2129

FABIANA IMBRICATA

A,H

2130

FAGOPYRUM ESCULENTUM

A,H

2131

FAGUS GRANDIFOLIA

A,H

2132

FAGUS SYLVATICA

A,H

2133

FALLOPIA JAPONICA

A,E,H

2134

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.'

2135

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%.

2136

FAST GREEN FCF

E

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

2137

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%.

2138

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%.

2139

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%.

2140

FENNEL BITTER SEED DRY

A,E,H

2141

FENNEL LEAF

E

2142

FENNEL OIL

A,E,H

2143

FENNEL SWEET SEED DRY

A,E,H

2144

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%.

2145

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%.

2146

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.'

2147

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.'

2148

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.'

2149

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.'

2150

FERRIC OXIDE

E

2151

FERRIC PHOSPHATE

H

Only for use as an active homoeopathic ingredient.

2152

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.'

2153

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.

2154

FERROSOFERRIC PHOSPHATE

H

Only for use as an active homoeopathic ingredient.

2155

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.'

2156

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.'

2157

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 dehydrate 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.'

2158

FERROUS IODIDE

H

Only for use as an active homoeopathic ingredient.

2159

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.'

2160

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.'

2161

FERROUS PICRATE

H

Only for use as an active homoeopathic ingredient.

2162

FERROUS SULFATE

A,E,H

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

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

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.'

2163

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.'

2164

FERULA ASSA-FOETIDA

A,E,H

2165

FERULA FOETIDA

A,E,H

2166

FERULA GALBANIFLUA

A,E,H

2167

FERULA RUBRICAULIS

A,E,H

2168

FERULA SUMBUL

A,H

2169

FERULIC ACID

E

Only for use in topical medicines for dermal application.

2170

FESTUCA ELATIOR

A,H

2171

FEVERFEW HERB DRY

A,H

2172

FEVERFEW HERB POWDER

A,H

2173

FICUS CARICA

A,E,H

2174

FICUS PUMILA

A,H

2175

FIG

E

2176

FIG DRY

A,H

2177

FILIPENDULA ULMARIA

A,H

2178

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%.

2179

FIR NEEDLE OIL CANADIAN

A,E

2180

FIR NEEDLE OIL SIBERIAN

A,E

2181

FIRMIANA SIMPLEX

A,E,H

2182

FISH OIL - RICH IN OMEGA-3 ACIDS

A

Only for use in oral medicines.

2183

FLEMINGIA MACROPHYLLA

A,H

2184

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%.

2185

FLUORESCEIN SODIUM

E

2186

FOENICULUM VULGARE

A,E,H

2187

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.'

2188

FOOD ORANGE 6

E

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

2189

FOOD ORANGE 7

E

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

2190

FOOD RED 13

E

Permitted for use as a colour for topical use.

2191

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%.

2192

FORMIC ACID

H

Only for use as an active homoeopathic ingredient.

2193

FORSYTHIA SUSPENSA

A,H

2194

FORTIFIED WINE

E

Ethanol is a mandatory component of Wine - fortified.

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'

2195

FRACTIONATED COCONUT OIL

E

2196

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.

2197

FRAGARIA CHILOENSIS

A,E,H

2198

FRAGARIA VESCA

A,E,H

2199

FRAGARIA VIRGINIANA

A,E,H

2200

FRAGARIA X ANANASSA

A,E,H

2201

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'

2202

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'

2203

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'

2204

FRAXINUS AMERICANA

A,H

2205

FRAXINUS CHINENSIS SUBSP. RHYNCHOPHYLLA

A,H

2206

FRAXINUS EXCELSIOR

A,H

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

2207

FRAXINUS ORNUS

A,H

2208

FRITILLARIA CIRRHOSA

A,H

2209

FRITILLARIA THUNDBERGII

A,H

2210

FRITILLARIA VERTICILLATA

A,H

2211

FRUCTOOLIGOSACCHARIDES

A,E

2212

FRUCTOSE

A,E,H

2213

FUCUS VESICULOSUS

A,E,H

Iodine is a mandatory component of Fucus vesiculosus.

