2123

FABIANA IMBRICATA

A, H

2124

FAGOPYRUM ESCULENTUM

A, H

2125

FAGUS GRANDIFOLIA

A, H

2126

FAGUS SYLVATICA

A, H

2127

FALLOPIA JAPONICA

A, E, H

2128

FALLOPIA MULTIFLORA

A, H

When for oral use, the medicine requires the following warning statement on the medicine label:

- (FALLMUL) 'Warning: Fallopia multiflora may harm the liver in some people. Use under the supervision of a healthcare professional.'

2129

FARNESOL

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%.

2130

FAST GREEN FCF

E

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

2131

FENCHONE

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%.

2132

FENCHYL 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%.

2133

FENCHYL 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%.

2134

FENNEL BITTER SEED DRY

A, E, H

2135

FENNEL LEAF

E

2136

FENNEL OIL

A, E, H

Methyl chavicol is a mandatory component of fennel oil.

When the concentration of methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL, a restricted flow insert must fitted on the container, and the medicine requires the following warning statement on the medicine label:

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

The maximum daily dose must provide no more than 150 mg of fennel oil.

2137

FENNEL SWEET SEED DRY

A, E, H

2138

FENUGREEK

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%.

2139

FENUGREEK OIL

E

Fenugreek oil is 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%.

2140

FERRIC AMMONIUM CITRATE

A, E, H

When for internal use, iron is a mandatory component of ferric ammonium citrate.

The percentage of iron from ferric ammonium citrate should be calculated based on the molecular weight of ferric ammonium citrate.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

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

- (SUPMIN) 'For mineral (may state the mineral) supplementation.'

- (IRON1) 'Source of iron. Can assist in maintaining normal blood.'

- (IRON2) 'Source of iron. Can assist in maintaining normal blood. Blood tonic'

- (IRON5) 'Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.'

- (IRON6) 'May assist in the management of dietary iron deficiency.'

2141

FERRIC CHLORIDE

A, E, H

When for internal use, iron is a mandatory component of ferric chloride.

The percentage of Iron from ferric chloride should be calculated based on the molecular weight of ferric chloride.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

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

- (SUPMIN) 'For mineral (may state the mineral) supplementation.'

- (IRON1) 'Source of iron. Can assist in maintaining normal blood.'

- (IRON2) 'Source of iron. Can assist in maintaining normal blood. Blood tonic'

- (IRON5) 'Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.'

- (IRON6) 'May assist in the management of dietary iron deficiency.'

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

2142

FERRIC CHLORIDE HEXAHYDRATE

A, E, H

When for internal use, iron is a mandatory component of ferric chloride hexahydrate.

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

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

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

- (SUPMIN) 'For mineral (may state the mineral) supplementation.'

- (IRON1) 'Source of iron. Can assist in maintaining normal blood.'

- (IRON2) 'Source of iron. Can assist in maintaining normal blood. Blood tonic'

- (IRON5) 'Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.'

- (IRON6) 'May assist in the management of dietary iron deficiency.'

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

2143

FERRIC GLYCEROPHOSPHATE

A, E, H

When for internal use, iron is a mandatory component of ferric glycerophosphate.

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

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

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

- (SUPMIN) 'For mineral (may state the mineral) supplementation.'

- (IRON1) 'Source of iron. Can assist in maintaining normal blood.'

- (IRON2) 'Source of iron. Can assist in maintaining normal blood. Blood tonic'

- (IRON5) 'Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.'

- (IRON6) 'May assist in the management of dietary iron deficiency.'

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

2144

FERRIC OXIDE

E

2145

FERRIC PHOSPHATE

H

Only for use as an active homoeopathic ingredient.

2146

FERRIC PYROPHOSPHATE

A, H

When for internal use, iron is a mandatory component of ferric pyrophosphate.

The percentage of Iron from ferric pyrophosphate should be calculated based on the molecular weight of ferric pyrophosphate.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

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

- (SUPMIN) 'For mineral (may state the mineral) supplementation.'

- (IRON1) 'Source of iron. Can assist in maintaining normal blood.'

- (IRON2) 'Source of iron. Can assist in maintaining normal blood. Blood tonic'

- (IRON5) 'Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.'

- (IRON6) 'May assist in the management of dietary iron deficiency.'

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

2147

FERROSOFERRIC OXIDE

E

When used in undivided preparations for internal use and the concentration of iron oxide in the medicine is more than 1%, it is considered part of the total iron content.

When used in divided preparations for internal use, the concentration in the medicine must be no more than 10 mg per dosage unit.

2148

FERROSOFERRIC PHOSPHATE

H

Only for use as an active homoeopathic ingredient.

2149

FERROUS FUMARATE

A, H

When for internal use, iron is a mandatory component of ferrous fumarate.

The percentage of Iron from ferrous fumarate should be calculated based on the molecular weight of ferrous fumarate.

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

- (SUPMIN) 'For mineral (may state the mineral) supplementation.'

- (IRON1) 'Source of iron. Can assist in maintaining normal blood.'

- (IRON2) 'Source of iron. Can assist in maintaining normal blood. Blood tonic'

- (IRON5) 'Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.'

- (IRON6) 'May assist in the management of dietary iron deficiency.'

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

2150

FERROUS GLUCONATE

A, E, H

When for internal use, iron is a mandatory component of ferrous gluconate.

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

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

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

- (SUPMIN) 'For mineral (may state the mineral) supplementation.'

- (IRON1) 'Source of iron. Can assist in maintaining normal blood.'

- (IRON2) 'Source of iron. Can assist in maintaining normal blood. Blood tonic'

- (IRON5) 'Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.'

- (IRON6) 'May assist in the management of dietary iron deficiency.'

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

2151

FERROUS GLUCONATE DIHYDRATE

A, E, H

When for internal use, iron is a mandatory component of ferrous gluconate dihydrate.

