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

Note: See sections 5 and 6.

Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient Name

Purpose

Specific requirements

3648

P-ALPHA-DIMETHYL STYRENE

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%.

 

3649

P-ANISIC ACID

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 0.3%.

 

3650

PADIMATE O

A

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

The concentration in the medicine must not be more than 8%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

3651

PADINA PAVONICA THALLUS PHYTOSTEROLS

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 0.01%.

 

3652

PAEONIA LACTIFLORA

A, E, H

 

3653

PAEONIA OBOVATA

A, H

 

3654

PAEONIA SUFFRUTICOSA

A, E, H

 

3655

PAEONIA VEITCHII

A, H

 

3656

PALIURUS SPINA-CHRISTI

A, H

 

3657

PALLADIUM

H

Only for use as an active homoeopathic ingredient.

 

3658

PALM FRUIT OIL

A, E, H

 

3659

PALM GLYCERIDES

E

 

3660

PALM KERNEL OIL

A, E, H

 

3661

PALM TOCOTRIENOLS COMPLEX

A, H

 

3662

PALMARIA PALMATA

A, H

 

3663

PALMAROSA OIL

A, E, H

 

3664

PALMIDROL

A

Only permitted for use in medicines limited to oral routes of administration.

The maximum recommended daily dose of the medicine must not provide more than 600 mg of palmidrol.

The following warning statements (or words to the same effect) are required on the medicine label:

- (ANALG) 'The medicine may interact with other prescription analgesic medicines, please consult your healthcare practitioner before use.'

- (ADULT) ‘Adults only.’

- (21DAYS) ‘Not to be used for more than 21 consecutive days.’

 

3665

PALMITIC ACID

E

 

3666

PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS

A

 

3667

PALMITOYL DIPEPTIDE-7

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 0.002%.

 

3668

PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER

E

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

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

 

3669

PALMITOYL OLIGOPEPTIDE

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 0.002%.

 

3670

PALMITOYL PENTAPEPTIDE-3

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 0.0005%.

 

3671

PALMITOYL TETRAPEPTIDE-3

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 0.001%.

 

3672

PANAX GINSENG

A, E, H

 

3673

PANAX JAPONICUS

A, H

 

3674

PANAX NOTOGINSENG

A, H

 

3675

PANAX PSEUDOGINSENG

A, H

 

3676

PANAX QUINQUEFOLIUS

A, H

 

3677

PANICUM MILIACEUM

A, H

 

3678

PANTETHINE

E

Only for use in topical medicines for dermal application.

 

3679

PANTHENOL

A, E

 

3680

PANTHENYL ETHYL ETHER

E

Only for use in topical medicines for dermal application.

 

3681

PANTOLACTONE

E

 

3682

PANTOTHENIC ACID

A, E

When used topically, the concentration in the medicine must be no more than 0.1%.

 

3683

PANTOTHENIC ACID POLYPEPTIDE

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%.

 

3684

PAPAIN

A, E

 

3685

PAPER

E

Only for use in topical medicines for dermal application.

 

3686

PAPRIKA OLEORESIN

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%.

 

3687

PARA-CRESOL

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%.

 

3688

PARA-CRESYL 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%.

 

3689

PARA-CRESYL 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%.

 

3690

PARA-CRESYL PHENYLACETATE

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%.

 

3691

PARA-CYMENE

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%.

 

3692

PARA-ETHOXYBENZALDEHYDE

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%.

 

3693

PARA-ETHYL CRESOXYACETATE

E

Para-ethyl cresoxyacetate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing para-ethyl cresoxyacetate must not be more than 1% of the total medicine.

 

3694

PARA-ETHYLPHENOL

E

Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

The maximum recommended daily dose must contain no more than 0.12 mg of para-ethylphenol.

The total flavour proprietary excipient formulation in a medicine must be no more than 5%.

 

3695

PARA-HYDROXY BENZALACETONE

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%.

 

3696

PARA-HYDROXYBENZOIC ACID

E

 

3697

PARA-MENTHA-8-THIOL-3-ONE

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%.

 

3698

PARA-METHYL ACETOPHENONE

E

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

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

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

 

3699

PARA-METHYL ANISOLE

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%.

 

3700

PARA-METHYL DIMETHYLBENZYL CARBINOL

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%.

 

3701

PARA-PROPYL ANISOLE

E

Para-propyl anisole must only be included in medicines when in combination with other permitted ingredients as a fragrance and/or flavour proprietary excipient formulation.

 The total concentration of fragrance proprietary excipient formulations containing para-propyl anisole must not be more than 1% of the total medicine.

The total concentration of flavour proprietary excipient formulations containing para-propyl anisole must not be more than 5% of the total medicine.

 

3702

PARA-TERT-BUTYLCYCLOHEXYL 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%.

 

3703

PARA-TERT-BUTYLPHENYL-ALPHA-METHYLHYDROCINNAMIC ALDEHYDE

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%.

 

3704

PARA-TOLUALDEHYDE

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%.

 

3705

PARA-TOLYL ACETALDEHYDE

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%.

 

3706

PARAMERIA LAEVIGATA

A, H

 

3707

PARIETARIA JUDAICA

A, H

 

3708

PARIS POLYPHYLLA

A, H

 

3709

PARIS QUADRIFOLIA

A, H

 

3710

PARSLEY

E, H

 

3711

PARSLEY HERB DRY

A, E, H

 

3712

PARSLEY HERB OIL

A, E, H

 

3713

PARSLEY HERB POWDER

A, E, H

 

3714

PARSLEY SEED OIL

A, E, H

 

3715

PARTHENOCISSUS TRICUSPIDATA

A, H

 

3716

PARTIALLY DEHYDRATED LIQUID SORBITOL

E

Sorbitol is a mandatory component of partially dehydrated liquid sorbitol.

Permitted for use only as part of the capsule in medicines where the dosage form is a soft capsule.

 

3717

PARTIALLY HYDROGENATED SOYA 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 the medicine must be no more than 5%.

 

3718

PARTIALLY REFINED PORPHYRA YEZOENSIS CYTOPLASM 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 in the medicine must be no more than 0.00002%.

 

3719

PASPALUM NOTATUM

A, H

 

3720

PASSIFLORA CAERULEA

A, H

 

3721

PASSIFLORA EDULIS

E

 

3722

PASSIFLORA HERB DRY

A, H

 

3723

PASSIFLORA INCARNATA

A, E, H

 

3724

PATCHOULI 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%.

 

3725

PATENT BLUE V

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

3726

PATENT BLUE V ALUMINIUM LAKE

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

3727

PATRINIA SCABIOSIFOLIA

A, H

 

3728

PATRINIA VILLOSA

A, H

 

3729

PAULLINIA CUPANA

A, E, H

Caffeine is a mandatory component of Paullinia cupana.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

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

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

3730

PAULLINIA PINNATA

A, H

 

3731

PAWPAW

E

 

3732

PEA

E

 

3733

PEA STARCH

E

 

3734

PEACH

E

 

3735

PEANUT

E

 

3736

PEAR

E

 

3737

PECAN

E

 

3738

PECTIN

A, E

 

3739

PEG-10 DIMETICONE

E

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

The concentration in the medicine must be no more than 4.0%.

 

3740

PEG-10 SOYA STEROL

E

Only for use in topical medicines for dermal application.

 

3741

PEG-100 STEARATE

E

Only for use in topical medicines for dermal application.

 

3742

PEG-12 DILAURATE

E

 

3743

PEG-12 DIMETICONE/PPG-20 CROSSPOLYMER

E

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

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

 

3744

PEG-120 METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

 

3745

PEG-120 STEARATE

E

Only for use in topical medicines for dermal application.

 

3746

PEG-15 COCAMINE

E

Only for use in topical medicines for dermal application.

 

3747

PEG-150 DISTEARATE

E

Only for use in topical medicines for dermal application.

 

3748

PEG-20 ALMOND 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 0.5%.

 

3749

PEG-20 METHYL GLUCOSE DISTEARATE

E

Only for use in topical medicines for dermal application.

 

3750

PEG-20 METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

 

3751

PEG-20 SORBITAN ISOSTEARATE

E

Only for use in topical medicines for dermal application.

 

3752

PEG-20 STEARATE

E

Only for use in topical medicines for dermal application.

 

3753

PEG-25 PABA

A

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

The concentration in the medicine must not be more than 10%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

3754

PEG-30 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

 

3755

PEG-30 STEARATE

E

Only for use in topical medicines for dermal application.