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.

2214

FUMARIA OFFICINALIS

A,E,H

2215

FUMARIC ACID

E,H

Only for use as an active homoeopathic or excipient ingredient.

2216

FUMITORY HERB DRY

A,H

2217

FUMITORY HERB POWDER

A,H

2218

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%.

2219

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%.

2220

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%.

2221

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%.

2222

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%.

2223

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%.

2224

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%.

2225

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%.

2226

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%.

2227

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%.

2228

GALEGA OFFICINALIS

A,H

2229

GALEOPSIS SEGETUM

A,H

2230

GALIUM APARINE

A,H

2231

GALIUM ODORATUM

A,H

2232

GALIUM PALUSTRE

A,H

2233

GALIUM VERUM

A,H

2234

GALL STONE

H

Only for use as an active homoeopathic ingredient.

2235

GALPHIMIA GLAUCA

A,H

2236

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%.

2237

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%.

2238

GAMMA-CYCLODEXTRIN

E

2239

GAMMA-DECALACTONE

E

Only for use in topical medicines for dermal application.

2240

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%.

2241

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%.

2242

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%.

2243

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%.

2244

GAMMA-LINOLEIC ACID

E

Only for use in topical medicines for dermal application.

2245

GAMMA-LINOLENIC ACID

E

2246

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%.

2247

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%.

2248

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%.

2249

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%.

2250

GAMMA-TOCOPHEROL

E

2251

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%.

2252

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%.

2253

GANODERMA LUCIDUM

A,E,H

2254

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.

2255

GARCINIA QUAESITA

A,H

2256

GARDEN BEAN

E

2257

GARDENIA JASMINOIDES

A,E

2258

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%

2259

GARLIC BULB DRY

A,E,H

2260

GARLIC BULB FRESH

A,H

2261

GARLIC BULB POWDER

A,E,H

2262

GARLIC CLOVE POWDER

A,H

2263

GARLIC OIL

A,E,H

2264

GASTRODIA ELATA

A,H

2265

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.

2266

GELATIN

A,E

2267

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.

2268

GELLAN GUM

E

2269

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%.

2270

GELSEMIUM POWDER

A,H

2271

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%.

2272

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%.

2273

GENTIAN DRY

A,H

2274

GENTIAN POWDER

A,H

2275

GENTIANA LUTEA

A,E,H

2276

GENTIANA MACROPHYLLA

A,H

2277

GENTIANA RHODANTHA

A,H

2278

GENTIANA SCABRA

A,H

2279

GENTIANELLA AMARELLA

A,H

2280

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%.

2281

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%.

2282

GERANIOL

E

Only for use in topical medicines for dermal application.

2283

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%.

2284

GERANIUM MACULATUM

A,E,H

2285

GERANIUM OIL

A,E,H

2286

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%.

2287

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%.

2288

GERANIUM ROBERTIANUM

A,E,H

2289

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%.

2290

GERANIUM SIBIRICUM

A,E,H

2291

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%.

2292

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%.

2293

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%.

2294

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%.

2295

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%.

2296

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%.

2297

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%.

2298

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%.

2299

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%.

2300

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%.

2301

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%.

2302

GEUM RIVALE

A,H

2303

GEUM URBANUM

A,H

2304

GHATTI GUM

A,E,H

2305

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.

2306

GINGER DRY

A,E,H

2307

GINGER OIL

A,E,H

2308

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%.

2309

GINGER POWDER

A,E,H

2310

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.

2311

GLACIAL ACETIC ACID

E,H

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

2312

GLECHOMA HEDERACEA

A,H

2313

GLECHOMA LONGITUBA

A,H

2314

GLEDITSIA AUSTRALIS

A,H

2315

GLEDITSIA SINENSIS

A,H

2316

GLEHNIA LITTORALIS

A,H

2317

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%.

2318

GLUCOMANNAN

E

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

2319

GLUCONOLACTONE

E

2320

GLUCOSAMINE HYDROCHLORIDE

A,E

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

- (SFOOD) 'Derived from seafood'.

