Schedule 1Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine

(section 4)

Part 2Table 1

Column 1

Column 2

Ingredient Name

Column 3

Purpose of the ingredient in the medicine

Column 4

Specific requirement(s) applying to the ingredient in Column 2

2800

KADSURA COCCINEA

A,H

 

2801

KAEMPFERIA GALANGA

A,H

 

2802

KALMIA LATIFOLIA

A,H

 

2803

KAOLIN

E

 

2804

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.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

2805

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.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.                                                             

2806

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%.

2807

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%. 

2808

KIDNEY BEAN

E

 

2809

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%.

2810

KIWI FRUIT

E

 

2811

KNAUTIA ARVENSIS

A,H

 

2812

KOREAN GINSENG ROOT DRY

A,H

 

2813

KOREAN GINSENG ROOT POWDER

A,H

 

2814

KRAMERIA IXIENA

A,H

 

2815

KRAMERIA LAPPACEA

A,H

 

2816

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'.

2817

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%.

2818

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%.

2819

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%.

2820

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%.

2821

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%.

2822

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%.

2823

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%.

2824

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%.

2825

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%.

2826

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%.

2827

LABDANUM OIL

A,E,H

 

2828

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%.

2829

LACTALBUMIN

E

 

2830

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.

2831

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'.

2832

LACTOBACILLUS ACIDOPHILUS

A

 

2833

LACTOBACILLUS AMYLOVORUS

A

 

2834

LACTOBACILLUS BREVIS

A

 

2835

LACTOBACILLUS CASEI

A

 

2836

LACTOBACILLUS CASEI SUBSP. BIOVAR CASEI

A

 

2837

LACTOBACILLUS CRISPATUS

A

 

2838

LACTOBACILLUS DELBRUECKII SSP BULGARICUS

A

 

2839

LACTOBACILLUS DELBRUECKII SSP LACTIS

A

 

2840

LACTOBACILLUS FERMENTUM

A

 

2841

LACTOBACILLUS GALLINARUM

A

 

2842

LACTOBACILLUS GASSERI

A

 

2843

LACTOBACILLUS HELVETICUS

A

 

2844

LACTOBACILLUS JOHNSONII

A

 

2845

LACTOBACILLUS KEFIRANOFACIENS

A

 

2846

LACTOBACILLUS KEFIRGRANUM

A

 

2847

LACTOBACILLUS KEFIRI

A

 

2848

LACTOBACILLUS PARACASEI

A

 

2849

LACTOBACILLUS PARACASEI SUBSP. PARACASEI

A

 

2850

LACTOBACILLUS PLANTARUM

A

 

2851

LACTOBACILLUS REUTERI

A

 

2852

LACTOBACILLUS RHAMNOSUS

A

 

2853

LACTOBACILLUS SALIVARIUS SSP SALICINIUS

A

 

2854

LACTOBACILLUS SALIVARIUS SSP SALIVARIUS

A

 

2855

LACTOBIONIC ACID

E

Only for use in topical medicines for dermal application.

2856

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%.

2857

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]’.

2858

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]’.

2859

LACTUCA SATIVA

A,H

 

2860

LACTUCA VIROSA

A,H

 

2861

LACTULOSE

E

 

2862

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.

2863

LAGENARIA VULGARIS

A,H

 

2864

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.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

2865

LAMINARIA DIGITATA

A,E,H

Iodine is a mandatory component of Laminaria digitata and must be declared in the application.

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.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

2866

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.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

2867

LAMIUM ALBUM

A,H

 

2868

LANETH-5

E

Only for use in topical medicines for dermal application.

2869

LANOLIN ALCOHOL

E

Only for use in topical medicines for dermal application.

2870

LANOLIN OIL

E

Only for use in topical medicines for dermal application.

2871

LANOLIN WAX

E

Only for use in topical medicines for dermal application.

2872

LANTANA CAMARA

A,H

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

2873

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%.

2874

LARIX DECIDUA

A,H

 

2875

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.

2876

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'.

2877

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.

2878

LAURAMINE OXIDE

E

 

2879

LAUREL LEAF OIL

A,H

 

2880

LAURETH-10

E

Only for use in topical medicines for dermal application.

2881

LAURETH-12

E

Only for use in topical medicines for dermal application.

2882

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.

2883

LAURETH-23

E

Only for use in topical medicines for dermal application.

2884

LAURETH-3

E

Only for use in topical medicines for dermal application.

2885

LAURETH-4

E

Only for use in topical medicines for dermal application.

2886

LAURETH-7

E

Only for use in topical medicines for dermal application.

2887

LAURETH-8

E

 

2888

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.

2889

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%.

2890

LAUROMACROGOL 400

E

Only for use in topical medicines for dermal application.

2891

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%.

2892

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'.

2893

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%.

2894

LAURYL BETAINE

E

Only for use in topical medicines for dermal application.

2895

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%.

2896

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.

2897

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%.

2898

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%.

2899

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%.

2900

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.

2901

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.

2902

LAURYL PYRROLIDONE

E

Only for use in topical medicines for dermal application.

2903

LAURYLDIMONIUM HYDROXYPROPYL HYDROLYSED COLLAGEN

E

Only for use in topical medicines for dermal application.

2904

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%.

2905

LAURYLMETICONE COPOLYOL

E

Only for use in topical medicines for dermal application.

2906

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%.

2907

LAVANDIN OIL ABRIAL

A,E,H

 

2908

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%.

2909

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.

2910

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.

2911

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%.

.

2912

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'.

2913

LAWSONIA INERMIS

A,H

 

2914

LEAD

H

Only for use as an active homoeopathic ingredient. 

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

2915

LEAD ACETATE

H

 Only for use as an active homoeopathic ingredient.

2916

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%.

2917

LECITHIN

A,E

 

2918

LEDEBOURIELLA SESELOIDES

A,H

 

2919

LEDUM GROENLANDICUM

A,H

 

2920

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.

2921

LEMNA MINOR

A,H

 

2922

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.

2923

LEMON BALM LEAF DRY

A,H

 

2924

LEMON BALM LEAF POWDER

A,E,H

 

2925

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.

2926

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.

2927

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.

2928

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%.

2929

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.

2930

LEMONGRASS OIL

A,E,H

 

2931

LENS CULINARIS

A,H

 

2932

LENTIL

E

 

2933

LENTINULA EDODES

A,E,H

 

2934

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%.

2935

LEONURUS CARDIACA

A,E,H

 

2936

LEONURUS SIBIRICUS

A,E,H

 

2937

LEPIDIUM APETALUM

A,H

 

2938

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).

2939

LEPTOSPERMUM PETERSONII

E

Only for use in topical medicines for dermal application.

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

2940

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’

2941

LESPEDEZA CAPITATA

A,H

 

2942

LETTUCE

E

 

2943

LEUCINE

A,E

 

2944

LEUZEA UNIFLORUM

A,H

 

2945

LEVISTICUM OFFICINALE

A,H

 

2946

LEVOCARNITINE

A

 

2947

LEVOCARNITINE FUMARATE

A

 

2948

LEVOCARNITINE HYDROCHLORIDE

A

 

2949

LEVOCARNITINE MAGNESIUM CITRATE

A

 

2950

LEVOCARNITINE TARTRATE

A

 

2951

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 statements 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)’; and

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet’.