The percentage of Iron from ferrous gluconate dihydrate should be calculated based on the molecular weight of ferrous gluconate dihydrate.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

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

- (SUPMIN) 'For mineral (may state the mineral) supplementation.'

- (IRON1) 'Source of iron. Can assist in maintaining normal blood.'

- (IRON2) 'Source of iron. Can assist in maintaining normal blood. Blood tonic'

- (IRON5) 'Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.'

- (IRON6) 'May assist in the management of dietary iron deficiency.'

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

2152

FERROUS IODIDE

H

Only for use as an active homoeopathic ingredient.

2153

FERROUS LACTATE TRIHYDRATE

A, E, H

When for internal use, iron is a mandatory component of ferrous lactate trihydrate.

The amount of iron in the active ingredient should be calculated based on the molecular weight of ferrous lactate trihydrate.

When used as an active ingredient, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than1%).

Divided preparations with a dose of more than 5mg of elemental iron per dosage unit and more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.

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

- (SUPMIN) 'For mineral (may state the mineral) supplementation.'

- (IRON1) 'Source of iron. Can assist in maintaining normal blood.'

- (IRON2) 'Source of iron. Can assist in maintaining normal blood. Blood tonic'

- (IRON5) 'Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.'

- (IRON6) 'May assist in the management of dietary iron deficiency.'

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

2154

FERROUS PHOSPHATE OCTAHYDRATE

A, E, H

When for internal use, iron is a mandatory component of ferrous phosphate octahydrate.

The amount of iron in the active ingredient should be calculated based on the molecular weight of ferrous phosphate octahydrate.

When used as an active ingredient, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5mg of elemental iron per dosage unit and more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.

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

- (SUPMIN) 'For mineral (may state the mineral) supplementation.'

- (IRON1) 'Source of iron. Can assist in maintaining normal blood.'

- (IRON2) 'Source of iron. Can assist in maintaining normal blood. Blood tonic'

- (IRON5) 'Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.'

- (IRON6) 'May assist in the management of dietary iron deficiency.'

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

2155

FERROUS PICRATE

H

Only for use as an active homoeopathic ingredient.

2156

FERROUS SULFATE

A, E, H

When used as an active ingredient, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5mg of elemental iron per dosage unit and more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.

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

- (SUPMIN) 'For mineral (may state the mineral) supplementation.'

- (IRON1) 'Source of iron. Can assist in maintaining normal blood.'

- (IRON2) 'Source of iron. Can assist in maintaining normal blood. Blood tonic'

- (IRON5) 'Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.'

- (IRON6) 'May assist in the management of dietary iron deficiency.'

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

2157

FERROUS SULFATE HEPTAHYDRATE

A, E, H

When for internal use, iron is a mandatory component of ferrous sulfate heptahydrate.

The percentage of iron from ferrous sulfate heptahydrate should be calculated based on the molecular weight of ferrous sulfate heptahydrate.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

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

- (SUPMIN) 'For mineral (may state the mineral) supplementation.'

- (IRON1) 'Source of iron. Can assist in maintaining normal blood.'

- (IRON2) 'Source of iron. Can assist in maintaining normal blood. Blood tonic'

- (IRON5) 'Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.'

- (IRON6) 'May assist in the management of dietary iron deficiency.'

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

2158

FERULA ASSA-FOETIDA

A, E, H

2159

FERULA FOETIDA

A, E, H

2160

FERULA GALBANIFLUA

A, E, H

2161

FERULA RUBRICAULIS

A, E, H

2162

FERULA SUMBUL

A, H

2163

FERULIC ACID

E

Only for use in topical medicines for dermal application.

2164

FESTUCA ELATIOR

A, H

2165

FEVERFEW HERB DRY

A, H

2166

FEVERFEW HERB POWDER

A, H

2167

FICUS CARICA

A, E, H

2168

FICUS PUMILA

A, H

2169

FIG

E

2170

FIG DRY

A, H

2171

FILIPENDULA ULMARIA

A, H

2172

FIR BALSAM 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%.

2173

FIR NEEDLE OIL CANADIAN

A, E

2174

FIR NEEDLE OIL SIBERIAN

A, E

2175

FIRMIANA SIMPLEX

A, E, H

2176

FISH OIL - RICH IN OMEGA-3 ACIDS

A

Only for use in oral medicines.

2177

FLEMINGIA MACROPHYLLA

A, H

2178

FLOUVE 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%.

2179

FLUORESCEIN SODIUM

E

2180

FOENICULUM VULGARE

A, E, H

When the plant preparation is oil or distillate, methyl chavicol is a mandatory component and the maximum daily dose must provide no more than 150 mg of the plant preparation.

When the plant preparation is oil or distillate and the concentration of methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL, a restricted flow insert must fitted on the container, and the medicine requires the following warning statement on the medicine label:

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

2181

FOLIC ACID

A

When for internal use, the maximum recommended daily dose must be no more than 500 micrograms of folic acid.

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 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’.

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

- (FOLIC1) 'Source of folic acid. Can assist in maintaining normal blood.'

- (VIT2) 'May assist in the management of dietary folate deficiency.'

- (FOLIC2) 'Source of folic acid. Can assist in maintaining normal blood. Blood tonic.'

2182

FOOD ORANGE 6

E

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

2183

FOOD ORANGE 7

E

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

2184

FOOD RED 13

E

Permitted for use only as a colour for topical use.

2185

FORMALDEHYDE/MELAMINE/TOSYLAMIDE COPOLYMER

E

Only for use in topical medicines for dermal application.

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

2186

FORMIC ACID

H

Only for use as an active homoeopathic ingredient.

2187

FORSYTHIA SUSPENSA

A, H

2188

FORTIFIED WINE

E

Ethanol is a mandatory component of fortified wine.