2321

GLUCOSAMINE SULFATE

A

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

- (SFOOD) 'Derived from seafood'.

2322

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.’

2323

GLUCOSAMINE SULFATE SODIUM CHLORIDE

A

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

- (SFOOD) 'Derived from seafood'.

2324

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).

2325

GLUCOSE GLUTAMATE

E

Only for use in topical medicines for dermal application.

2326

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).

2327

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%.

2328

GLUTAMIC ACID

A,E

Only for use in topical medicines for dermal application.

2329

GLUTAMIC ACID HYDROCHLORIDE

A,E,H

2330

GLUTAMINE

A,E,H

2331

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%.

2332

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).

2333

GLUTEN-FREE WHEAT STARCH

E

2334

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%.

2335

GLYCEROL

A,E

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

2336

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.

2337

GLYCERYL BEHENATE

E

Behenic acid is a mandatory component of calcium 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%.

2338

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%.

2339

GLYCERYL DIISOSTEARATE

E

For use in topical medicines for dermal application.

2340

GLYCERYL DILAURATE

E

Only for use in topical medicines for dermal application.

2341

GLYCERYL DIOLEATE

E

Only for use in topical medicines for dermal application.

2342

GLYCERYL DISTEARATE

E

Only for use in topical medicines for dermal application.

2343

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%.

2344

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%.

2345

GLYCERYL LAURATE

E

Only for use in topical medicines for dermal application.

2346

GLYCERYL LINOLEATE

E

Only for use in topical medicines for dermal application.

2347

GLYCERYL LINOLENATE

E

Only for use in topical medicines for dermal application.

2348

GLYCERYL MONOOLEATE

E

2349

GLYCERYL MONOSTEARATE

E

2350

GLYCERYL MYRISTATE

E

Only for use in topical medicines for dermal application.

2351

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.

2352

GLYCERYL PALMITO-STEARATE

E

2353

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%.

2354

GLYCERYL POLYMETHACRYLATE

E

Only for use in topical medicines for dermal application.

2355

GLYCERYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

2356

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.

2357

GLYCERYL SORBITAN OLEOSTEARATE

E

Only for use in topical medicines for dermal application.

2358

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.

2359

GLYCERYL STEARATE CITRATE

E

Only for use in topical medicines for dermal application.

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

2360

GLYCERYL TRIACETYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

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

2361

GLYCERYL TRIACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

2362

GLYCERYL TRINITRATE

H

Only for use as an active homoeopathic ingredient.

2363

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%.

2364

GLYCINE

A,E

2365

GLYCINE MAX

A,E,H

2366

GLYCOGEN

E

Only for use in topical medicines for dermal application.

2367

GLYCOL DISTEARATE

E

Only for use in topical medicines for dermal application.

2368

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.

2369

GLYCYRRHIZA GLABRA

A,E,H

2370

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%.

2371

GLYCYRRHIZA URALENSIS

A,E,H

2372

GLYCYRRHIZINIC ACID

E

2373

GNAPHALIUM AFFINE

A,H

2374

GNAPHALIUM POLYCEPHALUM

A,H

2375

GNAPHALIUM ULIGINOSUM

A,H

2376

GOAT

H

Only for use as an active homoeopathic ingredient.

2377

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).

2378

GOLD

E,H

Only for use as an active homoeopathic or excipient ingredient.

2379

GOLD CHLORIDE

H

Only for use as an active homoeopathic ingredient.

2380

GOLDEN ROD HERB DRY

A,E,H

2381

GOLDEN SEAL ROOT DRY

A,H

2382

GOLDEN SEAL ROOT POWDER

A,H

2383

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).

2384

GOMPHRENA GLOBOSA

A,H

2385

GOOSEBERRY

E

2386

GOSSYPIUM HERBACEUM

A,E,H

2387

GRAPE

E

2388

GRAPE SEED OIL

E

2389

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’

2390

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’

2391

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’

2392

GRAPEFRUIT

E

2393

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%.

2394

GRAPEFRUIT OIL COLDPRESSED

A,E,H

2395

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%.

2396

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%.

2397

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%.