2952

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 500mcg 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 mcg 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 statements 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)’; and

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet’.

2953

LEVOTHYROXINE SODIUM

H

Only for use as an active homoeopathic ingredient.

2954

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%.

2955

LIGHT KAOLIN

E

 

2956

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.

2957

LIGHT MAGNESIUM OXIDE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of light magnesium oxide.

The percentage of magnesium from light magnesium oxide should be calculated based on the molecular weight of light magnesium oxide.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

2958

LIGUSTICUM SINENSE

A,H

 

2959

LIGUSTICUM WALLICHII

A,E,H

 

2960

LIGUSTRUM LUCIDUM

A,H

 

2961

LILIUM BROWNII

A,H

 

2962

LILIUM CANDIDUM

A,E,H

 

2963

LILIUM LANCIFOLIUM

A,H

 

2964

LILIUM LONGIFLORUM

A,H

 

2965

LIME FRUIT

E

 

2966

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%.

2967

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.

2968

LIME OIL DISTILLED

A,E,H

 

2969

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%.

2970

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%.

2971

LIME TREE FLOWER DRY

A,H

 

2972

LIME TREE FLOWER POWDER

A,H

 

2973

LIME, ESSENCE

E

 

2974

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%.

2975

LIMONENE

E

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

2976

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%.

2977

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%.

2978

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%.

2979

LINALYL ACETATE

E

Only for use in topical medicines for dermal application.

2980

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%.

2981

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%.

2982

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%.

2983

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%.

2984

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%.

2985

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%.

2986

LINDERA STRYCHNIFOLIA

A,H

 

2987

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%.

2988

LINOLEIC ACID

E

 

2989

LINOLENIC ACID

E

 

2990

LINSEED DRY

A,E,H

 

2991

LINSEED OIL

A,E,H

 

2992

LINSEED POWDER

A,E,H

 

2993

LINUM USITATISSIMUM

A,E,H

 

2994

LIPASE

A

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

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

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

2995

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 100 mg 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).

2996

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.

2997

LIQUIDAMBAR FORMOSANA

A,H

 

2998

LIQUIDAMBAR ORIENTALIS

A,H

 

2999

LIQUIDAMBAR STYRACIFLUA

A,E,H

 

3000

LIQUIDAMBAR TAIWANIANA

A,H

 

3001

LIQUIDAMBER 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%.

3002

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%.

3003

LIQUORICE DRY

A,E,H

 

3004

LIQUORICE LIQUID EXTRACT

A,E,H

 

3005

LIQUORICE POWDER

A,E,H

 

3006

LITCHI CHINENSIS

A,H

 

3007

LITHIUM CARBONATE

H

 Only for use as an active homoeopathic ingredient. 

3008

LITHOSPERMUM OFFICINALE

A,H

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

3009

LITSEA CUBEBA

A,E,H

 

3010

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%.

3011

LOBARIA PULMONARIA

A,H

 

3012

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.

3013

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.

3014

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.

3015

LOLIUM PERENNE

A,H

 

3016

LOLIUM TEMULENTUM

A,H

 

3017

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%.

3018

LONICERA CAPRIFOLIUM

A,E,H

 

3019

LONICERA JAPONICA

A,E,H

 

3020

LONICERA PERICLYMENUM

A,H

 

3021

LOPHATHERUM GRACILE

A,H

 

3022

LOQUAT

E

 

3023

LORANTHUS PARASITICUS

A,H

 

3024

LOROPETALUM CHINENSIS

A,H

 

3025

LOTUS CORNICULATUS

A,H

 

3026

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%.

3027

LOVAGE OIL

A,E,H

 

3028

LOVAGE ROOT DRY

A,H

 

3029

LOVAGE ROOT POWDER

A,H

 

3030

LUDWIGIA PROSTRATA

A,H

 

3031

LUFFA CYLINDRICA

A,H

 

3032

LUFFA PURGANS

A,H

 

3033

LUTEIN

A,E,H

Permitted for use as a colour for oral and topical use.

3034

LYCHEE

E

 

3035

LYCIUM BARBARUM

A,H

 

3036

LYCIUM CHINENSE

A,E,H

 

3037

LYCOPENE

A,E

 

3038

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.

3039

LYCOPODIUM ANNOTINUM

A,H

 

3040

LYCOPODIUM CLAVATUM

A,H

 

3041

LYCOPODIUM COMPLANATUM

A,H

 

3042

LYCOPUS EUROPAEUS

A,H

 

3043

LYCOPUS LUCIDUS

A,H

 

3044

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%.

3045

LYGODIUM JAPONICUM

A,H

 

3046

LYSIMACHIA CHRISTINAE

A,H

 

3047

LYSIMACHIA VULGARIS

A,H

 

3048

LYSINE

A,E

 

3049

LYSINE HYDROCHLORIDE

A,E

 

3050

LYTHRUM HYSSOPIFOLIA

A,H

 

3051

LYTHRUM SALICARIA

A,H

 

3052

LYTHRUM VERTICILLATUM

A,H

 

3053

MACADAMIA INTEGRIFOLIA

A,E

 

3054

MACADAMIA NUT

E

 

3055

MACADAMIA NUT OIL

E

 

3056

MACADAMIA TERNIFOLIA

A,E,H

 

3057

MACE

E,H

Only for use as an active homoeopathic ingredient. 

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%.

3058

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.

3059

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.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3060

MACROGOL 1000

E

 

3061

MACROGOL 1450

E

Only for use in topical medicines for dermal application.

3062

MACROGOL 1500

E

 

3063

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%.

3064

MACROGOL 200

E

Only for use in topical medicines for dermal application.

3065

MACROGOL 20000

E

 

3066

MACROGOL 300

E

 

3067

MACROGOL 3000

E

 

3068

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.

3069

MACROGOL 40

E

Only for use in topical medicines for dermal application.

3070

MACROGOL 400

E

 

3071

MACROGOL 4000

E

 

3072

MACROGOL 45000

E

Only for use in topical medicines for dermal application.

3073

MACROGOL 600

E

 

3074

MACROGOL 6000

E

 

3075

MACROGOL 600000

E

 

3076

MACROGOL 800

E

 

3077

MACROGOL 8000

E

 

3078

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%.

3079

MACROGOL POLY(VINYL ALCOHOL) GRAFTED POLYMER

E

Only for use in oral medicines.

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

3080

MAGNESIUM AMINO ACID CHELATE

A,E,H

Only for use in oral medicines.

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

If used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of Magnesium amino acid chelate.

The quantity of magnesium in the medicine must be no more than 25%.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3081

MAGNESIUM ASCORBATE

A,E,H

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3082

MAGNESIUM ASCORBATE MONOHYDRATE

A,E,H

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3083

MAGNESIUM ASCORBYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

3084

MAGNESIUM ASPARTATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of magnesium aspartate tetrahydrate.