When the concentration of ethanol in the medicine is more than 3%, the medicine requires the following warning statement on the medicine label:

- (ETHAN) 'Contains ethanol or contains alcohol'.

2189

FRACTIONATED COCONUT OIL

E

2190

FRACTIONATED PALM KERNEL OIL

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.

2191

FRAGARIA CHILOENSIS

A, E, H

2192

FRAGARIA VESCA

A, E, H

2193

FRAGARIA VIRGINIANA

A, E, H

2194

FRAGARIA X ANANASSA

A, E, H

2195

FRANGULA BARK DRY

A, H

Glucofrangulins calculated as glucofrangulin A is a mandatory component of Frangula bark dry.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'

- (LAX2) 'Prolonged use may cause serious bowel problems'

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product [or words to that effect]'

- (S) 'If symptoms persist consult your healthcare practitioner [or words to that effect]'.

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water [or words to that effect]'

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

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

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

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'

- (LAX1) 'Drink plenty of water [or words to that effect]'

- (LAX2) 'Prolonged use may cause serious bowel problems'

2196

FRANGULA BARK POWDER

A, H

Glucofrangulins calculated as glucofrangulin A is a mandatory component of Frangula bark powder.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'

- (LAX2) 'Prolonged use may cause serious bowel problems'

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product [or words to that effect]'

- (S) 'If symptoms persist consult your healthcare practitioner [or words to that effect]'.

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water [or words to that effect]'

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

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

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

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'

- (LAX1) 'Drink plenty of water [or words to that effect]'

- (LAX2) 'Prolonged use may cause serious bowel problems'

2197

FRANGULA PURSHIANA

A, H

When for oral use, hydroxyanthracene derivatives calculated as cascaroside A is a mandatory component of Frangula purshiana.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'

- (LAX2) 'Prolonged use may cause serious bowel problems'

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product [or words to that effect]'

- (S) 'If symptoms persist consult your healthcare practitioner [or words to that effect]'.

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water [or words to that effect]'

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

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

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

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'

- (LAX1) 'Drink plenty of water [or words to that effect]'

- (LAX2) 'Prolonged use may cause serious bowel problems'

2198

FRAXINUS AMERICANA

A, H

2199

FRAXINUS CHINENSIS SUBSP. RHYNCHOPHYLLA

A, H

2200

FRAXINUS EXCELSIOR

A, H

The components Nuzhenide and secoiridoid glucoside GL3 are only available when the plant part is seed.

2201

FRAXINUS ORNUS

A, H

2202

FRITILLARIA CIRRHOSA

A, H

2203

FRITILLARIA THUNDBERGII

A, H

2204

FRITILLARIA VERTICILLATA

A, H

2205

FRUCTOOLIGOSACCHARIDES

A, E

2206

FRUCTOSE

A, E, H

2207

FUCUS VESICULOSUS

A, E, H

Iodine is a mandatory component of Fucus vesiculosus.

Only for external use when the concentration of available 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.

2208

FUMARIA OFFICINALIS

A, E, H

2209

FUMARIC ACID

E, H

Only for use as an active homoeopathic or excipient ingredient.

2210

FUMITORY HERB DRY

A, H

2211

FUMITORY HERB POWDER

A, H

2212

FURAMINTON

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%.

2213

FURFURAL

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%.

2214

FURFURYL 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%.

2215

FURFURYL ALCOHOL

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%.

2216

FURFURYL MERCAPTAN

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%.

2217

FUSEL 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%.

2218

GALBANUM 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%.

2219

GALBANUM PHENOL

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%.

2220

GALBANUM 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%.

2221

GALBANUM RESINOID

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%.

2222

GALEGA OFFICINALIS

A, H

2223

GALEOPSIS SEGETUM

A, H

2224

GALIUM APARINE

A, H

2225

GALIUM ODORATUM

A, H

2226

GALIUM PALUSTRE

A, H

2227

GALIUM VERUM

A, H

2228

GALL STONE

H

Only for use as an active homoeopathic ingredient.

2229

GALPHIMIA GLAUCA

A, H

2230

GAMMA-4-DIMETHYL-3-CYCLOHEXENE-1-PROPANOL

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%.

2231

GAMMA-BUTYROLACTONE

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%.

2232

GAMMA-CYCLODEXTRIN

E

2233

GAMMA-DECALACTONE

E

Permitted for use only:

(a) in topical medicines for dermal application; and

(b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

2234

GAMMA-DODECALACTONE

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%.

2235

GAMMA-HEPTALACTONE

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%.

2236

GAMMA-HEXALACTONE

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%.

2237

GAMMA-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%.

2238

GAMMA-LINOLEIC ACID

E

Only for use in topical medicines for dermal application.

2239

GAMMA-LINOLENIC ACID

E

2240

GAMMA-N-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%.

2241

GAMMA-NONALACTONE

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%.

2242

GAMMA-OCTALACTONE

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%.

2243

GAMMA-TERPINENE

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%.

2244

GAMMA-TOCOPHEROL

E

2245

GAMMA-UNDECALACTONE

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%.

2246

GAMMA-VALEROLACTONE

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%.

2247

GANODERMA LUCIDUM

A, E, H

2248

GARCINIA GUMMI-GUTTA

A

Only for use in oral medicines.

Must be obtained from the rind of the fruit only.

Must not contain any directions for use for children or pregnant or lactating women.