2398

GRAPHITE

H

Only for use as an active homoeopathic ingredient.

2399

GRATIOLA LINIFOLIA

A,H

2400

GREATER NETTLE HERB DRY

A,H

2401

GREATER NETTLE HERB POWDER

A,H

2402

GREATER NETTLE ROOT DRY

A,H

2403

GREATER NETTLE ROOT POWDER

A,H

2404

GREEN LIPPED MUSSEL

A

2405

GREEN LIPPED MUSSEL DRIED

A

2406

GREEN LIPPED MUSSEL OIL

A

2407

GREEN S

E

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

2408

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.'

2409

GRINDELIA CAMPORUM

A,H

2410

GRINDELIA ROBUSTA

A,H

2411

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%.

2412

GROUND IVY HERB DRY

A,H

2413

GROUND IVY HERB POWDER

A,H

2414

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%.

2415

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%.

2416

GUAIACUM OFFICINALE

A,E,H

2417

GUAIACUM RESIN

A,E,H

2418

GUAIACUM SANCTUM

A,H

2419

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%.

2420

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%.

2421

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%.

2422

GUANINE

E

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

2423

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.

2424

GUAR GUM

A,E,H

2425

GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE

E

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

2426

GUAREA RUSBYI

A,H

2427

GUAVA

E

2428

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%.

2429

GYMNEMA SYLVESTRE

A,H

2430

GYMNOCLADUS DIOICA

A,H

2431

GYNOSTEMMA PENTAPHYLLUM

A

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

2432

GYNURA JAPONICA

A,H

2433

HAHNEMANN'S SOLUBLE MERCURY

H

Only for use as an active homoeopathic ingredient.

2434

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.

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

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

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

- (VITA2) 'WARNING: If you are pregnant - or considering becoming pregnant - do not take vitamin A supplements without consulting your 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 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' is permitted only for oral use.

2435

HAMAMELIS LEAF DRY

A,H

2436

HAMAMELIS LEAF POWDER

A,H

2437

HAMAMELIS VIRGINIANA

A,E,H

2438

HAMAMELIS WATER

A,E,H

2439

HANDROANTHUS HEPTAPHYLLUS

A,H

2440

HANDROANTHUS IMPETIGINOSUS

A,E,H

2441

HARD FAT

E

2442

HARD PARAFFIN

E

2443

HARICOT BEAN

E

2444

HARPAGOPHYTUM PROCUMBENS

A,E,H

2445

HARUNGANA MADAGASCARIENSIS

A,H

2446

HAZEL NUT

E

2447

HAZEL NUT OIL

E

2448

HEAVY KAOLIN

E

2449

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.

2450

HECTORITE

E

Only for use in topical medicines for dermal application.

2451

HEDEOMA PULEGIOIDES

A

2452

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%.

2453

HEDTA

E

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

2454

HEKLA LAVA

H

Only for use as an active homoeopathic ingredient.

2455

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%.

2456

HELIANTHEMUM NUMMULARIUM

A,H

2457

HELIANTHUS ANNUUS

A,E,H

2458

HELIANTHUS TUBEROSUS

A,H

2459

HELICHRYSUM ANGUSTIFOLIUM

A,E,H

2460

HELICHRYSUM ARENARIUM

A,H

2461

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%.

2462

HELLEBORUS NIGER

A,H

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

2463

HELLEBORUS VIRIDIS

A,H

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

2464

HELONIAS RHIZOME DRY

A,H

2465

HELONIAS RHIZOME POWDER

A,H

2466

HEMIDESMUS INDICUS

A,E,H

2467

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%.

2468

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%.

2469

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%.

2470

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%.

2471

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%.

2472

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%.

2473

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%.

2474

HERACLEUM HEMSLEYANUM

A,H

2475

HERNIARIA GLABRA

A,H

2476

HESPERIDIN

A,E

2477

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%.

2478

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%.

2479

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%.

2480

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%.

2481

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.

2482

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%.

2483

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%.

2484

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 %.

2485

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%.

2486

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%.

2487

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%.

2488

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%.

2489

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%.

2490

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%.