The percentage of Magnesium from magnesium aspartate tetrahydrate should be calculated based on the molecular weight of magnesium aspartate tetrahydrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.-

3085

MAGNESIUM ASPARTATE DIHYDRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of magnesium aspartate dihydrate. The percentage of magnesium from magnesium aspartate dihydrate should be calculated based on the molecular weight of magnesium aspartate dihydrate. The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3086

MAGNESIUM ASPARTATE TETRAHYDRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of magnesium aspartate tetrahydrate.

The percentage of Magnesium from magnesium aspartate tetrahydrate should be calculated based on the molecular weight of magnesium aspartate tetrahydrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3087

MAGNESIUM CARBONATE HYDRATE

A,E,H

If used as an active ingredient and the preparation is intended as a mineral supplementation, magnesium is a mandatory component of magnesium carbonate hydrate.

The amount of magnesium in the active ingredient should be calculated based on the molecular weight of magnesium carbonate hydrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3088

MAGNESIUM CHLORIDE 4.5-HYDRATE

A

If used as an active ingredient and the preparation is intended as a mineral supplementation, magnesium is a mandatory component of magnesium chloride 4.5-hydrate.

The percentage of magnesium from magnesium chloride 4.5-hydrate should be calculated based on the molecular weight of magnesium chloride 4.5-hydrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3089

MAGNESIUM CHLORIDE HEXAHYDRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of magnesium chloride hexahydrate.

The percentage of magnesium from magnesium chloride hexahydrate should be calculated based on the molecular weight of magnesium chloride hexahydrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3090

MAGNESIUM CITRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of magnesium citrate.

The percentage of magnesium from magnesium citrate should be calculated based on the molecular weight of magnesium citrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3091

MAGNESIUM CITRATE NONAHYDRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of magnesium citrate nonahydrate.

The percentage of magnesium from magnesium citrate nonahydrate should be calculated based on the molecular weight of magnesium citrate nonahydrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3092

MAGNESIUM CITRATE TETRADECAHYDRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of magnesium citrate tetradecahydrate.

The percentage of magnesium from magnesium citrate tetradecahydrate should be calculated based on the molecular weight of magnesium citrate tetradecahydrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3093

MAGNESIUM DIGLUTAMATE

A,E,H

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3094

MAGNESIUM GLUCONATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of magnesium gluconate.

The percentage of magnesium from magnesium gluconate should be calculated based on the molecular weight of magnesium gluconate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3095

MAGNESIUM GLYCEROPHOSPHATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of magnesium glycerophosphate.

The percentage of magnesium from magnesium glycerophosphate should be calculated based on the molecular weight of magnesium glycerophosphate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3096

MAGNESIUM GLYCINATE

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.

The percentage of Magnesium from Magnesium glycinate should be calculated based on the molecular weight of Magnesium glycinate

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3097

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 th eMagnesium glycinate dihydrate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations.

3098

MAGNESIUM HYDROGEN PHOSPHATE

H

 

3099

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.

3100

MAGNESIUM LYSINATE

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 lysinate.

The percentage of Magnesium from Magnesium lysinate should be calculated based on the molecular weight of Magnesium lysinate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3101

MAGNESIUM METHIONINATE

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 methioninate.

The percentage of magnesium from magnesium methioninate should be calculated based on the molecular weight of magnesium methioninate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3102

MAGNESIUM NITRATE

E

Only for use in topical medicines for dermal application.

3103

MAGNESIUM OROTATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of Magnesium orotate .

The percentage of magnesium from Magnesium orotate should be calculated based on the molecular weight of Magnesium orotate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3104

MAGNESIUM OROTATE DIHYDRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of magnesium orotate dihydrate.

The percentage of magnesium from magnesium orotate dihydrate should be calculated based on the molecular weight of magnesium orotate dihydrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3105

MAGNESIUM OXIDE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of Magnesium oxide.

The percentage of Magnesium from Magnesium oxide should be calculated based on the molecular weight of Magnesium oxide.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3106

MAGNESIUM PHOSPHATE PENTAHYDRATE

A,E,H

If used as an active ingredient and the preparation is intended as a mineral supplementation, magnesium is a mandatory component of magnesium phosphate pentahydrate.

The amount of magnesium in the active ingredient should be calculated based on the molecular weight of magnesium phosphate pentahydrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3107

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.

3108

MAGNESIUM PYRUVATE

A

Only for use in oral medicines.

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

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of magnesium pyruvate.

The percentage of magnesium from magnesium pyruvate should be calculated based on the molecular weight of pyruvate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3109

MAGNESIUM STEARATE

E

 

3110

MAGNESIUM SULFATE DIHYDRATE

A,E,H

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

When used as an active ingredient and the preparation is intended as a mineral supplementation, magnesium is a mandatory component of Magnesium sulfate dihydrate.

The percentage of Magnesium from Magnesium sulfate  dihydrate should be calculated based on the molecular weight of Magnesium sulfate dihydrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3111

MAGNESIUM SULFATE HEPTAHYDRATE

A,E,H

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

When used as an active ingredient and the preparation is intended as a mineral supplementation, magnesium is a mandatory component of magnesium sulfate heptahydrate.

The percentage of Magnesium from magnesium sulfate heptahydrate should be calculated based on the molecular weight of magnesium sulfate heptahydrate.

The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use.

3112

MAGNESIUM SULFATE MONOHYDRATE

A,E,H

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

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of Magnesium sulfate monohydrate.

The percentage of Magnesium from Magnesium sulfate monohydrate should be calculated based on the molecular weight of Magnesium sulfate monohydrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3113

MAGNESIUM SULFATE TRIHYDRATE

A,E,H

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

When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of Magnesium sulfate trihydrate.

The percentage of Magnesium from Magnesium sulfate trihydrate should be calculated based on the molecular weight of Magnesium sulfate trihydrate.

The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use.

3114

MAGNESIUM TRISILICATE

E

 

3115

MAGNOLIA GLAUCA

A,H

 

3116

MAGNOLIA LILIFLORA

A,H

 

3117

MAGNOLIA OBOVATA

A,H

 

3118

MAGNOLIA OFFICINALIS

A,E,H

 

3119

MAGNOLIA SALICIFOLIA

A,H

 

3120

MAIZE

E

 

3121

MAIZE BRAN

E

 

3122

MAIZE OIL

A,E,H

 

3123

MAIZE STARCH

A,E,H

 

3124

MALACHITE GREEN

E

Permitted for use as a colour for topical use.

3125

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.

3126

MALPIGHIA GLABRA

A,E,H

 

3127

MALT EXTRACT

E

 

3128

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]’.

3129

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).

3130

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).

3131

MALTOL

E

 

3132

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%.

3133

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).

3134

MALUS DOMESTICA

A,E,H

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

3135

MALUS PUMILA

A,E,H

 

3136

MALUS SYLVESTRIS

A,H

 

3137

MALVA MOSCHATA

A,H

 

3138

MALVA SYLVESTRIS

A,E,H

 

3139

MALVA VERTICILLATA

A,H

 

3140

MANDARIN

E

 

3141

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%.

3142

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.

3143

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%.

3144

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%.

3145

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%.

3146

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%.

3147

MANGANESE

H

Only for use as an active homoeopathic ingredient.

3148

MANGANESE (II) DIASPARTATE

A,H

Only for use in oral medicines.

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

Manganese is a mandatory component of Manganese (II) diaspartate.