2249

GARCINIA QUAESITA

A, H

2250

GARDEN BEAN

E

2251

GARDENIA JASMINOIDES

A, E

2252

GARDENIA TAHITENSIS FLOWER EXTRACT

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 0.002%

2253

GARLIC BULB DRY

A, E, H

2254

GARLIC BULB FRESH

A, H

2255

GARLIC BULB POWDER

A, E, H

2256

GARLIC CLOVE POWDER

A, H

2257

GARLIC OIL

A, E, H

2258

GASTRODIA ELATA

A, H

2259

GAULTHERIA PROCUMBENS

A, E, H

Methyl salicylate is a mandatory component of Gaultheria procumbens and must be declared in the application.

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

When the concentration of Methyl salicylate in a liquid preparation is more than 5%, and the dosage form is other than spray, the medicine requires child resistant packaging.

When the concentration of Methyl salicylate in a liquid preparation is more than 5%, and the dosage form is spray, the medicine does not require child resistant packaging 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.

2260

GELATIN

A, E

2261

GELIDIUM AMANSII

A, H

Iodine is a mandatory component of Gelidium amansii.

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.

2262

GELLAN GUM

E

2263

GELSEMIUM DRY

A, H

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

2264

GELSEMIUM POWDER

A, H

2265

GELSEMIUM SEMPERVIRENS

A, H

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

2266

GENET 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%.

2267

GENTIAN DRY

A, H

2268

GENTIAN POWDER

A, H

2269

GENTIANA LUTEA

A, E, H

2270

GENTIANA MACROPHYLLA

A, H

2271

GENTIANA RHODANTHA

A, H

2272

GENTIANA SCABRA

A, H

2273

GENTIANELLA AMARELLA

A, H

2274

GERANIAL

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%.

2275

GERANIC ACID

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%.

2276

GERANIOL

E

Permitted for use only:

(a) in topical medicines for dermal application; and

(b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

2277

GERANIUM

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%.

2278

GERANIUM MACULATUM

A, E, H

2279

GERANIUM OIL

A, E, H

2280

GERANIUM OIL SAPONIFIED

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%.

2281

GERANIUM OIL TERPENELESS

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%.

2282

GERANIUM ROBERTIANUM

A, E, H

2283

GERANIUM ROSE 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%.

2284

GERANIUM SIBIRICUM

A, E, H

2285

GERANYL 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%.

2286

GERANYL ACETONE

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%.

2287

GERANYL BUTYRATE

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%.

2288

GERANYL CROTONATE

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%.

2289

GERANYL ETHYL ETHER

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%.

2290

GERANYL 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%.

2291

GERANYL 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%.

2292

GERANYL ISOVALERATE

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%.

2293

GERANYL NITRILE

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%.

2294

GERANYL 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%.

2295

GERANYL TIGLATE

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%.

2296

GEUM RIVALE

A, H

2297

GEUM URBANUM

A, H

2298

GHATTI GUM

A, E, H

2299

GIGARTINA MAMILLOSA

A, H

Iodine is a mandatory component of Gigartina mamillosa.

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.

2300

GINGER DRY

A, E, H

2301

GINGER OIL

A, E, H

2302

GINGER OLEORESIN

E

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

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

2303

GINGER POWDER

A, E, H

2304

GINKGO BILOBA

A, E, H

The Ginkgo biloba leaf extract used in the manufacture of this medicine must comply with the requirement of Identification Test B of the monograph Powdered Ginkgo Extract in the United States Pharmacopeia 32 - National Formulary 27 (USP32-NF27), as in force or existing from time to time. This condition does not apply to powdered or dried leaf.

2305

GLACIAL ACETIC ACID

E, H

The concentration in the medicine must be no more than 1.5%.

2306

GLECHOMA HEDERACEA

A, H

2307

GLECHOMA LONGITUBA

A, H

2308

GLEDITSIA AUSTRALIS

A, H

2309

GLEDITSIA SINENSIS

A, H

2310

GLEHNIA LITTORALIS

A, H

2311

GLORIOSA SUPERBA

A, H

Colchicine is a mandatory component of Gloriosa superba and must be declared in the application.

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

2312

GLUCOMANNAN

E

Only for use when the dosage form is other than tablet.

2313

GLUCONOLACTONE

E

2314

GLUCOSAMINE HYDROCHLORIDE

A, E

When derived from seafood, the medicine requires the following warning statement on the medicine label:

- (SFOOD) 'Derived from seafood'.

2315

GLUCOSAMINE SULFATE

A

When derived from seafood, the medicine requires the following warning statement on the medicine label:

- (SFOOD) 'Derived from seafood'.

2316

GLUCOSAMINE SULFATE POTASSIUM CHLORIDE

A

Potassium chloride is a mandatory component of glucosamine sulfate potassium chloride.

When derived from seafood, the medicine requires the following warning statement on the medicine label:

- (SFOOD) 'Derived from seafood'.

When for oral use, the medicine requires the following warning statement on the medicine label:

- (POTAS) ‘Contains [amount of potassium in milligrams] mg of potassium. If you have kidney disease or are taking heart or blood pressure medicines - consult your doctor or pharmacist before use. Keep out of reach of children.’

2317

GLUCOSAMINE SULFATE SODIUM CHLORIDE

A

When derived from seafood, the medicine requires the following warning statement on the medicine label:

- (SFOOD) 'Derived from seafood'.

2318

GLUCOSE

A, E, H

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).

2319

GLUCOSE GLUTAMATE

E

Only for use in topical medicines for dermal application.

2320

GLUCOSE MONOHYDRATE

A, E, H

When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose monohydrate, 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).

2321

GLUCOSYLRUTIN

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%.

2322

GLUTAMIC ACID

A, E

Only for use in topical medicines for dermal application.

2323

GLUTAMIC ACID HYDROCHLORIDE

A, E, H

2324

GLUTAMINE

A, E, H

2325

GLUTARAL

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%.

2326

GLUTATHIONE

A, E

When used as an active ingredient, glutathione can only be used in medicines with an oral route of administration and must be indicated for use in adults only and not in pregnant or lactating women.