2491

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%.

2492

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%.

2493

HEXYL LAURATE

E

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

2494

HEXYL NICOTINATE

E

2495

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%.

2496

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%.

2497

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%.

2498

HEXYLENE GLYCOL

E

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

2499

HIBISCUS ESCULENTUS

A,H

2500

HIBISCUS MUTABILIS

A,H

2501

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%.

2502

HIBISCUS SABDARIFFA

A,E,H

2503

HIERACIUM PILOSELLA

A,H

2504

HIGH AMYLOSE MAIZE STARCH

A,E,H

2505

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.

2506

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%.

2507

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.

2508

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 mcg 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.

2509

HIMATANTHUS LANCIFOLIUS

A,E,H

2510

HIPPOPHAE RHAMNOIDES

A,E,H

2511

HIRSCHFELDIA INCANA

A,H

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

When the herbal substance is derived from the seed, the maximum recommended daily dose must be no more than 20mg of allyl isothiocyanate.

2512

HISTAMINE DIHYDROCHLORIDE

H

Only for use as an active homoeopathic ingredient. 

2513

HISTIDINE

A

2514

HISTIDINE HYDROCHLORIDE

A,E,H

2515

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%.

2516

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%.

2517

HOLCUS LANATUS

A,H

2518

HOLY THISTLE HERB DRY

A,H

2519

HOLY THISTLE HERB POWDER

A,H

2520

HOMALOMENA OCCULTA

A,H

2521

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%.

2522

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).

2523

HONEY BEE

H

Only for use as an active homoeopathic ingredient.

2524

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%.

2525

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%.

2526

HOP STROBILE DRY

A,H

2527

HOP STROBILE POWDER

A,H

2528

HOPS OIL

A,E,H

2529

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.

2530

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.

2531

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%.

2532

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).

2533

HOTTONIA PALUSTRIS

A,H

2534

HOUTTUYNIA CORDATA

A,H

2535

HOVENIA DULCIS

A,H

2536

HUMULUS LUPULUS

A,E,H

2537

HYALURONIC ACID

E

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

2538

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.

2539

HYDRANGEA ARBORESCENS

A,H

2540

HYDRANGEA PANICULATA

A,H

2541

HYDRASTIS CANADENSIS

A,E,H

2542

HYDRATED SILICA

E

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

2543

HYDROCHLORIC ACID

E,H

Only for use as an active homoeopathic ingredient. 

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

2544

HYDROCOTYLE UMBELLATA

A,H

2545

HYDROFLUORIC ACID

H

Only for use as an active homoeopathic ingredient. 

2546

HYDROGEN CYANIDE

H

Only for use as an active homoeopathic ingredient. 

2547

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.

2548

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%.

2549

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%.

2550

HYDROGENATED CASTOR OIL

E

2551

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%.

2552

HYDROGENATED COCONUT OIL

E

2553

HYDROGENATED COTTONSEED OIL

E

2554

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.

2555

HYDROGENATED ETHYLENE/PROPYLENE/STYRENE COPOLYMER

E

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

2556

HYDROGENATED LANOLIN

E

2557

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%.

2558

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%.

2559

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%.

2560

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.

2561

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.

2562

HYDROGENATED POLYISOBUTENE

E

Only for use in topical medicines for dermal application.

2563

HYDROGENATED SOYA OIL

E

2564

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%.

2565

HYDROGENATED VEGETABLE OIL

E

2566

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%.

2567

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%

2568

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%

2569

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%.

2570

HYDROLYSED COLLAGEN

E

2571

HYDROLYSED ELASTIN

E

Only for use in topical medicines for dermal application.

2572

HYDROLYSED GELATIN

A,E

2573

HYDROLYSED GLYCOSAMINOGLYCANS

E

Only for use in topical medicines for dermal application.

2574

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%.

2575

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%.

2576

HYDROLYSED MAIZE STARCH

E

2577

HYDROLYSED MILK PROTEIN

E

2578

HYDROLYSED RICE

A,E,H

2579

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%.

2580

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%.

2581

HYDROLYSED VEGETABLE PROTEIN

E

2582

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.