The percentage of Manganese from Manganese (II) diaspartate should be calculated based on the molecular weight of Manganese (II) diaspartate.

The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use.

3149

MANGANESE (II) GLYCINATE

A,H

Only for use in oral medicines.

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

Manganese is a mandatory component of Manganese (II) glycinate.

The percentage of Manganese from Manganese (II) glycinate should be calculated based on the molecular weight of Manganese (II) glycinate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3150

MANGANESE ACETATE TETRAHYDRATE

H

Only for use as an active homoeopathic ingredient. 

3151

MANGANESE AMINO ACID CHELATE

A,E,H

Only for use in oral medicines.

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

If used as an active ingredient and the medicine is intended as a mineral supplementation, the equivalent quantity of Manganese.

The declared quantity of Manganese must be no more than 25% of the Manganese amino acid chelate in the formulation.

The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use.

3152

MANGANESE CHLORIDE TETRAHYDRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, manganese is a mandatory component of manganese chloride tetrahydrate.

The percentage of manganese from manganese chloride tetrahydrate should be calculated based on the molecular weight of manganese chloride tetrahydrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3153

MANGANESE DIASPARTATE

A,E,H

Only for use in oral medicines.

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

If used as an active ingredient and the medicine is intended as a mineral supplementation, the equivalent quantity of Manganese is required.

The declared quantity of Manganese must be no more than 25% of the manganese diaspartate in the formulation.

The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use.

3154

MANGANESE GLUCONATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, Manganese is a mandatory component of Manganese gluconate.

The percentage of Manganese from Manganese gluconate should be calculated based on the molecular weight of Manganese gluconate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3155

MANGANESE GLYCEROPHOSPHATE

A,E,H

When used as an active ingredient and the preparation is intended as a mineral supplementation, Manganese is a mandatory component of Manganese glycerophosphate.

The percentage of Manganese from Manganese glycerophosphate should be calculated based on the molecular weight of Manganese glycerophosphate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3156

MANGANESE OXIDE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, Manganese is a mandatory component of Manganese oxide.

The percentage of Manganese from Manganese oxide should be calculated based on the molecular weight of Manganese oxide.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3157

MANGANESE SULFATE MONOHYDRATE

A,E,H

If used as an active ingredient and the medicine is intended as a mineral supplementation, manganese is a mandatory component of Manganese sulfate monohydrate.

The percentage of manganese from Manganese sulfate monohydrate should be calculated based on the molecular weight of Manganese sulfate monohydrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3158

MANGANESE SULFATE TETRAHYDRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, manganese is a mandatory component of manganese sulfate tetrahydrate. The percentage of manganese from manganese sulfate tetrahydrate should be calculated based on the molecular weight of manganese sulfate tetrahydrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3159

MANGIFERA INDICA

A,E,H

 

3160

MANGO

E,H

 

3161

MANIHOT UTILISSIMA

A,H

 

3162

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).

3163

MARANTA ARUNDINACEA

A,H

 

3164

MARINE SPONGE

H

Only for use as an active homoeopathic ingredient.

3165

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).

3166

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).

3167

MARRUBIUM VULGARE

A,E,H

 

3168

MARSDENIA CUNDURANGO

A,H

 

3169

MARSHMALLOW ROOT DRY

A,H

 

3170

MARSHMALLOW ROOT POWDER

A,H

 

3171

MARTYNIA PARVIFLORA

A,H

 

3172

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%.

3173

MASTIC

A,H

 

3174

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%.

3175

MATRICARIA CHAMOMILLA

A,E,H

 

3176

MATRICARIA FLOWER DRY

A,E,H

 

3177

MATRICARIA RECUTITA

A,E,H

 

3178

MEADOWSWEET HERB DRY

A,H

 

3179

MEADOWSWEET HERB POWDER

A,H

 

3180

MECOBALAMIN (CO-METHYLCOBALAMIN)

A

Only for use in oral medicines.

3181

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.

3182

MEDIUM CHAIN TRIGLYCERIDES

E

 

3183

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.

3184

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.

3185

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.

3186

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.

3187

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.

3188

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.

3189

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.

3190

MELICOPE PTELEIFOLIA

A,H

 

3191

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%.

3192

MELISSA OFFICINALIS

A,E,H

 

3193

MELON

E

 

3194

MENADIONE SODIUM BISULFITE

E

 

3195

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.

3196

MENISPERMUM CANADENSE

A,H

 

3197

MENTHA AQUATICA

A,H

 

3198

MENTHA ARVENSIS

A,E,H

 

3199

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%.

3200

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%.

3201

MENTHA HAPLOCALYX

A,E,H

 

3202

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.

3203

MENTHA SPICATA

A,E,H

 

3204

MENTHA X CARDIACA

A,E,H

 

3205

MENTHA X PIPERITA

A,E,H

 

3206

MENTHA X PIPERITA NOTHOSUBSP. CITRATA

A,H

 

3207

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%.

3208

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%.

3209

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%.

3210

MENTHOL

A,E

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

3211

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%.

3212

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%.

3213

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%.

3214

MENTHOXYPROPANEDIOL

E

For oral use only.

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

3215

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%.

3216

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%.

3217

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%.

3218

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%.

3219

MENTHYL LACTATE

E

 

3220

MENYANTHES TRIFOLIATA

A,H

 

3221

MERCURIC CHLORIDE

H

Only for use as an active homoeopathic ingredient.

3222

MERCURY

H

Only for use as an active homoeopathic ingredient.

3223

MESPILUS GERMANICA

A,H

 

3224

METACRESOL

E

Only for use in topical medicines for dermal application.

3225

METHACRYLIC ACID COPOLYMER

E

Only for use in oral medicines.

3226

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%.

3227

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%.

3228

METHIONINE

A,E

 

3229

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%.

3230

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%.

3231

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%.

3232

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%.

3233

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%.

3234

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%.

3235

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%.

3236

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%.

3237

METHYL ACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

3238

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%.

3239

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%.

3240

METHYL BENZOATE

E

Only for use in topical medicines for dermal application.

3241

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%.

3242

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%.

3243

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%.

3244

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%.

3245

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%.

3246

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%.

3247

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%.

3248

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%.

3249

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%.

3250

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%.

3251

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%.

3252

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%.

3253

METHYL ETHER

E

Only for use in topical medicines for dermal application.

3254

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%.

3255

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%.

3256

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%.

3257

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.

3258

METHYL GLUCETH-20

E

Only for use in topical medicines for dermal application.

3259

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%.

3260

METHYL GLUCETH-20 SESQUIHYDRATE

E

Only for use in topical medicines for dermal application.

3261

METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

3262

METHYL GLUCOSE SESQUIOLEATE

E

Only for use in topical medicines for dermal application.

3263

METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

3264

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%.

3265

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%.

3266

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%.

3267

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%.

3268

METHYL HYDROGENATED ROSINATE

E

Only for use in topical medicines for dermal application.

3269

METHYL HYDROJASMONATE

E

Only for use in topical medicines for dermal application.

3270

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.

3271

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%.

3272

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%.

3273

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%.

3274

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%.

3275

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%.

3276

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%.

3277

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%.

3278

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%.