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

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

- (ADULT) 'Adults only' (or words to that effect).

2327

GLUTEN-FREE WHEAT STARCH

E

2328

GLYCERETH-26

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 7%.

2329

GLYCEROL

A, E

When used as an active ingredient, it is only for use in topical medicines for dermal application.

When used as an excipient for oral use, if the quantity of sugar alcohols per maximum recommended daily dose is more than 2 g, 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]’.

2330

GLYCEROL ESTER OF PARTIALLY HYDROGENATED GUM ROSIN

E

Only for use when the dosage form is 'chewing gum'.

Must comply with:

a) the Glycerol Ester of Partially Hydrogenated Gum Rosin monograph in the Food Chemicals Codex published by the United States Pharmacopeial Convention, as in force or existing from time to time; and

b) the requirements for residual solvents and catalysts in the British Pharmacopoeia or the United States Pharmacopeia-National Formulary, as in force or existing from time to time.

2331

GLYCERYL BEHENATE

E

Behenic acid is a mandatory component of glyceryl behenate.

When for oral ingestion, the maximum recommended daily dose must not provide more than 383.5 milligrams of behenic acid.

In medicines for topical use, the concentration of glyceryl behenate must be no more than 5%.

2332

GLYCERYL CAPRYLATE

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%.

2333

GLYCERYL DIISOSTEARATE

E

For use in topical medicines for dermal application.

2334

GLYCERYL DILAURATE

E

Only for use in topical medicines for dermal application.

2335

GLYCERYL DIOLEATE

E

Only for use in topical medicines for dermal application.

2336

GLYCERYL DISTEARATE

E

Only for use in topical medicines for dermal application.

2337

GLYCERYL GLUCOSIDE

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%.

2338

GLYCERYL ISOSTEARATE

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 5.5%.

2339

GLYCERYL LAURATE

E

Only for use in topical medicines for dermal application.

2340

GLYCERYL LINOLEATE

E

Only for use in topical medicines for dermal application.

2341

GLYCERYL LINOLENATE

E

Only for use in topical medicines for dermal application.

2342

GLYCERYL MONOOLEATE

E

2343

GLYCERYL MONOSTEARATE

E

2344

GLYCERYL MYRISTATE

E

Only for use in topical medicines for dermal application.

2345

GLYCERYL OLEATE CITRATE

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 4% of the formulation.

2346

GLYCERYL PALMITO-STEARATE

E

2347

GLYCERYL POLYACRYLATE

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 0.15%.

2348

GLYCERYL POLYMETHACRYLATE

E

Only for use in topical medicines for dermal application.

2349

GLYCERYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

2350

GLYCERYL ROSINATE

E

Only for use when the dosage form is 'chewing gum'.

Must comply with:

a) the Glycerol Ester of Gum Rosin monograph in the Food Chemicals Codex published by the United States Pharmacopeial Convention, as in force or existing from time to time; and

b) the requirements for residual solvents and catalysts in the British Pharmacopoeia or the United States Pharmacopeia National Formulary, as in force or existing from time to time.

2351

GLYCERYL SORBITAN OLEOSTEARATE

E

Only for use in topical medicines for dermal application.

2352

GLYCERYL STARCH

E

Only for use in topical medicines for dermal application.

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

The residual levels of epichlorohydrin are to be kept below the level of detection.

2353

GLYCERYL STEARATE CITRATE

E

Only for use in topical medicines for dermal application.

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

2354

GLYCERYL TRIACETYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 6%.

2355

GLYCERYL TRIACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

2356

GLYCERYL TRINITRATE

H

Only for use as an active homoeopathic ingredient.

2357

GLYCERYL UNDECYLENATE

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 of glyceryl undecylenate in a medicine must be no more than 3%.

2358

GLYCINE

A, E

2359

GLYCINE MAX

A, E, H

2360

GLYCOGEN

E

Only for use in topical medicines for dermal application.

2361

GLYCOL DISTEARATE

E

Only for use in topical medicines for dermal application.

2362

GLYCOLIC ACID

E

Only for use in topical medicines for dermal application.

Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose.

When present as an excipient in sunscreens, the concentration in the medicine must be no more than 5%.

When used as an excipient ingredient in other medicines the concentration in the medicine must be no more than 20%.

If the concentration is more than 5% but no more than 20%, the pH of the medicine must be 3.5 or greater.

2363

GLYCYRRHIZA GLABRA

A, E, H

2364

GLYCYRRHIZA SPECIES

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%.

2365

GLYCYRRHIZA URALENSIS

A, E, H

2366

GLYCYRRHIZINIC ACID

E

2367

GNAPHALIUM AFFINE

A, H

2368

GNAPHALIUM POLYCEPHALUM

A, H

2369

GNAPHALIUM ULIGINOSUM

A, H

2370

GOAT

H

Only for use as an active homoeopathic ingredient.

2371

GOAT MILK

E

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).

2372

GOLD

E, H

Only for use as an active homoeopathic or excipient ingredient.

2373

GOLD CHLORIDE

H

Only for use as an active homoeopathic ingredient.

2374

GOLDEN ROD HERB DRY

A, E, H

2375

GOLDEN SEAL ROOT DRY

A, H

2376

GOLDEN SEAL ROOT POWDER

A, H

2377

GOLDEN SYRUP

E

Sucrose is a mandatory component of Golden syrup when the route of administration of the medicine is oral or sublingual.

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).

2378

GOMPHRENA GLOBOSA

A, H

2379

GOOSEBERRY

E

2380

GOSSYPIUM HERBACEUM

A, E, H

2381

GRAPE

E

2382

GRAPE SEED OIL

E

2383

GRAPE WINE RED

E

Ethanol is a mandatory component of Grape wine red.