 

3756

PEG-35 CASTOR OIL

E

 

3757

PEG-4 DILAURATE

E

Only for use in topical medicines for dermal application.

 

3758

PEG-4 LAURATE

E

Only for use in topical medicines for dermal application.

Dioxane and Ethylene oxide are mandatory components of PEG-4 laurate.

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

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

 

3759

PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

 

3760

PEG-40 CASTOR OIL

E

 

3761

PEG-40 HYDROGENATED CASTOR OIL

E

 

3762

PEG-40 SORBITAN DIISOSTEARATE

E

Only for use in topical medicines for dermal application.

Dioxane and Ethylene oxide are mandatory components of PEG-40 sorbitan diisostearate.

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

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

 

3763

PEG-40 STEARATE

E

Only for use in topical medicines for dermal application.

 

3764

PEG-45/DODECYL GLYCOL COPOLYMER

E

Only for use in topical medicines for dermal application.

 

3765

PEG-5 GLYCERYL STEARATE

E

Only for use in topical medicines for dermal application.

 

3766

PEG-50 STEARATE

E

Only for use in topical medicines for dermal application.

 

3767

PEG-55 PROPYLENE GLYCOL OLEATE

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 0.6%.

 

3768

PEG-6 LAURAMIDE

E

Only for use in topical medicines for dermal application.

 

3769

PEG-60 ALMOND 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 when used in medicines applied directly to the skin must be no more than 10%.

The concentration when used in bath oil medicines must be no more than 30%.

 

3770

PEG-60 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 2%.

 

3771

PEG-60 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

 

3772

PEG-7 COCAMIDE

E

Only for use in topical medicines for dermal application.

 

3773

PEG-7 GLYCERYL COCOATE

E

Only for use in topical medicines for dermal application.

 

3774

PEG-7 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

 

3775

PEG-75 LANOLIN

E

Only for use in topical medicines for dermal application.

 

3776

PEG-75 STEARATE

E

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

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

 

3777

PEG-8 CETYL DIMETHICONE

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 0.0005%.

 

3778

PEG-8 DILAURATE

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%.

 

3779

PEG-8 DISTEARATE

E

Only for use in topical medicines for dermal application.

 

3780

PEG-8 LAURATE

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%.

The levels of possible impurities such as ethylene oxide (and related material) must be kept below the level of detection.

 

3781

PEG-8 PROPYLENE GLYCOL COCOATE

E

 

3782

PEG-8 STEARATE

E

Only for use in topical medicines for dermal application.

 

3783

PEG-9 POLYDIMETHYLSILOXYETHYL DIMETICONE

E

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

The concentration in the medicine must be no more than 3.5%.

 

3784

PEG/PPG-14/7 DIMETHYL ETHER

E

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

The concentration in the medicine must be no more than 7%.

 

3785

PEG/PPG-18/18 DIMETHICONE

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%.

 

3786

PELARGONIUM GRAVEOLENS

A, E, H

 

3787

PELLITORINE

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%.

 

3788

PELTIGERA CANINA

A, H

 

3789

PENICILLIUM EXPANSUM

A, H

 

3790

PENNYROYAL OIL

E

D-Pulegone/Pulegone is a mandatory component of Pennyroyal Oil.

The concentration of D Pulegone/ Pulegone in the medicine must be no more than 4%.

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 the medicine must be no more than 5%.

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

When the medicine is for a use other than topical, the maximum recommended daily dose must be no more than 50 mg of Pennyroyal Oil.

 

3791

PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE

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 0.018%

 

3792

PENTAERYTHRITYL TETRAISOSTEARATE

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 61%.

 

3793

PENTAERYTHRITYL TETRALAURATE

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 80%.

 

3794

PENTAMETHYLHEPTENONE

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%.

 

3795

PENTANE

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%.

 

3796

PENTASODIUM ETHYLENEDIAMINE TETRAMETHYLENE PHOSPHONATE

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%.

 

3797

PENTYLENE GLYCOL

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%.

 

3798

PEPPER BLACK

E, H

 

3799

PEPPER 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%.

 

3800

PEPPER WHITE

E, H

 

3801

PEPPERMINT AMERICAN EXT.

E

Menthol is a mandatory component of peppermint american ext.

When the medicine is for topical use for dermal application:

a) the medicine must not be intended for use in the eye or on damaged skin;

b) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

c) the following warning statement is required on the medicine label:

- (EYE) Avoid contact with eyes (or words to that effect).

d) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

e) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

 

3802

PEPPERMINT LEAF DRY

A, E, H

Menthol is a mandatory component of peppermint leaf dry.

When the medicine is for topical use for dermal application:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(iii) the following warning statement is required on the medicine label:

- (EYE) Avoid contact with eyes (or words to that effect).

(iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

(v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

 

3803

PEPPERMINT LEAF POWDER

A, E, H

Menthol is a mandatory component of peppermint leaf powder.

When the medicine is for topical use for dermal application:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(iii) the following warning statement is required on the medicine label:

- (EYE) Avoid contact with eyes (or words to that effect).

(iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

(v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

 

3804

PEPPERMINT OIL

A, E, H

Menthol is a mandatory component of peppermint oil.

When the medicine is for topical use for dermal application:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(iii) the following warning statement is required on the medicine label:

- (EYE) Avoid contact with eyes (or words to that effect).

(iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

(v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

 

3805

PEPPERMINT OIL TERPENELESS

E

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

The total flavour proprietary excipient formulation in a medicine must be no more than 5%.

The total fragrance proprietary excipient formulation in a medicine must be no more 1%.

Menthol is a mandatory component of peppermint oil terpeneless.

When the medicine is for topical use for dermal application:

i) the medicine must not be intended for use in the eye or on damaged skin;

ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

iii) the following warning statement is required on the medicine label:

- (EYE) Avoid contact with eyes (or words to that effect).

iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

 

3806

PEPPERMINT OIL TERPENES AND TERPENOIDS

E

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

The total flavour proprietary excipient formulation in a medicine must be no more than 5%.

Menthol is a mandatory component of peppermint oil terpenes and terpenoids.

When the medicine is for topical use for dermal application:

i) the medicine must not be intended for use in the eye or on damaged skin;

ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

iii) the following warning statement is required on the medicine label:

- (EYE) Avoid contact with eyes (or words to that effect).

iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

 

3807

PERFLUOROPOLYMETHYLISOPROPYL ETHER

E

Only for use in topical medicines for dermal application.

 

3808

PERHYDRO-3,6-DIMETHYL-BENZO [B] FURAN-2-ONE

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%.

 

3809

PERILLA FRUTESCENS

A, E, H

 

3810

PERILLALDEHYDE

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%.

 

3811

PERLITE

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%.

 

3812

PERMETHRIN

E

The total concentration of permethrin in the medicine must not be more than 2%.

 

3813

PERSEA AMERICANA

A, E, H

 

3814

PERSIC OIL

A, E, H

Amygdalin and Hydrocyanic acid are mandatory components of Persic oil.

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

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

3815

PERSICARIA CHINENSIS

A, H

 

3816

PERSICARIA TINCTORIA

A, H

 

3817

PERSIMMON

E

 

3818

PERU BALSAM

A, E, H

 

3819

PERU BALSAM OIL

A, E, H

 

3820

PETITGRAIN MANDARIN OIL

E

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

The final concentration of the oil in the flavour does not exceed 30%

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

 

3821

PETITGRAIN 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%.

 

3822

PETITGRAIN OIL CITRONNIER

E

Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation.

When included in a medicine for use on the lips the concentration of petitgrain oil citronnier must be no more than 0.1%.

When included in dermal creams for infant use the concentration of petitgrain oil citronnier must be no more than 0.5%

The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

 

3823

PETITGRAIN OIL PARAGUAY

A, E, H

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

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

 

3824

PETITGRAIN OIL TERPENELESS

E

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

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

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

 

3825

PETROSELINUM CRISPUM

A, E, H

 

3826

PEUCEDANUM PRAERUPTORUM

A, E, H

 

3827

PEUMUS BOLDUS

A, H

Volatile oil components (of Peumus boldus) is a mandatory component.

The maximum recommended daily dose must be no more than 100 mg of volatile oil components (of Peumus boldus).