3279

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%.

3280

METHYL METHACRYLATE

E

 

3281

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%.

3282

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%.

3283

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%.

3284

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%.

3285

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%.

3286

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%.

3287

METHYL OCTIN CARBONATE

E

 

3288

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%.

3289

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%.

3290

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%.

3291

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%.

3292

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%.

3293

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%.

3294

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%.

3295

METHYL SALICYLATE

E

Only for use in topical medicines for dermal application.

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

For topical use, when the concentration in a liquid preparation is more than 5%, and the dosage form is other than spray, the medicine requires child resistant packaging.

For topical use, when the concentration 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 spay device is ergonomically difficult for young children to accomplish.

3296

METHYL STEARATE

E

 

3297

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%.

3298

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%.

3299

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%.

3300

METHYLCELLULOSE

A,E

 

3301

METHYLCHLOROISOTHIAZOLINONE

E

Only for use in topical medicines for dermal application.

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

3302

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%.

3303

METHYLDIBROMO GLUTARONITRILE

E

Only for use in topical medicines for dermal application.

3304

METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL

A

Only for use as an active ingredient in sunscreens.

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

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

3305

METHYLISOTHIAZOLINONE

E

Only for use in topical medicines for dermal application.

The concentration of  methylisothiazolinone in the medicine must be no more than 0.01%.

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

3306

METHYLMERCAPTAN

E

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

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

3307

METHYLPROPANEDIOL

E

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

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

3308

METHYLSILANOL/SILICATE CROSSPOLYMER

E

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

The concentration in the medicine must be no more than 0.1%.

3309

METHYLSTYRENE/VINYLTOLUENE COPOLYMER

E

Only for use in topical medicines for dermal application.

3310

MICA

E

Only for use when the route of administration is oral, dental or topical.

The concentration in oral medicines must be no more than 2.5%.

The concentration in dental toothpastes must be no more than 0.5%.

3311

MICROCALICIUM ARENARIUM

A,H

 

3312

MICROCOCCUS LUTEUS LYSATE

E

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

The concentration in the medicine must be no more than 0.005%.

3313

MICROCOS PANICULATA

A,H

 

3314

MICROCRYSTALLINE CELLULOSE

E

 

3315

MICROCRYSTALLINE WAX

E

Only for use as an excipient in medicines for topical, oral or oral application routes of administration.

When microcrystalline wax is used as an excipient ingredient, the route of administration 'oral' is only permitted when the dosage form is 'chewing gum'.

3316

MICROSPORUM GYPSEUM

A,H

 

3317

MILK FAT

E

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

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

3318

MILK THISTLE FRUIT DRY

A,H

 

3319

MILK THISTLE FRUIT POWDER

A,H

 

3320

MILLET

E

 

3321

MILLETTIA DIELSIANA

A,H

 

3322

MIMOSA ABSOLUTE

E

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

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

3323

MIMULUS GUTTATUS

A,H

 

3324

MINT OIL DEMENTHOLISED

A,E,H

 

3325

MINTLACTONE

E

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

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

3326

MITCHELLA REPENS

A,H

 

3327

MIXED (HIGH-ALPHA TYPE) TOCOPHEROLS CONCENTRATE

A,E

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

3328

MIXED (LOW-ALPHA TYPE) TOCOPHEROLS CONCENTRATE

A,E

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

3329

MIXED TERPENES

E

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

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

3330

MODIFIED FOOD STARCH

E

 

3331

MOLASSES

E

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

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

3332

MOLYBDENUM

H

Only for use as an active homoeopathic ingredient. 

When Molybdenum is sourced from Molybdenum trioxide then the maximum daily dose must be no more than 125 micrograms.

When Molybdenum is sourced from yeast - high molybdenum then the maximum recommended daily dose must be no more than 62.5 micrograms.

3333

MOLYBDENUM TRIOXIDE

A

Molybdenum is a mandatory component of Molybdenum trioxide.

The maximum daily dose of molybdenum from Molybdenum trioxide must be no more than 125 micrograms.

The percentage of molybdenum from molybdenum trioxide should be calculated based on the molecular weight of molybdenum trioxide.

3334

MOMORDICA BALSAMINA

A,H

 

3335

MOMORDICA CHARANTIA

A,H

 

3336

MOMORDICA COCHINCHINENSIS

A,H

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

3337

MONARDA DIDYMA

A,H

 

3338

MONO- AND DI- GLYCERIDES

E

 

3339

MONOBASIC AMMONIUM PHOSPHATE

E

Only for use in topical medicines for dermal application.

3340

MONOBASIC CALCIUM PHOSPHATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of monobasic calcium phosphate.

The percentage of calcium from monobasic calcium phosphate should be calculated based on the molecular weight of monobasic calcium phosphate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use.

3341

MONOBASIC DIHYDRATE SODIUM PHOSPHATE

E

When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5.

When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.

When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:

- (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).

3342

MONOBASIC POTASSIUM PHOSPHATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of monobasic potassium phosphate.

The percentage of potassium from monobasic potassium phosphate should be calculated based on the molecular weight of monobasic potassium phosphate.

When used in a solid medicine containing this ingredient, the pH of a 10 g/L aqueous solution must not be more than 11.5.

When used in a liquid or a semi-solid medicine containing this ingredient, the pH of the medicine must be no more than 11.5.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3343

MONOBASIC SODIUM PHOSPHATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, sodium is a mandatory component of monobasic sodium phosphate.

The percentage of sodium from monobasic sodium phosphate should be calculated based on the molecular weight of monobasic sodium phosphate.

When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5.

When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.

When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:

- (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

3344

MONOETHANOLAMINE

E

Only for use in topical medicines for dermal application.

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

3345

MONOPHOSPHOTHIAMINE

A

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

3346

MONOPHOSPHOTHIAMINE DIHYDRATE

A

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

3347

MONOPOTASSIUM GLUTAMATE

A,E

 

3348

MONOSODIUM DIHYDROGEN CITRATE

E

When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:

- (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’

3349

MONOSODIUM GLUTAMATE MONOHYDRATE

A,E

 

3350

MONSTERA DELICIOSA

A,H

 

3351

MONTAN WAX

E

 

3352

MORDANT RED 11

E

Permitted for use as a colour for topical use.

The concentration in the medicine must be no more than 0.05%.

3353

MORINDA CITRIFOLIA

A,H

Only for use when the plant part is fruit and the plant preparation is fruit juice or fruit powder.

Fruit powder must be produced by freeze drying the whole fruit (excluding the seeds).

3354

MORINDA OFFICINALIS

A,H

 

3355

MORINGA OLEIFERA

A,H

 

3356

MORUS ALBA

A,H

 

3357

MORUS BOMBYCIS

A,H

 

3358

MORUS NIGRA

A,E,H

 

3359

MOSKENE

E

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

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

3360

MOTHERWORT HERB DRY

A,H

 

3361

MOTHERWORT HERB POWDER

A,H

 

3362

MUCUNA PRURIENS

A,H

Levodopa (of Mucuna pruriens) is a mandatory component of Mucuna pruriens.

The concentration of Levodopa (of Mucuna pruriens) in the medicine must be no more than 1mg/kg or 1mg/L or 0.1%.

