFTED POLYMER

E

Only for use in oral medicines.

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

3138

MACROPIPER EXCELSUM VAR EXCELSUM

A, H

3139

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.

3140

MAGNESIUM ASCORBATE

A, E, H

3141

MAGNESIUM ASCORBATE MONOHYDRATE

A, E, H

3142

MAGNESIUM ASCORBYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

3143

MAGNESIUM ASPARTATE

A, E, H

3144

MAGNESIUM ASPARTATE DIHYDRATE

A, E, H

3145

MAGNESIUM ASPARTATE TETRAHYDRATE

A, E, H

3146

MAGNESIUM CARBONATE HYDRATE

A, E, H

3147

MAGNESIUM CHLORIDE 4.5-HYDRATE

A

3148

MAGNESIUM CHLORIDE HEXAHYDRATE

A, E, H

3149

MAGNESIUM CITRATE

A, E, H

3150

MAGNESIUM CITRATE NONAHYDRATE

A, E, H

3151

MAGNESIUM CITRATE TETRADECAHYDRATE

A, E, H

3152

MAGNESIUM DIGLUTAMATE

A, E, H

3153

MAGNESIUM GLUCONATE

A, E, H

3154

MAGNESIUM GLYCEROPHOSPHATE

A, E, H

3155

MAGNESIUM GLYCINATE

A

Only for use in oral medicines.

3156

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.

3157

MAGNESIUM HYDROGEN PHOSPHATE

H

3158

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, the following warning statements are required on the label:

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

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

3159

MAGNESIUM LYSINATE

A

Only for use in oral medicines.

3160

MAGNESIUM METHIONINATE

A

Only for use in oral medicines.

3161

MAGNESIUM NITRATE

E

Only for use in topical medicines for dermal application.

3162

MAGNESIUM OROTATE

A, E, H

3163

MAGNESIUM OROTATE DIHYDRATE

A, E, H

3164

MAGNESIUM OXIDE

A, E, H

3165

MAGNESIUM PHOSPHATE PENTAHYDRATE

A, E, H

3166

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.

3167

MAGNESIUM PYRUVATE

A

Only for use in oral medicines.

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

3168

MAGNESIUM STEARATE

E

3169

MAGNESIUM SULFATE DIHYDRATE

A, E, H

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

3170

MAGNESIUM SULFATE HEPTAHYDRATE

A, E, H

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

3171

MAGNESIUM SULFATE MONOHYDRATE

A, E, H

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

3172

MAGNESIUM SULFATE TRIHYDRATE

A, E, H

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

3173

MAGNESIUM TRISILICATE

E

3174

MAGNOLIA GLAUCA

A, H

3175

MAGNOLIA LILIFLORA

A, H

3176

MAGNOLIA OBOVATA

A, H

3177

MAGNOLIA OFFICINALIS

A, E, H

3178

MAGNOLIA SALICIFOLIA

A, H

3179

MAIZE

E

3180

MAIZE BRAN

E

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

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]’.

3188

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).

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

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).

3193

MALUS DOMESTICA

A, E, H

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

3194

MALUS PUMILA

A, E, H

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

3195

MALUS SYLVESTRIS

A, H

3196

MALVA MOSCHATA

A, H

3197

MALVA SYLVESTRIS

A, E, H

3198

MALVA VERTICILLATA

A, H

3199

MANDARIN

E

3200

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%.

3201

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.

3202

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%.

3203

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%.

3204

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%.

3205

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%.

3206

MANGANESE

H

Only for use as an active homoeopathic ingredient.

3207

MANGANESE (II) DIASPARTATE

A, H

Only for use in oral medicines.

3208

MANGANESE (II) GLYCINATE

A, H

Only for use in oral medicines.

3209

MANGANESE ACETATE TETRAHYDRATE

H

Only for use as an active homoeopathic ingredient. 

3210

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.

3211

MANGANESE CHLORIDE TETRAHYDRATE

A, E, H

3212

MANGANESE DIASPARTATE

A, E, H

Only for use in oral medicines.

3213

MANGANESE GLUCONATE

A, E, H

3214

MANGANESE GLYCEROPHOSPHATE

A, E, H

3215

MANGANESE OXIDE

A, E, H

3216

MANGANESE SULFATE MONOHYDRATE

A, E, H

3217

MANGANESE SULFATE TETRAHYDRATE

A, E, H

3218

MANGIFERA INDICA

A, E, H

3219

MANGO

E, H

3220

MANIHOT ESCULENTA

A, H

3221

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).

3222

MARANTA ARUNDINACEA

A, H

3223

MARINE SPONGE

H

Only for use as an active homoeopathic ingredient.

3224

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).

3225

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).

3226

MARRUBIUM VULGARE

A, E, H

3227

MARSDENIA CUNDURANGO

A, H

3228

MARSHMALLOW ROOT DRY

A, H

3229

MARSHMALLOW ROOT POWDER

A, H

3230

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%.

3231

MASTIC

A, H

3232

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%.

3233

MATRICARIA CHAMOMILLA

A, E, H

3234

MATRICARIA FLOWER DRY

A, E, H

3235

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'.

3236

MECOBALAMIN (CO-METHYLCOBALAMIN)

A

Only for use in oral medicines.

3237

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.

3238

MEDIUM CHAIN TRIGLYCERIDES

E

3239

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.

3240

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.

3241

MELALEUCA CITRINA

A, H

3242

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.

3243

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.

3244

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.

3245

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.

3246

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.

3247

MELICOPE PTELEIFOLIA

A, H

3248

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%.

3249

MELISSA OFFICINALIS

A, E, H

3250

MELON

E

3251

MENADIONE SODIUM BISULFITE

E

3252

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.

3253

MENISPERMUM CANADENSE

A, H

3254

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.

3255

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.

3256

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.

3257

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.

3258

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.

3259

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.

3260

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.

3261

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.

3262

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.

3263

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.

3264

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%.

3265

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%.

3266

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.

3267

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%.

3268

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%.

3269

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%.

3270

MENTHOXYPROPANEDIOL

E

For oral use only.

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

3271

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%.

3272

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%.

3273

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).

3274

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%.

3275

MENTHYL LACTATE

E

3276

MENYANTHES TRIFOLIATA

A, H

3277

MERCURIC CHLORIDE

H

Only for use as an active homoeopathic ingredient.

3278

MERCURY

H

Only for use as an active homoeopathic ingredient.

3279

METACRESOL

E

Only for use in topical medicines for dermal application.

3280

METHACRYLIC ACID COPOLYMER

E

Only for use in oral medicines.

3281

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%.

3282

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%.

3283

METHIONINE

A, E

3284

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%.

3285

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%.

3286

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%.

3287

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%.

3288

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%.

3289

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%.

3290

METHYL ACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

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

Only for use in topical medicines for dermal application.

3325

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.

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

E

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

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

3330

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%.

3331

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%.

3332

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%.

3333

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%.

3334

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%.

3335

METHYL METHACRYLATE

E

3336

METHYL METHACRYLATE CROSSPOLYMER

E

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

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

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

3337

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%.

3338

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%.

3339

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%.

3340

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%.

3341

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%.

3342

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%.

3343

METHYL PALMITATE

E

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