 

3828

PHALARIS ARUNDINACEA

A, H

 

3829

PHALARIS CANARIENSIS

A, H

 

3830

PHASEOLUS COCCINEUS

A, H

 

3831

PHASEOLUS VULGARIS

A, H

 

3832

PHELLINUS ROBINIAE

A, E, H

 

3833

PHELLODENDRON AMURENSE

A, E, H

 

3834

PHELLODENDRON CHINENSE

A, H

 

3835

PHENACETIN

E

Only for use in topical medicines for dermal application.

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

 

3836

PHENETHYL 2-METHYLBUTYRATE

E

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

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

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

 

3837

PHENETHYL 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%.

 

3838

PHENETHYL ALCOHOL

E

Permitted for use only:

a) in topical medicines for dermal application; and

b) for internal use in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

The total flavour proprietary excipient formulation concentration in a medicine must be no more than 5%.

 

3839

PHENETHYL BENZOATE

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 6%.

 

3840

PHENETHYL DIMETHICONE

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 0.2%

 

3841

PHENETHYL ISOAMYL ETHER

E

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

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

 

3842

PHENETHYL 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%.

 

3843

PHENETHYL 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%.

 

3844

PHENETHYL PHENYLACETATE

E

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

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

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

 

3845

PHENETHYL SALICYLATE

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%.

 

3846

PHENOL

E

Only for use in topical medicines for dermal application.

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

 

3847

PHENOXYACETALDEHYDE

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%.

 

3848

PHENOXYETHANOL

E

Only for use in topical medicines for dermal application.

The concentration of phenoxyethanol in the preparation must not exceed 15%.

 

3849

PHENOXYETHYL 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%.

 

3850

PHENOXYETHYLPARABEN

E

Only for use in topical medicines for dermal application.

 

3851

PHENYL DIMETHICONE

E

Only for use in topical medicines for dermal application.

 

3852

PHENYL TRIMETHICONE

E

Only for use in topical medicines for dermal application.

 

3853

PHENYLACETALDEHYDE

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%.

 

3854

PHENYLACETALDEHYDE 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%.

 

3855

PHENYLACETALDEHYDE GLYCERYLACETAL

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%.

 

3856

PHENYLACETIC 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%.

 

3857

PHENYLALANINE

A, E

When the maximum recommended daily dose of the medicine provides more than 500 mg phenylalanine, the following warning statement is required on the medicine label:

- (PREGNT2) 'Do not use if pregnant or likely to become pregnant'.

 

3858

PHENYLBENZIMIDAZOLE SULFONIC ACID

A

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

The concentration in the medicine must not be more than 4%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

3859

PHENYLETHYL 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%.

 

3860

PHENYLETHYL CAPROATE

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%.

 

3861

PHENYLETHYL CAPRYLATE

E

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

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

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

 

3862

PHENYLETHYL CINNAMATE

E

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

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

 

3863

PHENYLETHYL 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%.

 

3864

PHENYLETHYL METHYLETHYL CARBINOL

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%.

 

3865

PHENYLETHYL 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 than 1%.

 

3866

PHENYLETHYL 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%.

 

3867

PHENYLISOPROPYL DIMETICONE

E

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

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

 

3868

PHENYLPROPANOL

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 0.16%.

 

3869

PHLEUM PRATENSE

A, H

 

3870

PHLOXINE B

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

3871

PHLOXINE B ALUMINIUM LAKE

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

3872

PHOENIX DACTYLIFERA

A, E, H

 

3873

PHOSPHATIDYL CHOLINE

E

 

3874

PHOSPHOLIPIDS

E

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

The concentration in the medicine must be no more than 20%.

 

3875

PHOSPHORIC ACID

E, H

The concentration in liquid medicines must be no more than 15%.

 

3876

PHOSPHORUS

H

Only for use as an active homoeopathic ingredient.

The total concentration of phosphorus in the medicine must not be more than 1 mg/kg or 1 mg/L or 0.0001%.

 

3877

PHOTINIA SERRULATA

A, H

 

3878

PHRAGMITES AUSTRALIS

A, H

 

3879

PHYLLANTHUS AMARUS

A, H

 

3880

PHYLLANTHUS EMBLICA

A, E, H

When used as an excipient, only for use in topical medicines for dermal application.

 

3881

PHYLLOSTACHYS NIGRA

A, E, H

 

3882

PHYSALIS ALKEKENGI

A, H

 

3883

PHYSALIS PUBESCENS

A, H

 

3884

PHYTANTRIOL

E

Only for use in topical medicines for dermal application.

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

 

3885

PHYTOL

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%.

 

3886

PHYTOLACCA AMERICANA

A, H

The maximum recommended daily dose of the medicine must contain no more than 1mg of the equivalent dry herb.

 

3887

PHYTOMENADIONE

A, E

 

3888

PHYTOSPHINGOSINE

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%.

 

3889

PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE

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%.

 

3890

PICEA ABIES

A, H

 

3891

PICEA MARIANA

A, H

 

3892

PICRASMA EXCELSA

A, E, H

 

3893

PICRORRHIZA KURROA

A, E, H

 

3894

PIGMENT BLUE 15

E

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

The concentration in medicine must be no more than 0.003%.

 

3895

PIGMENT BLUE 15:1

E

Permitted for use only as a colour for topical use.

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 0.21%.

 

3896

PIGMENT GREEN 7

E

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

When for dental use, the concentration in the medicine must be no more than 0.003%.

When for topical use, the concentration in the medicine must be no more than 0.17%.

 

3897

PIGMENT RED 4

E

Permitted for use only as a colour for topical use.

 

3898

PIGMENT RED 53

E

Permitted for use only as a colour for topical use.

 

3899

PIGMENT RED 57

E

Permitted for use only as a colour for topical use.

 

3900

PIGMENT RED 57 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

 

3901

PIGMENT RED 57 BARIUM LAKE

E

Permitted for excipient use as a colour in topical medicines for dermal application.

Not to be included in medicines intended for use in the eye.

 

3902

PIGMENT RED 63

E

Permitted for use only as a colour for topical use.

 

3903

PIGMENT WHITE 26

E

Permitted for use only as a colour for topical use.

 

3904

PIGMENT YELLOW 12

E

Permitted for use only as a colour for topical use.

 

3905

PILOCARPUS JABORANDI

A, H

Pilocarpine is a mandatory component of Pilocarpus  jaborandi.

The concentration of pilocarpine in the medicine must be no more than 0.025%.

 

3906

PILOCARPUS MICROPHYLLUS

A, H

Pilocarpine is a mandatory component of Pilocarpus microphyllus.

The concentration of pilocarpine in the medicine must be no more than 0.025%.

 

3907

PILOCARPUS PINNATIFOLIUS

A, H

Pilocarpine is a mandatory component of Pilocarpus pinnatifolius.

The concentration of pilocarpine in the medicine must be no more than 0.025%.

 

3908

PIMENTA FRUIT OIL

A, E, H

 

3909

PIMENTA LEAF OIL

A, E, H

 

3910

PIMENTA OFFICINALIS

A, E, H

 

3911

PIMENTA RACEMOSA

A, E, H

When the plant preparation for Pimenta racemosa is an oil and the concentration of this oil in the medicine is more than 25%, the nominal capacity of the container must be no more than 25 mL.

When the plant preparation for Pimenta racemosa is an oil, the concentration of this oil in the medicine is more than 25%, and  the nominal capacity of the container is more than 15 mL, a restricted flow insert must be fitted on the container.

When the plant preparation for Pimenta racemosa is an oil, the concentration of this oil in the medicine is more than 25%, and the nominal capacity of the container is more than 15 mL but no more than 25 mL, a child resistant closure and restricted flow insert must be fitted on the container.

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

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

- (NTAKEN) 'Not to be taken'.

 

3912

PIMPINELLA ANISUM

A, E, H

When the plant preparation for Pimpinella anisum is an oil or distillate and the concentration of this oil or distillate in the medicine is more than 50%:

a) the nominal capacity of the container must be no more than 50 millilitres; and

b) a restricted flow insert is must be fitted on the container; and

c) the medicine requires the following warning statement on the medicine label:

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

 

3913

PIMPINELLA SAXIFRAGA

A, E, H

 

3914

PINE NEEDLE OIL SCOTCH

A, E, H

 

3915

PINE NEEDLE OIL TERPENELESS

E

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

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

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

 

3916

PINE OIL AROMATIC

A, E, H

 

3917

PINE OIL PUMILIO

A, E, H

 

3918

PINEAPPLE

E

 

3919

PINEAPPLE OILS

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%.