3363

MULBERRY

E

 

3364

MUNG BEAN

E

 

3365

MURRAYA KOENIGII

A,H

 

3366

MURRAYA PANICULATA

A,H

 

3367

MUSA X PARADISIACA

A,H

 

3368

MUSK KETONE

E

Only for use in topical medicines for dermal application.

3369

MUSK TIBETENE

E

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

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

3370

MUSK XYLOL

E

Only for use in topical medicines for dermal application.

3371

MUSKS

H

Only for use as an active homoeopathic ingredient. 

3372

MUSTARD

E

Allyl isothiocyanate is a mandatory component of Mustard.

The maximum daily dose must not provide more than 20 mg of allyl isothiocyanate.

3373

MUSTARD OIL

E

Allyl isothiocyanate is a mandatory component of Mustard oil.

The maximum daily dose must not provide more than 20 mg of allyl isothiocyanate.

3374

MUSTARD SEED OIL

E

Allyl isothiocyanate is a mandatory component of Mustard seed oil.

The maximum daily dose must not provide more than 20 mg of allyl isothiocyanate.

3375

MYOSOTIS ARVENSIS

A,H

 

3376

MYRCENE

E

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

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

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

3377

MYRCENYL ACETATE

E

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

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

3378

MYRICA CERIFERA

A,E,H

 

3379

MYRISTIC ACID

E

 

3380

MYRISTIC ALDEHYDE

E

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

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

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

3381

MYRISTICA FRAGRANS

A,E,H

Safrole is a mandatory component of Myristica fragrans.

When for internal use then the concentration of safrole in the medicine must be no more than 0.1%.

When for topical use then the concentration of safrole in the medicine must be no more than 1%.

When the plant preparation is oil or distillate and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and requires the following warning statement on the medicine label:

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

3382

MYRISTYL ALCOHOL

E

Only for use in topical medicines for dermal application.

3383

MYRISTYL LACTATE

E

Only for use in topical medicines for dermal application.

3384

MYRISTYL MYRISTATE

E

Only for use in topical medicines for dermal application.

3385

MYROXYLON BALSAMUM

A,E,H

 

3386

MYROXYLON BALSAMUM VAR. PEREIRAE

A,H

 

3387

MYRRH

A,H

 

3388

MYRRH OIL

A,E,H

 

3389

MYRRH RESIN

E

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

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

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

3390

MYRRHIS ODORATA

A,H

 

3391

MYRSINE AFRICANA

A,H

 

3392

MYRTENAL

E

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

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

3393

MYRTENYL ACETATE

E

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

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

3394

MYRTLE ESSENCE MAX

E

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

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

3395

MYRTLE OIL

E

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

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

3396

MYRTUS COMMUNIS

A,E,H

 

3397

N-BUTYL SULFIDE

E

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

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

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

3398

N-HEXYL 2-BUTENOATE

E

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

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

3399

N-NONYL ALCOHOL

E

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

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

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

3400

NAPHTHALENE

H

Only for use as an active homoeopathic ingredient. 

3401

NARDOSTACHYS CHINENSIS

A,H

 

3402

NARINGIN

E

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

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

3403

NASTURTIUM OFFICINALE

A,E,H

 

3404

NATURAL CHERRY FLAVOUR

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%.

3405

NATURAL FISH OIL

A,E

When therapeutic indications for this product are made against Vitamin A or colecalciferol (Vitamin D), they are mandatory components of fish oil - natural.

When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%.

When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents.

Divided preparations for internal use must contain more than 33 micrograms of Retinol Equivalents per dosage unit and no more than 3000 micrograms of Retinol Equivalents of Vitamin A in the maximum daily dose.

Undivided preparations for internal use must contain more than 33 micrograms Retinol Equivalents per gram of vitamin A and no more than 3000 micrograms of Retinol Equivalents of Vitamin A in the maximum daily dose.

When for use in adults the medicine requires the following warning statements on the medicine label:

- (VITA2) 'WARNING: If you are pregnant - or considering becoming pregnant - do not take vitamin A supplements without consulting your effect].' NOTE: Position this warning at the beginning of the directions for use.

- (VITA4) 'WARNING - When taken in excess of 3000 micrograms retinol equivalents - vitamin A can cause birth defects.' NOTE: Position this warning at the beginning of the directions for use.

- (VITA3) 'The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.'

When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of vitamin D.

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

The indication 'Vitamin D helps calcium absorption (or words of like intent)' and 'A diet deficient in calcium can lead to osteoporosis in later life' are permitted only for oral use.

3406

NAUCLEA OFFICINALIS

A,H

 

3407

NELUMBO NUCIFERA

A,H

 

3408

NELUMBO NUCIFERA FLOWER WAX

E

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

The concentration in the medicine must be no more than 0.1%.

3409

NEOHESPERIDIN-DIHYDROCHALCONE

E

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

The concentration in the medicine must be no more than 0.1%

3410

NEOMENTHOL

E

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

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

3411

NEOPENTYL GLYCOL DIHEPTANOATE

E

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

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

3412

NEOPENTYL GLYCOL DIISOSTEARATE

E

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

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

3413

NEOPENTYL GLYCOL DIOCTANOATE

E

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

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

3414

NEOPENTYL GLYCOL DIOCTANOATE/DIDECANOATE

E

Only for use in topical medicines for dermal application.

3415

NEOPICRORHIZA SCROPHULARIIFLORA

A,H

 

3416

NEPETA CATARIA

A,H

Pulegone is a mandatory component of Nepeta cataria and must be declared in the application.

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

3417

NERAL

E

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

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

3418

NERIUM OLEANDER

A,H

The concentration of equivalent dry Nerium oleander in the product must be no more than 1mg/Kg or 1mg/L or 0.0001%.

3419

NEROL

E

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

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

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

3420

NEROLIDOL

E

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

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

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

3421

NERYL-ISO-BUTYRATE

E

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

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

3422

NERYL ACETATE

E

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

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

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

3423

N-GLUCONYL ETHANOLAMINE

E

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

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

3424

NICKEL

H

Only for use as an active homoeopathic ingredient.

3425

NICOTIANA TABACUM

H

Only for use as an active homoeopathic ingredient.

3426

NICOTINAMIDE

A,E,H

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

3427

NICOTINAMIDE ASCORBATE

A,E

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

3428

NICOTINIC ACID

A,E

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

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

3429

NIGELLA DAMASCENA

A,H

 

3430

NIGELLA SATIVA

A,E,H

 

3431

NIGRITELLA ANGUSTIFOLIA

A,H

 

3432

NITRIC ACID

E,H

Only for use as an active homoeopathic ingredient. 

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

3433

NONADIENOL

E

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

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

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

3434

NONANAL

E

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

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

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

3435

NONANOIC ACID

E

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

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

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

3436

NONFAT DRY MILK

E,H

If the product is for oral ingestion and contains lactose, then the medicine requires the following warning statement on the medicine label:

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

3437

NONIVAMIDE

E

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

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

3438

NONOXINOL 10

E

Only for use in topical medicines for dermal application.

3439

NONOXINOL 12

E

For use in hand scrub formulations for healthcare professionals only.