When the concentration of ethanol in the medicine is more than 3%, the medicine requires the following warning statement on the medicine label:

- (ETHAN) ‘Contains ethanol’ or ‘contains alcohol’

2384

GRAPE WINE SHERRY

E

Ethanol is a mandatory component of Grape wine sherry.

When the concentration of ethanol in the medicine is more than 3%, the medicine requires the following warning statement on the medicine label:

- (ETHAN) ‘Contains ethanol’ or ‘contains alcohol’

2385

GRAPE WINE WHITE

E

Ethanol is a mandatory component of Grape wine white.

When the concentration of ethanol in the medicine is more than 3%, the medicine requires the following warning statement on the medicine label:

- (ETHAN) ‘Contains ethanol’ or ‘contains alcohol’

2386

GRAPEFRUIT

E

2387

GRAPEFRUIT 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%.

2388

GRAPEFRUIT OIL COLDPRESSED

A, E, H

2389

GRAPEFRUIT OIL CONCENTRATE

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%.

2390

GRAPEFRUIT 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%.

2391

GRAPEFRUIT 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%.

2392

GRAPHITE

H

Only for use as an active homoeopathic ingredient.

2393

GRATIOLA LINIFOLIA

A, H

2394

GREATER NETTLE HERB DRY

A, H

2395

GREATER NETTLE HERB POWDER

A, H

2396

GREATER NETTLE ROOT DRY

A, H

2397

GREATER NETTLE ROOT POWDER

A, H

2398

GREEN LIPPED MUSSEL

A

2399

GREEN LIPPED MUSSEL DRIED

A

2400

GREEN LIPPED MUSSEL OIL

A

2401

GREEN S

E

Only for use as a colour in topical and oral medicines.

2402

GRIFOLA FRONDOSA

A

When the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:                                                                                                                                                      

 -(WARF) 'Do not take while on warfarin therapy without medical advice.'

2403

GRINDELIA CAMPORUM

A, H

2404

GRINDELIA ROBUSTA

A, H

2405

GRISALVA

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%.

2406

GROUND IVY HERB DRY

A, H

2407

GROUND IVY HERB POWDER

A, H

2408

GUAIAC WOOD 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%.

2409

GUAIACOL

E

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

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

2410

GUAIACUM OFFICINALE

A, E, H

2411

GUAIACUM RESIN

A, E, H

2412

GUAIACUM SANCTUM

A, H

2413

GUAIACWOOD 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 than 1%.

2414

GUAIENE

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%.

2415

GUAIYL 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%.

2416

GUANINE

E

Only for use as an excipient in topical medicines for dermal application.

2417

GUANOSINE

E

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

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

2418

GUAR GALACTOMANNAN

A

When for oral use:

(a) the maximum daily dose must provide no more than 25 g of guar galactomannan;

(b) the medicine requires the following dosage instructions:

- (FIBRE) 'The dose of fibre should be increased gradually. Fluid intake should be increased with an increasing dose of fibre.' (or words to that effect)

(c) when the dosage form is a powder preparation, the medicine requires the following dosage instructions:

- (DNTPOW) 'Do not take powder alone. Mix with food or fluid.' (or words to that effect).

2419

GUAR GUM

A, E, H

2420

GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE

E

Only for use as an excipient in topical medicines for dermal application.

2421

GUAREA RUSBYI

A, H

2422

GUAVA

E

2423

GURJUN BALSAM

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%.

2424

GYMNADENIA NIGRA

A

2425

GYMNEMA SYLVESTRE

A, H

2426

GYMNOCLADUS DIOICA

A, H

2427

GYNOSTEMMA PENTAPHYLLUM

A

The herbal substance must be derived from the aerial parts of the vine only (stem, leaves, fruit).

2428

GYNURA JAPONICA

A, H

2429

HAHNEMANN'S SOLUBLE MERCURY

H

Only for use as an active homoeopathic ingredient.

2430

HALIBUT-LIVER OIL

A, E

Colecalciferol and Vitamin A are mandatory components of Halibut-liver oil.

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

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

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

When divided preparations for internal use in adults contain more than 33 micrograms of Retinol Equivalents per dosage unit, the medicine requires the following warning statements on the medicine label:

- (VITA2) ‘WARNING: If you are pregnant - or considering becoming pregnant - do not take Vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].’ NOTE: Position this warning at the beginning of the directions for use.

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

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

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

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.

2431

HAMAMELIS LEAF DRY

A, H

2432

HAMAMELIS LEAF POWDER

A, H

2433

HAMAMELIS VIRGINIANA

A, E, H

2434

HAMAMELIS WATER

A, E, H

2435

HANDROANTHUS HEPTAPHYLLUS

A, H

2436

HANDROANTHUS IMPETIGINOSUS

A, E, H

2437

HARD FAT

E

2438

HARD PARAFFIN

E

2439

HARICOT BEAN

E

2440

HARPAGOPHYTUM PROCUMBENS

A, E, H

2441

HARUNGANA MADAGASCARIENSIS

A, H

2442

HAZEL NUT

E

2443

HAZEL NUT OIL

E

2444

HEAVY KAOLIN

E

2445

HEAVY 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 Heavy magnesium oxide.

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

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

2446

HECTORITE

E

Only for use in topical medicines for dermal application.

2447

HEDEOMA PULEGIOIDES

A

2448

HEDERA HELIX

A, H

Emetine is a mandatory component of Hedera helix.

The concentration of emetine in the medicine must be no more than 0.2%.

2449

HEDTA

E

Only for use as an excipient in topical medicines for dermal application.

2450

HEKLA LAVA

H

Only for use as an active homoeopathic ingredient.

2451

HELESTRALIS

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%.