 

3920

PINELLIA TERNATA

A, H

 

3921

PINUS CONTORTA

A, E, H

 

3922

PINUS ELLIOTTII

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%.

 

3923

PINUS MASSONIANA

A, E, H

When the plant preparation is oil or distillate the total concentration of Pinus massoniana oil or distillate in the preparation must be no more than 25%.

 

3924

PINUS MONTICOLA

A, E, H

 

3925

PINUS MUGO

A, E, H

 

3926

PINUS PALUSTRIS

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%.

 

3927

PINUS PINASTER

A, E, H

When the plant preparation is oil or distillate the total concentration of Pinus pinaster oil or distillate in the preparation must be no more than 25%.

 

3928

PINUS PONDEROSA

A, E, H

 

3929

PINUS RADIATA

A, E, H

 

3930

PINUS STROBUS

A, E, H

 

3931

PINUS SYLVESTRIS

A, E, H

 

3932

PINUS TABULIFORMIS

A, E, H

 

3933

PINUS YUNNANENSIS

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%.

 

3934

PIPENZOLATE BROMIDE

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%.

 

3935

PIPER CHABA

A, E, H

 

3936

PIPER CUBEBA

A, E, H

 

3937

PIPER KADSURA

A, E, H

 

3938

PIPER LONGUM

A, E, H

 

3939

PIPER METHYSTICUM

A, H

Kavalactones (of Piper methysticum) is a mandatory component of Piper methysticum.

Only for oral use when the dosage form is 'tablet' or 'capsule'; or when the container type is 'tea bag'.

When used in oral medicines, the maximum daily dose of kavalactones (of Piper methysticum) must be no more than 250 mg.

If the dosage form is tablet or capsule then the quantity of kavalactones (of Piper methysticum) must be no more than 125 mg per tablet or capsule.

Oral medicines containing more than 25 mg of kavalactones (of Piper methysticum) per dose require the following warning statement on the medicine label:

- (PIPER) 'Not for prolonged use. If symptoms persist - seek advice from a healthcare practitioner. Not recommended for pregnant or lactating women (or words to that effect). May harm the liver'.

The plant part must be root or rhizome.

When for oral use, the medicine may only contain dried whole or peeled root or rhizome or aqueous dispersions or aqueous extracts of whole or peeled root or rhizome.

When for topical use on the rectum, vagina or throat, the medicine may only contain dried whole or peeled root or rhizome or aqueous dispersions or aqueous extracts of whole or peeled root or rhizome.

When the container type is tea bag the maximum quantity per tea bag must be no more than 3 grams of dried whole or peeled root or rhizomes.

 

3940

PIPER NIGRUM

A, E, H

 

3941

PIPER SARMENTOSUM

A, E, H

 

3942

PIPERINE

E

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

The total flavour proprietary formulation in a medicine must not be more than 5% and the concentration of piperine in the medicine must not be more than 0.15%.

 

3943

PIPERITONE

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%.

 

3944

PIPERONAL

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%.

 

3945

PIPERONYL ACETONE

E

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

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

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

 

3946

PIPERONYL BUTOXIDE

E

Only for use in topical medicines for dermal application.

 

3947

PIROCTONE OLAMINE

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% in wash-on/wash-off medicines and 0.5% in leave-on medicines.

 

3948

PISCIDIA PISCIPULA

A, E, H

 

3949

PISTACIA LENTISCUS

A, E, H

 

3950

PISUM SATIVUM

A, E, H

 

3951

PLACENTA

H

Only for use as an active homoeopathic ingredient.

 

3952

PLANTAGO AFRA

A, E, H

When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

 

3953

PLANTAGO ARENARIA

A, H

When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

 

3954

PLANTAGO ASIATICA

A, H

When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

 

3955

PLANTAGO LANCEOLATA

A, E, H

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

- (CHILD5) 'Use in children under 3 years is not recommended’

When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

 

3956

PLANTAGO MAJOR

A, E, H

When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

 

3957

PLANTAGO OVATA

A, H

When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

 

3958

PLANTAGO SEED DRY

A, H

When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

 

3959

PLATANUS OCCIDENTALIS

A, E, H

 

3960

PLATANUS RACEMOSA

A, H

 

3961

PLATANUS × HISPANICA

A, H

 

3962

PLATYCODON GRANDIFLORUS

A, E, H

 

3963

PLECTRANTHUS BARBATUS

A, E, H

 

3964

PLICATONE

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%.

 

3965

PLUM

E

 

3966

PLUMBAGO EUROPAEA

A, H

 

3967

PLUMERIA ALBA

A, E, H

 

3968

PLUMERIA RUBRA

A, E, H

 

3969

POA NEMORALIS

A, H

 

3970

POA PRATENSIS

A, H

 

3971

PODOPHYLLUM PELTATUM

A, H

Podophyllin and podophyllotoxin are mandatory components of Podophyllum peltatum.

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

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

 

3972

POGOSTEMON CABLIN

A, E, H

 

3973

POLACRILIN

E

 

3974

POLACRILIN POTASSIUM

E

 

3975

POLAPREZINC

A

Only for use in oral medicines.

Zinc is a mandatory component of Polaprezinc.

The maximum recommended daily dose must be no more than 34 milligrams of zinc sourced from polaprezinc.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period' (or words to that effect).

 

3976

POLIGLUSAM

A, E

The average molecular mass of poliglusam must be greater than 2 kilodaltons.

When for internal use:

(a) the maximum recommended daily dose of the medicine must not provide more than 1750 milligrams poliglusam; and

(b) the following warning statement is required on the medicine label:

- (CHITO) 'Poliglusam should be taken at least one hour after any other medication as it may reduce the effect of other medication' (or words to that effect).

When for internal use and the dosage form is a powdered preparation, the following warning statement is required on the medicine label:

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

When used as an excipient, only for use in topical medicines for dermal application.

 

3977

POLIGLUSAM DERIVED FROM ASPERGILLUS NIGER

A, E

When for oral use:

(a) the maximum recommended daily dose of the medicine must not provide more than 2000 mg of Poliglusam derived from Aspergillus niger;

(b) the following warning statement (or words to the same effect) is required on the medicine label:

- (CHITO) 'Poliglusam should be taken at least one hour after any other medication as it may reduce the effect of other medication.'; and

(c) if the medicine is a powdered dosage form, the following warning statement is also required on the medicine label:

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

When used as an excipient, Poliglusam derived from Aspergillus niger is only permitted for use in topical medicines for dermal application.

 

3978

POLLACK-LIVER OIL

A, E

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

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

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

When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label:

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

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

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

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

 

3979

POLLEN

E

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

- (POLLEN) 'This medicine can cause severe allergic reactions' (or words to that effect).

 

3980

POLOXAMER

E

Only for use in topical medicines for dermal application.

 

3981

POLOXAMINE

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%.

 

3982

POLOXAMINE 1301

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%.

 

3983

POLY C10-30 ALKYL ACRYLATE

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%.

 

3984

POLYACRYLAMIDE

E

Only for use in topical medicines for dermal application.

Acrylamide is a mandatory component of Polyacrylamide.

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

 

3985

POLYACRYLATE CROSSPOLYMER-6

E

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

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

 

3986

POLYACRYLATE-1 CROSSPOLYMER

E

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

The concentration in the medicine must be no more than 0.4%.

 

3987

POLYACRYLIC ACID

E

 

3988

POLYAMINO SUGAR CONDENSATE

E

Only for use in topical medicines for dermal application.

 

3989

POLYAMINOPROPYL BIGUANIDE

E

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

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

 

3990

POLYBUTADIENE

E

Only for use as part of an adhesive in topical medicines for dermal application.

 

3991

POLYBUTENE

E

Only for use in topical medicines for dermal application.

 

3992

POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER

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%.

 

3993

POLYCAPROLACTONE

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%.

 

3994

POLYDECENE

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 6%.

 

3995

POLYDEXTROSE

E

 

3996

POLYDIETHYLSILOXANE

E

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

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

 

3997

POLYDIMETHYL SILOXANE

E

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

If used in a printing ink the total printing ink concentration in a medicine must be no more than 0.1%

 

3998

POLYESTER-10

E

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

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

 

3999

POLYESTER-25

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 10%.

 

4000

POLYESTER-7

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%.

 

4001

POLYESTER-8

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 Polyester-8 must be no more than 5%.