2583

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%.

2584

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%.

2585

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%.

2586

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.

2587

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.’

2588

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%.

2589

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.'

2590

HYDROXYCITRATE COMPLEX

A

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

2591

HYDROXYCITRIC ACID

A

2592

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%.

2593

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%.

2594

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%.

2595

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%.

2596

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%.

2597

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%.

2598

HYDROXYLATED LANOLIN

E

2599

HYDROXYLATED MILK 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 must be no more than 0.1%.

2600

HYDROXYLYSINE

A,E

2601

HYDROXYMETHYLCELLULOSE

E

2602

HYDROXYOCTACOSANYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

2603

HYDROXYPALMITOYL SPHINGANINE

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 must be no more than 0.1%.

2604

HYDROXYPROLINE

A,E

2605

HYDROXYPROPYL DISTARCH PHOSPHATE

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 4%.

2606

HYDROXYPROPYL STARCH

E

2607

HYDROXYPROPYLBETADEX

E

Only for use in topical medicines for dermal application.

2608

HYDROXYSTEARIC ACID

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 9%.

2609

HYETELLOSE

E

2610

HYLOCEREUS UNDATUS

A,H

2611

HYMETELLOSE

E

2612

HYOSCAMUS LEAF DRY

A,H

Alkaloids calculated as hyoscyamine and hyoscine are mandatory components of Hyoscyamus leaf dry.

The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. 

The concentration of hyoscine in the medicine must be no more than than 300 micrograms/kg or 300 micrograms/L or 0.00003%.

2613

HYOSCAMUS LEAF POWDER

A,H

Alkaloids calculated as hyoscyamine and hyoscine are mandatory components of Hyoscamus leaf powder.

The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. 

The concentration of hyoscine in the medicine must be no more than than 300 micrograms/kg or 300 micrograms/L or 0.00003%.

2614

HYOSCYAMUS NIGER

A,H

Alkaloids calculated as hyoscyamine and hyoscine are mandatory components of Hyoscyamus niger.

The concentration of hyoscyamine in the medicine must be no more than 3 micrograms/kg or 3 micrograms/L or 0.3%.

The concentration of hyoscine in the medicine must be no more than than 300 micrograms/kg or 300 micrograms/L or 0.00003%.

2615

HYPERICUM ASCYRON

A,H

2616

HYPERICUM JAPONICUM

A,H

2617

HYPERICUM PERFORATUM

A,E,H

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

- (STJOHN) 'St John's Wort affects the way many prescription medicines work - including oral contraceptives. Consult your doctor.'

2618

HYPROLOSE

E

2619

HYPROMELLOSE

E

2620

HYPROMELLOSE PHTHALATE

E

2621

HYPTIS SUAVEOLENS

A,H

2622

HYSSOPUS OFFICINALIS

A,E,H

2623

IBERIS AMARA

A,H

2624

ICHTHAMMOL

H

Only for use as an active homoeopathic ingredient. 

2625

ILEX AQUIFOLIUM

A,H

2626

ILEX CHINENSIS

A,H

2627

ILEX PARAGUARIENSIS

A,E,H

Caffeine is a mandatory component of Ilex paraguariensis.

When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of more than 1 mg but no more than 10 mg of caffeine in the medicine requires the following warning statement on the medicine label:

- (CAFFR) ‘The recommended dose of this medicine provides small amounts of caffeine.’

When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of more than 10 mg of caffeine in the medicine requires the following warning statement on the medicine label:

- (CAFF) ‘Contains caffeine [state quantity per dosage unit or per mL or per gram of product]’.

2628

ILEX ROTUNDA

A,H

2629

ILEX VERTICILLATA

A,H

2630

ILLICIUM VERUM

A,H

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

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

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

2631

IMIDUREA

E

Only for use in topical medicines for dermal application.

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

- (IMIDUR) 'Contains imidurea [or words to that effect]'.

2632

IMMORTELLE

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%.

2633

IMMORTELLE 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%.

2634

IMPATIENS

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%.

2635

IMPATIENS BALSAMINA

A,H