2452

HELIANTHEMUM NUMMULARIUM

A, H

2453

HELIANTHUS ANNUUS

A, E, H

2454

HELIANTHUS TUBEROSUS

A, H

2455

HELICHRYSUM ANGUSTIFOLIUM

A, E, H

2456

HELICHRYSUM ARENARIUM

A, H

2457

HELIOTROPYL 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%.

2458

HELLEBORUS NIGER

A, H

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

2459

HELLEBORUS VIRIDIS

A, H

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

2460

HELONIAS RHIZOME DRY

A, H

2461

HELONIAS RHIZOME POWDER

A, H

2462

HEMIDESMUS INDICUS

A, E, H

2463

HEPTANAL

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%.

2464

HEPTANAL DIMETHYL 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%.

2465

HEPTANOIC 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%.

2466

HEPTENAL

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%.

2467

HEPTYL 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%.

2468

HEPTYL 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%.

2469

HEPTYL UNDECYLENATE

E

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

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

2470

HERACLEUM HEMSLEYANUM

A, H

2471

HERNIARIA GLABRA

A, H

2472

HESPERIDIN

A, E

2473

HEX-3-ENYL 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%.

2474

HEXAHYDRO-4,7-METHANOINDEN-6-YL PIVALATE

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%.

2475

HEXAMETHYLINDANOPYRAN

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%.

2476

HEXAN-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%.

2477

HEXANE

E

The concentration of the medicine must be no more than 0.029%.

When used for a route of administration other than topical, the residual solvent limit for Hexane is 2.9 mg per recommended daily dose.

2478

HEXANOATE

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%.

2479

HEXANOIC 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%.

2480

HEXASODIUM FYTATE

E

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

The concentration of Hexasodium fytate in the medicine must be no more than 1.0 %.

2481

HEXENAL

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%.

2482

HEXYL 2-METHYLBUTYRATE

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%.

2483

HEXYL 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%.

2484

HEXYL BUTYRATE

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%.

2485

HEXYL 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%.

2486

HEXYL FORMATE

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%.

2487

HEXYL ISOBUTYRATE

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%.

2488

HEXYL ISOVALERATE

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%.

2489

HEXYL LAURATE

E

Only for use as an excipient in topical medicines for dermal application.

2490

HEXYL NICOTINATE

E

2491

HEXYL SALICYLATE

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%.

2492

HEXYL TIGLATE

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%.

2493

HEXYLDECANOL

E

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

The concentration of the medicine must be no more than 3%.

2494

HEXYLENE GLYCOL

E

Only for use as an excipient in topical medicines for dermal application.

2495

HIBISCUS ESCULENTUS

A, H

2496

HIBISCUS MUTABILIS

A, H

2497

HIBISCUS ROSA-SINENSIS

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%.

2498

HIBISCUS SABDARIFFA

A, E, H

2499

HIERACIUM PILOSELLA

A, H

2500

HIGH AMYLOSE MAIZE STARCH

A, E, H

2501

HIGH CHROMIUM YEAST

A, E

Chromium is a mandatory component of high chromium yeast.

The maximum daily dose of chromium from high chromium yeast must be no more than 50 micrograms as high chromium yeast is considered to be an organic form of chromium.

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

2502

HIGH FRUCTOSE MAIZE SYRUP

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%.

2503

HIGH MOLYBDENUM YEAST

A, E

Molybdenum is a mandatory component of high molybdenum yeast.

The maximum daily dose of molybdenum from high molybdenum yeast must be no more than 62.5 micrograms.

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

2504

HIGH SELENIUM YEAST

A

When for oral or sublingual use, selenium is a mandatory component of high selenium yeast.

Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose.

When for oral use, the medicine requires the following warning statement on the medicine label:

- (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded'.

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

2505

HIMATANTHUS LANCIFOLIUS

A, E, H

2506

HIPPOPHAE RHAMNOIDES

A, E, H

2507

HIRSCHFELDIA INCANA

A, H

Allyl isothiocyanate is a mandatory component of Hirschfeldia incana when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

2508

HISTAMINE DIHYDROCHLORIDE

H

Only for use as an active homoeopathic ingredient. 

2509

HISTIDINE

A

2510

HISTIDINE HYDROCHLORIDE

A, E, H

2511

HO 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 1%.

2512

HO WOOD 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%.

2513

HOLCUS LANATUS

A, H

2514

HOLY THISTLE HERB DRY

A, H

2515

HOLY THISTLE HERB POWDER

A, H

2516

HOMALOMENA OCCULTA

A, H

2517

HOMOSALATE

A, E

Only for use as an active ingredient in sunscreens.

In other products, only for use as an excipient in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye.

The concentration of homosalate in the medicine must be no more than 15%.

2518

HONEY

A, E

When the route of administration is oral, the medicine requires the following warning statement on the medicine label:

- (BABY2) 'Not suitable for infants under the age of twelve months' (or words to that effect).

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).

2519

HONEY BEE

H

Only for use as an active homoeopathic ingredient.

2520

HONEY EXTRACT

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 of the medicine must be no more than 1%.

2521

HONEY POWDER

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%.

2522

HOP STROBILE DRY

A, H

2523

HOP STROBILE POWDER

A, H

2524

HOPS OIL

A, E, H

2525

HORDEUM DISTICHON

A, E, H

Gluten is a mandatory component when the plant part is seed, and must be declared in the application 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.

2526

HORDEUM VULGARE

A, E, H

Gluten is a mandatory component when the plant part is seed, and must be declared in the application 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.

2527

HOREHOUND 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%.

2528

HORSE RADISH

E, H

Volatile oil components (of Armoracia rusticana) is a mandatory component of Horse radish.

The maximum recommended daily dose must be no more than 20 mg of volatile oil components (of Armoracia rusticana).