 

4002

POLYETHYLENE

E

 

4003

POLYGALA CHINENSIS

A, H

 

4004

POLYGALA SENEGA

A, E, H

Except when used in a medicine containing only homoeopathic preparations, a child resistant closure and restricted flow insert must be fitted onto the container.

 

4005

POLYGALA SIBIRICA

A, E, H

Only for use when the plant part is root or root bark.

 

4006

POLYGALA TENUIFOLIA

A

Only for use when the plant part is root or root bark.

 

4007

POLYGLYCERYL-10 PENTASTEARATE

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 1.5%.

 

4008

POLYGLYCERYL-2 CAPRATE

E

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

The concentration in the medicine must not be more than 0.5%.

 

4009

POLYGLYCERYL-2 DIISOSTEARATE

E

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

The concentration in the medicine must be no more than 3.0%.

 

4010

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application. 

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

 

4011

POLYGLYCERYL-2 DISTEARATE

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 not be more than 3%.

 

4012

POLYGLYCERYL-2 TRIISOSTEARATE

E

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

When the concentration of polyglyceryl-2 triisostearate is greater than 3%, the medicine must not be intended for use on damaged skin.

The concentration in the medicine must not be more than 5%.

 

4013

POLYGLYCERYL-2-PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

 

4014

POLYGLYCERYL-3 BEESWAX

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 0.5%.

 

4015

POLYGLYCERYL-3 DIISOSTEARATE

E

Only for use in topical medicines for dermal application.

 

4016

POLYGLYCERYL-3 DISTEARATE

E

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

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

 

4017

POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE

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 6%.

 

4018

POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE

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%.

 

4019

POLYGLYCERYL-3 POLYRICINOLEATE

E

 

4020

POLYGLYCERYL-3 STEARATE/ISOSTEARATE/DIMER DILINOLEATE CROSSPOLYMER

E

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

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

 

4021

POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE

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%.

 

4022

POLYGLYCERYL-4 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%.

 

4023

POLYGLYCERYL-4 OLEATE

E

Only for use in topical medicines for dermal application.

 

4024

POLYGLYCERYL-6 POLYRICINOLEATE

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%.

 

4025

POLYGLYCERYL-6 RICINOLEATE

E

Only for use in topical medicines for dermal application.

 

4026

POLYGONATUM MULTIFLORUM

A, H

 

4027

POLYGONATUM OFFICINALE

A, H

 

4028

POLYGONATUM SIBIRICUM

A, E, H

 

4029

POLYGONUM AVICULARE

A, E, H

When used as an excipient, the medicine is only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin or in the eye.

When used as an excipient, the concentration in the medicine must be no more than 0.16%.

 

4030

POLYGONUM BISTORTA

A, H

 

4031

POLYGONUM ODORATUM

A, H

 

4032

POLYHYDROXYSTEARIC ACID

E

Only for use in topical medicines for dermal application.

 

4033

POLYISOBUTYLENE

E

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

Must comply with:

a) the Polyisobutylene 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.

 

4034

POLYISOPRENE

E

Only for use in topical medicines for dermal application.

 

4035

POLYLIMONENE

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%.

 

4036

POLYMETHACRYLIC ACID

E

 

4037

POLYMETHYL METHACRYLATE

E

Methyl methacrylate is a mandatory component of polymethyl methacrylate.

Only for use in topical medicines for dermal application.

The total concentration of methyl methacrylate as residual monomer in the medicine must not be more than 1%.

 

4038

POLYMETHYLSILSESQUIOXANE

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%.

 

4039

POLYPORUS UMBELLATUS

A, H

 

4040

POLYPROPYLENE

E

Only for use in topical medicines for dermal application.

 

4041

POLYPROPYLENE GLYCOL

E

Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation.

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

When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

 

4042

POLYQUATERNIUM-10

E

Only for use in topical medicines for dermal application.

 

4043

POLYQUATERNIUM-11

E

Only for use in topical medicines for dermal application.

 

4044

POLYQUATERNIUM-22

E

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

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

 

4045

POLYQUATERNIUM-24

E

Only for use in topical medicines for dermal application.

 

4046

POLYQUATERNIUM-28

E

Only for use in topical medicines for dermal application.

 

4047

POLYQUATERNIUM-37

E

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

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

 

4048

POLYQUATERNIUM-4

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 not be more than 0.4%.

 

4049

POLYQUATERNIUM-44

E

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

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

 

4050

POLYQUATERNIUM-51

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%.

 

4051

POLYQUATERNIUM-7

E

Only for use in topical medicines for dermal application.

 

4052

POLYSILICONE-11

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 2.1%

 

4053

POLYSILICONE-14

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 Polysilicone-14 must be no more than 1%.

 

4054

POLYSILICONE-15

A

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

The concentration in the medicine must not be more than 10%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

4055

POLYSILICONE-2

E

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

The concentration in the medicine must be no more than 0.13%.

 

4056

POLYSORBATE 20

E

 

4057

POLYSORBATE 40

E

 

4058

POLYSORBATE 60

E

 

4059

POLYSORBATE 65

E

 

4060

POLYSORBATE 80

E

 

4061

POLYSORBATE 85

E

Only for use in topical medicines for dermal application.

 

4062

POLYSTYRENE

E

Only for use as part of an adhesive in topical medicines for dermal application.

 

4063

POLYTEF

E

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

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

 

4064

POLYURETHANE-34

E

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

The concentration in the medicine must be no more than 2% in spray applications and 6% in non-spray applications.

 

4065

POLYURETHANE-62

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 5%.

 

4066

POLYVINYL ACETATE

E

Only permitted for use in medicines that are for oral routes of administration.

 

4067

POLYVINYL ACETATE PHTHALATE

E

 

4068

POLYVINYL ALCOHOL

E

 

4069

POLYVINYL CHLORIDE

E

Only for use in topical medicines for dermal application.

 

4070

POMEGRANATE

E

 

4071

PONCEAU SX

E

Permitted for use only as a colour for topical use.

 

4072

PONCIRUS TRIFOLIATA

A, H

When used internally, oxedrine is a mandatory component of Poncirus trifoliata.

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

 

4073

PONGAMOL

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%.

 

4074

PONTEDERIA CRASSIPES

A, H

 

4075

POPPY SEED

E, H

 

4076

POPPY SEED OIL

E, H

 

4077

POPULUS ALBA

A, H

 

4078

POPULUS BALSAMIIFERA

A, E, H

 

4079

POPULUS CANDICANS

A, H

 

4080

POPULUS DELTOIDES

A, H

 

4081

POPULUS NIGRA

A, H

 

4082

POPULUS TREMULA

A, H

 

4083

POPULUS TREMULOIDES

A, H

 

4084

PORCINE

H

Only for use as an active homoeopathic ingredient. 

 

4085

PORPHYRIDIUM PURPUREUM 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 in the medicine must be no more than 0.5%.

 

4086

PORTULACA OLERACEA

A, E, H

 

4087

POTABLE WATER

E

 

4088

POTASSIUM ACETATE

E

 

4089

POTASSIUM ARSENITE

H

Only for use as an active homoeopathic ingredient.

 

4090

POTASSIUM ASCORBATE

A, E, H

When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate.

 

4091

POTASSIUM ASCORBATE DIHYDRATE

A, E, H

When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate dihydrate.

 

4092

POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

4093

POTASSIUM ASPARTATE

A, E, H

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

 

4094

POTASSIUM ASPARTATE DIHYDRATE

A, E, H

If used as an active ingredient and the preparation is intended as a mineral supplementation, potassium is a mandatory component of Potassium aspartate dihydrate. The percentage of potassium from potassium aspartate dihydrate should be calculated based on the molecular weight of potassium aspartate dihydrate.

 

4095

POTASSIUM ASPARTATE MONOHYDRATE

A, E

If used as an active ingredient and the preparation is intended as a mineral supplementation, potassium is a mandatory component of Potassium aspartate monohydrate. The percentage of potassium from potassium aspartate monohydrate should be calculated based on the molecular weight of potassium aspartate monohydrate.

 

4096

POTASSIUM BICARBONATE

E

 

4097

POTASSIUM BROMIDE

H

Only for use as an active homoeopathic ingredient.