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

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

3440

NONOXINOL 5

E

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

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

3441

NONOXINOL 9

E

Only for use in topical medicines for dermal application.

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

3442

NONYL ACETATE

E

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

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

3443

NOOTKATONE

E

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

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

3444

NOPYL ACETATE

E

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

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

3445

NORDIHYDROGUAIARETIC ACID

E

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

The concentration in the medicine must be no more than 0.3%.

3446

NOTOPTERYGIUM FORBESII

A,H

 

3447

NOTOPTERYGIUM INCISIUM

A,H

 

3448

NUPHAR JAPONICA

A,H

 

3449

NUPHAR LUTEA

A,H

 

3450

NUTMEG DRY

A,E,H

Safrole is a mandatory component of Nutmeg Dry.

When for internal use then the concentration of safrole from all ingredients in the medicine must be no more than 0.1%.

When for topical use then the concentration of safrole from all ingredients in the medicine must be no more than 1%.

3451

NUTMEG OIL

A,E,H

Safrole is a mandatory component of Nutmeg oil.

When for internal use then the concentration of safrole in the medicine must be no more than 0.1%.

When for topical use then the concentration of safrole in the medicine must be no more than 1%.

When the concentration of Nutmeg oil in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, the medicine must have a restricted flow insert fitted on the container and requires the following warning statement on the medicine label:

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

3452

NUTMEG POWDER

A,E,H

Safrole is a mandatory component of Nutmeg powder.

When for internal use then the concentration of safrole in the medicine must be no more than 0.1%.

When for topical use then the concentration of safrole in the medicine must be no more than 1%.

3453

NUX VOMICA DRY

A,H

Strychnine (of Strychnos spp.) is a mandatory component of Nux Vomica Dry.

The concentration of in the medicine must be no more than 1mg/Kg or 1mg/L or 0.0001%.

3454

NUX VOMICA POWDER

H

Only for use as an active homoeopathic ingredient.

Strychnine (of Strychnos spp.) is a mandatory component of Nux Vomica Powder.

The concentration in the medicine must be no more than 1mg/Kg or 1mg/L or 0.0001%.

3455

NYCTANTHES ARBOR-TRISTIS

A,H

 

3456

NYLON

E

Only for use in topical medicines for dermal application.

3457

NYLON-12

E

Only for use in topical medicines for dermal application.

3458

NYLON 6/12

E

Only for use in topical medicines for dermal application.

3459

NYMPHAEA ALBA

A,E,H

 

3460

NYMPHAEA CAERULEA

E

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

The concentration in the medicine to be no more than 0.3%. 

Only for use in liquid extracts where the plant part is the flower and the solvent in 100% water.

3461

NYMPHAEA ODORATA

A,H

 

3462

OAK CHIPS EXTRACT

E

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

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

3463

OAKMOSS

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%.

3464

OAKMOSS ABSOLUTE

E

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

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

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

3465

OAT

E,H

Only for use as a homoeopathic ingredient.

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

When the route of administration is other than topical or muscosal, the medicine requires the warning statement:

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

3466

OAT BRAN

E

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

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).

3467

OATMEAL COLLOIDAL

A,E

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

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).

3468

OCIMENE

E

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

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

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

3469

OCIMENYL ACETATE

E

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

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

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

3470

OCIMUM BASILICUM

A,E,H

When the plant preparation is oil or distillate, Methyl chavicol, eugenol, methyleugenol and cineole are mandatory components of Ocimum basilicum.

The concentration of methyleugenol in the medicine must not exceed 1%.

When the concentration of Methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25 millilitres.

When the concentration of Methyl chavicol in the medicine is more than 5% and the nominal capacity of the container is 25 millilitres or less, a restricted flow insert must be fitted on the container, and requires the following warning statement on the medicine label:

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

When the concentration of cineole OR eugenol in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres and the following warning statements must be included on the medicine label:

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

- (NTAKEN) 'Not to be taken'.

When the concentration of cineole OR eugenol in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container.

When the concentration of cineole OR eugenol in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container.

When the preparation is for topical use in the mouth, the preparation may not contain more than 5 millilitres of eugenol and the concentration of eugenol in the product must not be greater than 25%.

3471

OCIMUM KILIMANDSCHARICUM

A,H

Camphor is a mandatory component of Ocimum kilimandscharicum.

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

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

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

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

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

- (NTAKEN) 'Not to be taken'.

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

3472

OCIMUM MINIMUM

A,H

 

3473

OCIMUM TENUIFLORUM

A,H

When the plant part is oil or distillate, eugenol is a mandatory component of Ocimum tenuiflorum.

When the concentration of eugenol in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres and the following warning statements must be included on the medicine label:

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

- (NTAKEN) 'Not to be taken'.

When the concentration of eugenol in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container.

When the concentration of  eugenol in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container.

When the preparation is for topical use in the mouth, the preparation may not contain more than 5 mL of eugenol and the concentration of eugenol in the product must not be greater than 25%.

3474

OCOTEA ODORIFERA

A,H

Safrole is a mandatory component of Ocotea odorifera.

When for internal use then the concentration of safrole in the medicine must be no more than 0.1%.

When for topical use then the concentration of safrole in the medicine must be no more than 1%.

3475

OCTACOSANOL

E

 

3476

OCTADECANAL

E

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

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

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

3477

OCTADECENE/MA COPOLYMER

E

Only for use in topical medicines for dermal application.

3478

OCTAHYDRO-4,7-METHANO-3AH-INDENE-3A-CARBOXYLIC ACID, ETHYL ESTER

E

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

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

3479

OCTAHYDROCOUMARIN

E

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

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

3480

OCTAN-1-OL

E

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

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

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

3481

OCTANAL DIMETHYL ACETAL

E

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

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

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

3482

OCTANOHYDROXAMIC ACID

E

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

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

3483

OCTANOIC ACID

A

Only for use in oral and topical medicines.

When for topical use, the concentration in the medicine must be no more than 2% (w/w).

3484

OCTHILINONE

E

Only for use in topical medicines for dermal application.

3485

OCTOCRYLENE

A

Only for use as an active ingredient in sunscreens.

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

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

3486

OCTOXINOL 10

E

Only for use in topical medicines for dermal application.

3487

OCTYL ACETATE

E

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

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

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

3488

OCTYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

3489

OCTYL ISOBUTYRATE

E

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

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

3490

OCTYL ISONONANOATE

E

Only for use in topical medicines for dermal application.

3491

OCTYL METHOXYCINNAMATE

A

Only for use as an active ingredient in sunscreens.

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

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

3492

OCTYL PALMITATE

E

Only for use in topical medicines for dermal application.

3493

OCTYL SALICYLATE

A

Only for use as an active ingredient in sunscreens.

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%.

3494

OCTYL STEARATE

E

Only for use in topical medicines for dermal application.

3495

OCTYLBICYCLOHEPTENEDICARBOXIMIDE

E

Only for use in topical medicines for dermal application.

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

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

3496

OCTYLDODECANOL

E

Only for use in topical medicines for dermal application.

3497

OCTYLDODECETH-25

E

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

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

Residual levels of 1,4-dioxane and ethylene oxide (and related substances) are to be kept below the level of detection.