2529

HOTTONIA PALUSTRIS

A, H

2530

HOUTTUYNIA CORDATA

A, H

2531

HOVENIA DULCIS

A, H

2532

HUMULUS LUPULUS

A, E, H

2533

HYALURONIC ACID

E

Only for use as an excipient in topical medicines for dermal application.

2534

HYDNOCARPUS ANTHELMINTICA

A, H

When the medicine is for other than topical use and the plant part is seed, the maximum recommended daily dose must be no more than 1mg of the equivalent dry seed.

2535

HYDRANGEA ARBORESCENS

A, H

2536

HYDRANGEA PANICULATA

A, H

2537

HYDRASTIS CANADENSIS

A, E, H

2538

HYDRATED SILICA

E

Only for use when the route of administration is other than inhalation.

2539

HYDROCHLORIC ACID

E

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

2540

HYDROCOTYLE UMBELLATA

A, H

2541

HYDROFLUORIC ACID

H

Only for use as an active homoeopathic ingredient. 

2542

HYDROGEN CYANIDE

H

Only for use as an active homoeopathic ingredient. 

2543

HYDROGEN PEROXIDE

A, E

When used as the active ingredient, it is only for use in topical medicines for dermal application.

The concentration of hydrogen peroxide in the medicine must be no more than 3%.

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.

2544

HYDROGENATED BUTYLENE/ETHYLENE/STYRENE COPOLYMER

E

Only for use in topical medicines for dermal application.

The combined concentration of hydrogenated butylene/ethylene/stryene copolymer and hydrogenated ethylene/propylene/styrene copolymer in the medicine must be no more than 9%.

2545

HYDROGENATED C6-14 OLEFIN POLYMERS

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 7%.

2546

HYDROGENATED CASTOR OIL

E

2547

HYDROGENATED COCO-GLYCERIDES

E

Only for use 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 3%.

2548

HYDROGENATED COCONUT OIL

E

2549

HYDROGENATED COTTONSEED OIL

E

2550

HYDROGENATED DIMER DILINOLEYL/DIMETHYLCARBONATE COPOLYMER

E

Only for use 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 4% in the product.

2551

HYDROGENATED ETHYLENE/PROPYLENE/STYRENE COPOLYMER

E

The combined concentration of hydrogenated ethylene/propylene/styrene copolymer must be no more than 9%.

2552

HYDROGENATED LANOLIN

E

2553

HYDROGENATED LECITHIN

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%.

2554

HYDROGENATED PALM GLYCERIDES

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 1.6%.

2555

HYDROGENATED PALM KERNEL OIL

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 1.2%.

2556

HYDROGENATED PALM OIL

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%.

Polycyclic aromatic hydrocarbons must be kept below the level of detection.

2557

HYDROGENATED POLYDECENE

E

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

2558

HYDROGENATED POLYISOBUTENE

E

Only for use in topical medicines for dermal application.

2559

HYDROGENATED SOYA OIL

E

2560

HYDROGENATED TALLOW GLYCERIDE

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%.

2561

HYDROGENATED VEGETABLE OIL

E

2562

HYDROLIAC

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%.

2563

HYDROLYSED ADANSONIA DIGITATA LEAF POLYSACCHARIDES

E

Only for use 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 0.01%

2564

HYDROLYSED ALGIN

E

Only for use 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 0.02%

2565

HYDROLYSED CEREAL SOLIDS

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%.

2566

HYDROLYSED COLLAGEN

E

2567

HYDROLYSED ELASTIN

E

Only for use in topical medicines for dermal application.

2568

HYDROLYSED GELATIN

A, E

2569

HYDROLYSED GLYCOSAMINOGLYCANS

E

Only for use in topical medicines for dermal application.

2570

HYDROLYSED JOJOBA ESTERS

E

Only for use 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 5%.

2571

HYDROLYSED 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%.

2572

HYDROLYSED MAIZE STARCH

E

2573

HYDROLYSED MILK PROTEIN

E

2574

HYDROLYSED RICE

A, E, H

2575

HYDROLYSED RICE PROTEIN

E

Only for use 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 0.125%.

2576

HYDROLYSED SOY PROTEIN

E

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

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

2577

HYDROLYSED VEGETABLE PROTEIN

E

2578

HYDROLYSED WHEAT PROTEIN

E

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.

2579

HYDROLYSED WHEAT PROTEIN/PVP CROSSPOLYMER

E

Only for use 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 1.2%.

2580

HYDROLYSED YEAST PROTEIN

E

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

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

2581

HYDROQUINONE DIMETHYL ETHER

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%.

2582

HYDROUS WOOL FAT

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.

2583

HYDROXOCOBALAMIN

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.’

2584

HYDROXYACETOPHENONE

E

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

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

2585

HYDROXYAPATITE

A, E

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

- (SCI-BONDIOP-PR) 'A diet deficient in calcium can lead to osteoporosis in later life'

- (SCI-NUMCALE-AP) 'Calcium may help prevent osteoporosis when dietary intake is inadequate'

- (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.'

2586

HYDROXYCITRATE COMPLEX

A

Hydroxycitrate complex must contain one or more of the three salts (calcium, sodium or potassium hydroxycitrate) of hydroxycitric acid.

2587

HYDROXYCITRIC ACID

A

2588

HYDROXYCITRONELLAL

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%.

2589

HYDROXYCITRONELLAL 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%.

2590

HYDROXYCITRONELLAL-METHYLANTHRANILATE

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%.

2591

HYDROXYCITRONELLOL

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%.

2592

HYDROXYETHYL CETEARAMIDOPROPYLDIMONIUM CHLORIDE

E

Only for use 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 0.1%.

2593

HYDROXYETHYL UREA

E

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

The concentration must be no more than 1%.