The total concentration of potassium bromide in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

 

4098

POTASSIUM CARBONATE

E, H

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

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

 

4099

POTASSIUM CETYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

4100

POTASSIUM CHLORIDE

A, E, H

When for oral use:

(a) potassium is a mandatory component of potassium chloride;

(b) the medicine requires the following warning statement on the medicine label:

- (POTAS1) '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.'; and

(c) except when the medicine is for use as oral rehydration therapy, the amount of potassium chloride per dosage unit must not be more than 550 mg.

Medicines containing potassium chloride for use as oral rehydration therapy, are subject to the following conditions:

(a) the medicine complies with the requirements specified in the British Pharmacopoeia, as in force or existing from time to time, for Oral Rehydration Salts;

(b) the sodium, potassium and glucose content, and total osmolarity of the solution after it has been prepared according to the instructions on the packet are consistent with the criteria specified by the World Health Organisation (WHO) and the United Nations Children's Fund (UNICEF) in the document 'Expert consultation on oral rehydration salts formulation' 18 July 2001; and

(c) the following warning statements are required on the medicine label:

- (UOAD) 'Use only as directed'

- (DIAR3) 'If diarrhoea persists, seek medical advice.'

When for dental use, the concentration of potassium chloride in the medicine must not be more than 3.75%.

 

4101

POTASSIUM CITRATE

A, E, H

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

 

4102

POTASSIUM COCOYL HYDROLYSED COLLAGEN

E

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

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

 

4103

POTASSIUM COCOYL HYDROLYSED SOY PROTEIN

E

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

The concentration in the medicine must be no more than 0.15%.

 

4104

POTASSIUM DICHROMATE

H

Only for use as an active homoeopathic ingredient.

 

4105

POTASSIUM GLUCONATE

A, E, H

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

 

4106

POTASSIUM GLYCEROPHOSPHATE

A, E, H

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

 

4107

POTASSIUM HYDROXIDE

E

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

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

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

 

4108

POTASSIUM HYDROXYCITRATE

A, H

 

4109

POTASSIUM IODATE

A, H

Iodine is a mandatory component of potassium iodate.

The percentage of iodine from potassium iodate should be calculated based on the molecular weight of potassium iodate.

When for use in adults, the medicine must contain a daily dose of no more than 505 micrograms of potassium iodate.

When for use in children aged 1-3 years, the medicine must contain a daily dose of no more than 337 micrograms of potassium iodate.

 

4110

POTASSIUM IODIDE

A, E, H

Iodine is a mandatory component of potassium iodide.

The percentage of iodine from potassium iodide should be calculated based on the molecular weight of potassium iodide.

When for internal use, the maximum recommended daily dose of the medicine must contains less than 300 micrograms of iodine.

When for external use, the concentration of iodine in the medicine (excluding salts derivatives or iodophors) must not exceed 2.5%.

 

4111

POTASSIUM METABISULFITE

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%.

 

4112

POTASSIUM METAPHOSPHATE

E

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

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

 

4113

POTASSIUM NITRATE

A, H

Only for dental use.

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

 

4114

POTASSIUM OROTATE

A, E, H

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

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

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

 

4115

POTASSIUM PYROPHOSPHATE

E

Only for oral application, dental or topical use.

Not to be included in topical medicines intended for use in the eye.

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

 

4116

POTASSIUM SORBATE

E

 

4117

POTASSIUM STANNATE

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%.

 

4118

POTASSIUM STEARATE

E

Only for use in topical medicines for dermal application.

 

4119

POTASSIUM SULFATE

A, E, H

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

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

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

 

4120

POTATO STARCH

E

 

4121

POTENTILLA ANSERINA

A, H

 

4122

POTENTILLA CHINENSIS

A, H

 

4123

POTENTILLA DISCOLOR

A, H

 

4124

POTENTILLA ERECTA

A, E, H

 

4125

POTENTILLA REPTANS

A, H

 

4126

POTERIUM OFFICINALE

A, E, H

 

4127

POTERIUM SANGUISORBA

A, H

 

4128

POVIDONE

E

 

4129

POWDERED CELLULOSE

E

 

4130

PPG-1-PEG-9 LAURYL GLYCOL ETHER

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%.

 

4131

PPG-12/SMDI COPOLYMER

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%.

 

4132

PPG-15 STEARYL ETHER

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%.

 

4133

PPG-15 STEARYL ETHER BENZOATE

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 1.4%.

 

4134

PPG-17/IPDI/DMPA 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 or on damaged skin.

The concentration of PPG-17/IPDI/DMPA Copolymer in the medicine must be no more than 10%.

 

4135

PPG-2 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

 

4136

PPG-2 MYRISTYL ETHER PROPIONATE

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%.

 

4137

PPG-20 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

 

4138

PPG-20 METHYL GLUCOSE ETHER

E

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

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

 

4139

PPG-20 METHYL GLUCOSE ETHER DISTEARATE

E

Only for use in topical medicines for dermal application.

 

4140

PPG-3 HYDROGENATED CASTOR OIL

E

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

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

 

4141

PPG-3 MYRISTYL ETHER

E

Only for use in topical medicines for dermal application.

 

4142

PPG-5-CETETH-20

E

Only for use in topical medicines for dermal application.

 

4143

PPG-5-LAUROMACROGOL 250

E

Only for use in topical medicines for dermal application.

 

4144

PRALINE

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%.

 

4145

PREGELATINISED MAIZE STARCH

E

 

4146

PREGELATINISED POTATO STARCH

E

 

4147

PREGELATINISED RICE STARCH

E

 

4148

PREGELATINISED STARCH

E

 

4149

PREGELATINISED WHEAT STARCH

E

When the route of administration is other than topical or mucosal, gluten is a mandatory component of pregelatinised wheat starch.

 

4150

PRENYL 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%.

 

4151

PRICKLY ASH BARK DRY

A, H

 

4152

PRICKLY ASH BARK POWDER

A, H

 

4153

PRIMULA VERIS

A, E, H

 

4154

PRIMULA VULGARIS

A, E, H

 

4155

PRINSEPIA UNIFLORA

A, H

 

4156

PROBOSCIDEA PARVIFLORA

A, H

 

4157

PROGESTERONE

H

Only for use as an active homoeopathic ingredient.

The total concentration of progesterone in the medicine must not be more than 1 mg/kg or 1 mg/L or 0.0001%.

 

4158

PROLINE

A, E

 

4159

PROPAN-1-OL

E

Only for use in:

- topical medicines for dermal application; or

- in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The concentration of propan-1-ol in the medicine must not be more than 18%.

When used in medicines in combination with other permitted ingredients as a flavour proprietary excipient formulation, the total flavour proprietary excipient formulation in a medicine must not be more than 5%.

 

4160

PROPANE

E

Only for use as an excipient propellant ingredient.

 

4161

PROPANEDIOL

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 10%.

 

4162

PROPENYL GUAETHOL

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%.

 

4163

PROPIONALDEHYDE

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%.

 

4164

PROPIONIC 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%.

 

4165

PROPIONYLLEVOCARNITINE HYDROCHLORIDE

A, H

 

4166

PROPOLIS

A, E

Lead is a mandatory component of Propolis.

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

When used topically, the medicine requires the following warning statement on the medicine label:

-(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

- (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'

 

4167

PROPOLIS BALSAM

A, E

Lead is a mandatory component of Propolis balsam.

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

When used topically, the medicine requires the following warning statement on the medicine label:

-(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

- (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'

 

4168

PROPOLIS DRY EXTRACT

A, E

Lead is a mandatory component of Propolis dry extract.

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

When used topically, the medicine requires the following warning statement on the medicine label:

-(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

- (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'

 

4169

PROPOLIS LIQUID EXTRACT

A, E

Lead is a mandatory component of Propolis liquid extract.

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

When used topically, the medicine requires the following warning statement on the medicine label:

-(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

- (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'

 

4170

PROPOLIS RESIN

A, E

Lead is a mandatory component of propolis resin.

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

When used topically, the medicine requires the following warning statement on the medicine label:

-(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

- (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'

 

4171

PROPOLIS TINCTURE

A, E

Lead is a mandatory component of Propolis tincture.

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

When used topically, the medicine requires the following warning statement on the medicine label:

-(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

- (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'

 

4172

PROPYL 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%.

 

4173

PROPYL CAPROATE

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%.

 

4174

PROPYL GALLATE

E

 

4175

PROPYL HYDROXYBENZOATE

E

 

4176

PROPYLENE CARBONATE

E

Only for use in topical medicines for dermal application.