3498

OCTYLDODECYL CITRATE CROSSPOLYMER

E

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

The concentration in the medicine must be no more than 12%.

3499

OCTYLDODECYL NEOPENTANOATE

E

Only for use in topical medicines for dermal application.

3500

OCTYLDODECYL STEARATE

E

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

The concentration in the medicine must be no more than 2%.

3501

OENANTHATE

E

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

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

3502

OENANTHE AQUATICA

H

Only for use as an active homoeopathic ingredient. 

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

3503

OENANTHE CROCATA

A,H

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

3504

OENOTHERA BIENNIS

A,E,H

 

3505

OENOTHERA STRICTA

A,H

 

3506

OKOUBAKA AUBREVILLEI

A,H

 

3507

OLDENLANDIA DIFFUSA

A,E,H

 

3508

OLEA EUROPAEA

A,E,H

 

3509

OLEIC ACID

E

 

3510

OLETH-10

E

Only for use in topical medicines for dermal application.

3511

OLETH-2

E

Only for use in topical medicines for dermal application.

Dioxane and Ethylene oxide are mandatory components of Oleth-2.

The concentration of Dioxane in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%.

The concentration of Ethylene oxide in the medicine must be no more than 1 mg/kg or 1 mg/L or 0.0001%.

3512

OLETH-20

E

Only for use in topical medicines for dermal application.

3513

OLETH-3

E

Only for use in topical medicines for dermal application.

3514

OLETH-3 PHOSPHATE

E

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

The concentration in the medicine must be no more than 0.12%.

3515

OLETH-5

E

Only for use in topical medicines for dermal application.

3516

OLEYL ALCOHOL

E

Only for use in topical medicines for dermal application.

3517

OLIBANUM OIL

A,E,H

 

3518

OLIGOFRUCTOSE

A,E

 

3519

OLIVE

E

 

3520

OLIVE OIL

A,E,H

 

3521

OMEGA-3-ACID ETHYL ESTERS 90

A

Only for use in oral medicines.

The maximum recommended daily dose must not exceed 4000 mg of Omega-3-acid ethyl esters 90, AND must not provide more than 3750 mg EPA, DHA and DPA combined, when used alone or in combination with other sources of omega-3 fatty acids.

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

-‘Individuals taking anticoagulants should seek medical advice before taking this product’ (or words to that effect).

-‘To be taken with food’ (or words to that effect).

- 'Not recommended for used by pregnant and lactating women' (or words to that effect).

- 'Use in children under 12 years is not recommended' (or words to that effect).

3522

OMEGA-3 FISH OIL PHYTOSTEROL ESTERS

A

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

- (VOPE) 'There is no benefit from taking more than 3g/day of phytosterols from all sources'

- (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect).

3523

ONION

E

 

3524

ONION OIL

A,H

 

3525

ONONIS SPINOSA

A,E,H

 

3526

ONOPORDON ACANTHIUM

A,H

 

3527

ONOSMODIUM VIRGINIANUM

A,H

 

3528

OPHIOPOGON JAPONICUS

A,H

 

3529

OPOPANAX CHIRONIUM

A,H

 

3530

OPOPANAX OIL

E

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

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

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

3531

OPUNTIA FICUS-INDICA

A,H

 

3532

ORANGE

E

 

3533

ORANGE FLOWER ABSOLUTE

E

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

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

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

3534

ORANGE FLOWER OIL

A,E,H

When used internally, oxedrine is a mandatory component of orange flower oil.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.

3535

ORANGE JUICE

E

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

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

3536

ORANGE JUICE OIL

E

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

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

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

3537

ORANGE OIL

A,E,H

When used internally, oxedrine is a mandatory component of orange oil.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.

3538

ORANGE OIL BITTER

E

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

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

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

3539

ORANGE OIL BITTER COLDPRESSED

A,E,H

When used internally, oxedrine is a mandatory component of orange oil bitter coldpressed.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.

The warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is:

a) for internal use; or

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

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

3540

ORANGE OIL COLD PRESSED

E

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

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

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

3541

ORANGE OIL DISTILLED

A,E,H

When used internally, oxedrine is a mandatory component of orange oil distilled.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.

3542

ORANGE OIL SWEET

E

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

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

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

3543

ORANGE OIL TERPENELESS

A,E,H

When used internally, oxedrine is a mandatory component of orange oil terpeneless.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.

3544

ORANGE PEEL

E

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

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

3545

ORANGE PEEL DRIED BITTER

A,E,H

When used internally, oxedrine is a mandatory component of orange peel dried bitter.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.

3546

ORANGE PEEL OIL SWEET TERPENELESS

E

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

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

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

3547

ORANGE ROUGHY OIL

E

Only for use in topical medicines for dermal application.

3548

OREODAPHNE CALIFORNICA

A,H

 

3549

ORIGANUM MAJORANA

A,H

When the plant preparation is oil or distillate, the nominal capacity of the container must be no more than 50 millilitres.

When the concentration of Origanum majorana oil or distillate in the preparation is greater than 50%, a restricted flow insert must be fitted on the container and the medicine must include the following warning statement on the medicine label:

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

3550

ORIGANUM OIL

E

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

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

3551

ORIGANUM OIL SPANISH

A,E,H

 

3552

ORIGANUM VULGARE

A,E,H

 

3553

ORNITHINE

A,E

 

3554

ORNITHINE ASPARTATE

A,E

 

3555

ORNITHINE MONOHYDROCHLORIDE

A,E

 

3556

ORNITHOGALUM UMBELLATUM

A,H

 

3557

OROSTACHYS FIMBRIATA

A,H

 

3558

OROXYLUM INDICUM

A,H

 

3559

ORRIS

E

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

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

3560

ORRIS CONCRETE

E

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

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

3561

ORRIS ROOT EXTRACT

E

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

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

3562

ORRIS ROOT OIL

A,E,H

 

3563

ORRIS ROOT RESIN

E

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

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

3564

ORTHO-CYMEN-5-OL

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 0.1%.

3565

ORTHO-TERT-BUTYLCYCLOHEXYL ACETATE

E

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

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

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

3566

ORTHOSIPHON ARISTATUS

A,H

 

3567

ORYZA SATIVA

A,E,H

 

3568

ORYZANOL

E

 

3569

OSBECKIA CHINENSIS

A,H

 

3570

OSMANTHUS ABSOLUTE

E

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

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

3571

OSMANTHUS FRAGRANS

E

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

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

3572

OTTELIA ALISMOIDES

A,H

 

3573

OXACYCLOHEPTADEC-11-EN-2-ONE

E

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

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

3574

OXACYCLOHEXADECAN-2-ONE

E

Only for use in topical medicines for dermal application.

3575

OXACYCLOHEXADECEN-2-ONE

E

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

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

3576

OXALIC ACID

H

Only for use as an active homoeopathic ingredient. 

3577

OXALIS ACETOSELLA

A,H

 

3578

OXIDISED MAIZE STARCH

E

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

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

3579

OXIDISED TAPIOCA STARCH

E

 

3580

OXYBENZONE

A

Only for use as an active ingredient in sunscreens. 

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

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

3581

OYSTER

E

 

3582

OYSTER SHELL

A,E,H