 

4177

PROPYLENE GLYCOL

E

 

4178

PROPYLENE GLYCOL ALGINATE

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%.

 

4179

PROPYLENE GLYCOL DIBENZOATE

E

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

The concentration in the medicine must be no more than 20%.

 

4180

PROPYLENE GLYCOL DIDECANOATE

E

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

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

 

4181

PROPYLENE GLYCOL DIOCTANOATE

E

Only for use in topical medicines for dermal application.

 

4182

PROPYLENE GLYCOL DIOCTANOATE/DIDECANOATE

E

Only for use in topical medicines for dermal application.

 

4183

PROPYLENE GLYCOL DIPELARGONATE

E

Only for use in topical medicines for dermal application.

 

4184

PROPYLENE GLYCOL ISOCETETH-3 ACETATE

E

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

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

 

4185

PROPYLENE GLYCOL ISOSTEARATE

E

Only for use in topical medicines for dermal application.

 

4186

PROPYLENE GLYCOL MONOLAURATE

E

Only for use in topical medicines for dermal application.

 

4187

PROPYLENE GLYCOL MONOSTEARATE

E

Only for use in topical medicines for dermal application.

 

4188

PROPYLENE GLYCOL MYRISTYL ETHER ACETATE

E

Only for use in topical medicines for dermal application.

 

4189

PROSOPIS JULIFLORA

A, H

 

4190

PROTEASE

A

Must be derived from Aspergillus oryzae or Aspergillus niger.

 

4191

PROTEIN HYDROLYSATE

E

 

4192

PRUNE JUICE

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%.

 

4193

PRUNE JUICE 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%.

 

4194

PRUNELLA VULGARIS

A, H

 

4195

PRUNUS AFRICANA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus africana.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4196

PRUNUS ARMENIACA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus armeniaca and must be declared in the application.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4197

PRUNUS AVIUM

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus avium.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4198

PRUNUS CERASIFERA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus cerasifera.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4199

PRUNUS CERASUS

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus cerasus.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4200

PRUNUS DOMESTICA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus domestica.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4201

PRUNUS DULCIS

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus dulcis when the plant part is seed.

When the plant part is seed, the maximum recommended daily dose must be no more than the equivalent of 1mg of the dry seed.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4202

PRUNUS HUMILIS

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus humilis.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4203

PRUNUS JAPONICA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus japonica.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4204

PRUNUS LAUROCERASUS

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus laurocerasus.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4205

PRUNUS MUME

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus mume.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4206

PRUNUS PERSICA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus persica.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4207

PRUNUS SALICINA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus salicina.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4208

PRUNUS SEROTINA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus serotina.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4209

PRUNUS SPINOSA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus spinosa.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4210

PRUSSIAN BLUE

E

Permitted for use only as a colour for topical use.

 

4211

PSEUDOCYDONIA SINENSIS

A, H

 

4212

PSEUDOSTELLARIA HETEROPHYLLA

A, E, H

 

4213

PSEUDOTSUGA MENZIESII

A, H

 

4214

PSEUDOWINTERA COLORATA

A, H

Only for use when the plant part is leaf.

 

4215

PSIDIUM GUAJAVA

A, E, H

 

4216

PSORINUM

H

Only for use as an active homoeopathic ingredient. 

 

4217

PSYLLIUM HUSK DRY

A, H

When a dose for children is stated, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

 

4218

PSYLLIUM HUSK POWDER

A, E, H

When a dose for children is stated, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

 

4219

PSYLLIUM SEED DRY

A, E, H

When a dose for children is stated the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

 

4220

PTELEA TRIFOLIATA

A, H

 

4221

PTEROCARPUS MARSUPIUM

A, H

 

4222

PTEROCARPUS SANTALINUS

A, E, H

 

4223

PUERARIA LOBATA

A, E, H

 

4224

PUERARIA MONTANA VAR. LOBATA

A, E, H

 

4225

PULLULAN

E

 

4226

PUMICE

E

 

4227

PUMPKIN

E

 

4228

PUMPKIN SEED

E, H

 

4229

PUMPKIN SEED OIL

E, H

 

4230

PUNICA GRANATUM

A, E, H

 

4231

PURE BEE VENOM

H

Only for use as an active homoeopathic ingredient.

 

4232

PURIFIED HONEY

A, E

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

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

 

4233

PURIFIED SILICEOUS EARTH

E, H

 

4234

PURIFIED TALC

E

 

4235

PURIFIED WATER

E

 

4236

PVM/MA COPOLYMER

E

 

4237

PVM/MA DECADIENE CROSSPOLYMER

E

Only for use in topical medicines for dermal application.

 

4238

PVP/EICOSENE COPOLYMER

E

Only for use in topical medicines for dermal application.

 

4239

PVP/HEXADECENE COPOLYMER

E

Only for use in topical medicines for dermal application.

 

4240

PYRETHRINS

E

Only for use in topical medicines for dermal application.

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

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

- (PYRTH3) 'Contains pyrethrins [insert quantity]' (or words to that effect).

 

4241

PYRIDOXAL 5-PHOSPHATE

A, E

Pyridoxine is a mandatory component of Pyridoxal 5-phosphate.

The percentage of pyridoxine from pyridoxal 5-phosphate should be calculated based on the molecular weight of pyridoxal 5-phosphate.

The requirements specified in paragraphs (a) to (b) below apply to a medicine that contains the ingredient that is:

- listed in the Register before 1 March 2022; and

- released for supply before 1 March 2023.

(a) The maximum recommended daily dose must provide no more than 200 mg of pyridoxine.

(b) If the medicine contains more than 50 mg and no more than 200 mg of pyridoxine per maximum recommended daily dose the medicine requires the following warning statement on the medicine label:

- (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].'

The requirements specified in paragraphs (c) to (d) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2022; or

- released for supply on or after 1 March 2023.

(c) The maximum recommended daily dose of the medicine must not provide more than:

(i) 15 mg of pyridoxine for children aged between 1 and 3 years (inclusive);

(ii) 20 mg of pyridoxine for children aged between 4 and 8 years (inclusive);

(iii) 30 mg of pyridoxine for children aged between 9 and 13 years (inclusive);

(iv) 40 mg of pyridoxine for individuals aged 14 and 18 years (inclusive); and

(v) 100 mg of pyridoxine for individuals aged 19 years and older.

(d) If the maximum recommended daily dose of the medicine provides more than 10 mg of pyridoxine, the following warning statement is required on the medicine label:

- (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].'

 

4242

PYRIDOXAL 5-PHOSPHATE MONOHYDRATE

A

Pyridoxine is a mandatory component of Pyridoxal 5-phosphate monohydrate.

The percentage of pyridoxine from pyridoxal 5-phosphate monohydrate should be calculated based on the molecular weight of pyridoxal 5-phosphate monohydrate.

The requirements specified in paragraphs (a) to (b) below apply to a medicine that contains the ingredient that is:

- listed in the Register before 1 March 2022; and

- released for supply before 1 March 2023.

(a) The maximum recommended daily dose must provide no more than 200 mg of pyridoxine.

(b) If the medicine contains more than 50 mg and no more than 200 mg of pyridoxine per maximum recommended daily dose the medicine requires the following warning statement on the medicine label:

- (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].'

The requirements specified in paragraphs (c) to (d) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2022; or

- released for supply on or after 1 March 2023.

(c) The maximum recommended daily dose of the medicine must not provide more than:

(i) 15 mg of pyridoxine for children aged between 1 and 3 years (inclusive);

(ii) 20 mg of pyridoxine for children aged between 4 and 8 years (inclusive);

(iii) 30 mg of pyridoxine for children aged between 9 and 13 years (inclusive);

(iv) 40 mg of pyridoxine for individuals aged 14 and 18 years (inclusive); and

(v) 100 mg of pyridoxine for individuals aged 19 years and older.

(d) If the maximum recommended daily dose of the medicine provides more than 10 mg of pyridoxine, the following warning statement is required on the medicine label:

- (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].'

 

4243

PYRIDOXINE HYDROCHLORIDE

A, E, H

When not used as an active homoeopathic ingredient, pyridoxine is a mandatory component of Pyridoxine hydrochloride.

The percentage of pyridoxine from pyridoxine hydrochloride should be calculated based on the molecular weight of pyridoxine hydrochloride.

The requirements specified in paragraphs (a) to (b) below apply to a medicine that contains the ingredient that is:

- listed in the Register before 1 March 2022; and

- released for supply before 1 March 2023.

(a) The maximum recommended daily dose must provide no more than 200 mg of pyridoxine.

(b) If the medicine contains more than 50 mg and no more than 200 mg of pyridoxine per maximum recommended daily dose the medicine requires the following warning statement on the medicine label:

- (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].'

The requirements specified in paragraphs (c) to (d) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2022; or

- released for supply on or after 1 March 2023.

(c) The maximum recommended daily dose of the medicine must not provide more than:

(i) 15 mg of pyridoxine for children aged between 1 and 3 years (inclusive);

(ii) 20 mg of pyridoxine for children aged between 4 and 8 years (inclusive);

(iii) 30 mg of pyridoxine for children aged between 9 and 13 years (inclusive);

(iv) 40 mg of pyridoxine for individuals aged 14 and 18 years (inclusive); and

(v) 100 mg of pyridoxine for individuals aged 19 years and older.

(d) If the maximum recommended daily dose of the medicine provides more than 10 mg of pyridoxine, the following warning statement is required on the medicine label:

- (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].'

 

4244

PYROGLUTAMIC ACID

E

 

4245

PYROLA DECORATA

A, H

 

4246

PYROLIGNEOUS 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%.

 

4247

PYRROSIA LINGUA

A, H

 

4248

PYRROSIA PETIOLOSA

A, H

 

4249

PYRROSIA SHEARERI

A, H

 

4250

PYRUS COMMUNIS

A, E, H

Beta-arbutin is a mandatory component of Pyrus communis.

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

When for dermal application exclusively to the face:

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

b) hydroquinone is a mandatory component; and

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

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

 

4251

PYRUS PYRIFOLIA

A, H

Beta-arbutin is a mandatory component of Pyrus pyrifolia.

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

When for dermal application exclusively to the face:

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

b) hydroquinone is a mandatory component; and

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

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

 

4252

PYRUVIC 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%.

 

4253

QUASSIA

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%.

 

4254

QUASSIA AMARA

A, E, H

 

4255

QUASSIA WOOD JAMAICAN DRY

A, H

 

4256

QUASSIA WOOD JAMAICAN POWDER

A, H

 

4257

QUATERNIUM-15

E

Only for use in topical medicines for dermal application.

 

4258

QUATERNIUM-18 BENTONITE

E

Only for use in topical medicines for dermal application.

 

4259

QUATERNIUM-18 HECTORITE

E

Only for use in topical medicines for dermal application.

 

4260

QUATERNIUM-52

E

Only for use in wash-on/wash-off 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%.

Not be used in medicines in which N-nitroso compounds may be formed.

 

4261

QUATERNIUM-80

E

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

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

 

4262

QUERCETIN

A

 

4263

QUERCETIN DIHYDRATE

A

 

4264

QUERCUS ACUTISSIMA

A, H

 

4265

QUERCUS ALBA

A, E, H

 

4266

QUERCUS PALUSTRIS

A, H

 

4267

QUERCUS ROBUR

A, H

 

4268

QUERCUS RUBRA

A, H

 

4269

QUERCUS VIRGINIANA

A, H

 

4270

QUILLAIA DRY

A, H

 

4271

QUILLAIA POWDER

A, E, H

 

4272

QUILLAJA SAPONARIA

A, H

 

4273

QUINCE

E

 

4274

QUININE ARSENITE

H

Only for use as an active homoeopathic ingredient.

Quinine is a mandatory component of Quinine arsenite.

The maximum recommended daily dose must be no more than 50 mg of quinine.

 

4275

QUININE SULFATE DIHYDRATE

H

Only for use as an active homoeopathic ingredient. 

Quinine is a mandatory component of quinine sulfate dihydrate. 

The maximum recommended daily dose must be no more than 50 mg of quinine.

 

4276

QUINOLINE YELLOW

E

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

 

4277

QUINOLINE YELLOW ALUMINIUM LAKE

E

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

 

4278

QUISQUALIS INDICA

A, H

 

4279

R-ALPHA LIPOIC ACID

A

 

4280

RACEMENTHOL

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%.

 

4281

RACEMIC CAMPHOR

E, H

Only for use as an active homoeopathic or excipient ingredient.

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

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

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

 

4282

RADISH

E

 

4283

RAISIN JUICE CONCENTRATE

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%.

 

4284

RANUNCULUS BULBOSUS

A, H

 

4285

RANUNCULUS FICARIA

A, H

 

4286

RANUNCULUS TERNATUS

A, H

 

4287

RAPE SEED OIL

A, E, H

Allyl isothiocyanate is a mandatory component of rape seed oil when the plant part is seed.

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

 

4288

RAPHANUS SATIVUS

A, H

 

4289

RASPBERRY

E

 

4290

RASPBERRY BRANDY

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%.

 

4291

RASPBERRY DISTILLATE

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%.

 

4292

RASPBERRY FRUIT 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%.

 

4293

RASPBERRY JUICE CONCENTRATE

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%.

 

4294

RAUWOLFIA SERPENTINA

A, H

The concentration of equivalent dry Rauwolfia serpentina in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.

 

4295

RAUWOLFIA SERPENTINA DRY

A, H

The concentration of Rauwolfia Serpentina Dry in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.

 

4296

RAUWOLFIA SERPENTINA POWDER

A, H

The concentration of Rauwolfia Serpentina Powder in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.

 

4297

RED 27

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

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

 

4298

RED 27 ALUMINIUM LAKE

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

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

 

4299

RED ANT

H

Only for use as an active homoeopathic ingredient.

 

4300

RED CLOVER FLOWER DRY

A, H

 

4301

RED CLOVER FLOWER POWDER

A, H

 

4302

RED CORAL

H

Only for use as an active homoeopathic ingredient.

 

4303

RED DEER

A

 

4304

RED MERCURIC IODIDE

H

Only for use as an active homoeopathic ingredient.

 

4305

RED MERCURIC OXIDE

H

Only for use as an active homoeopathic ingredient.

 

4306

RED MERCURIC SULFIDE

H

Only for use as an active homoeopathic ingredient.

 

4307

REHMANNIA GLUTINOSA

A, E, H

 

4308

REL-1-((1R,2S)-1,2,3,4,5,6,7,8-OCTAHYDRO-1,2,8,8-TETRAMETHYL-2-NAPHTHALENYL)-1-ETHANONE

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%.

 

4309

RESORCINOL

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%.

 

4310

RESORCINOL DIMETHYLETHER

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%.

 

4311

RESVERATROL

A

Only permitted for use in medicines that are for oral routes of administration.

The maximum recommended daily dose of the medicine must not contain more than 150 milligrams of resveratrol.

The following warning statements are required on the medicine label:

- (RESVER) 'Resveratrol may affect the way some medicines work, including Warfarin. Consult your health professional before taking with other medicines (or words to that effect).';

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

- (CHILD2) ‘Not suitable for children’.

 

4312

RETINOL

A, E

Vitamin A is a mandatory component of retinol.

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

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

When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, 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.’

 

4313

RETINOL ACETATE

A, E

Vitamin A is a mandatory component of retinol acetate.

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

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

When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, 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.’

 

4314

RETINOL PALMITATE

A, E

Vitamin A is a mandatory component of retinol palmitate.

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

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

When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, 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.’

 

4315

REYNOUTRIA JAPONICA

A, E, H

When used as an excipient, only for use in topical medicines for dermal application.

 

4316

RHAMNOSE

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%.

 

4317

RHAMNUS CATHARTICA

A, H

When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rhamnus cathartica.

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'; and

- (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).

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)]'; and

- (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); and

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

 

4318

RHAMNUS FRANGULA

A, H

Glucofrangulins calculated as glucofrangulin A is a mandatory component of Rhamnus frangula.

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'; and

- (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).

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)]'; and

- (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); and

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

 

4319

RHATANY ROOT DRY

A, H

 

4320

RHATANY ROOT POWDER

A, H

 

4321

RHEUM OFFICINALE

A, E, H

The plant part must not be leaf.

When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum officinale.

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'; and

- (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).

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)]'; and

- (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); and

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

 

4322

RHEUM PALMATUM

A, E, H

The plant part must not be leaf.

When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum palmatum.

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’; and

- (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).

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)]’; and

- (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); and

- (LAX2) ‘Prolonged use may cause serious bowel problems’.

 

4323

RHEUM RHAPONTICUM

A, E, H

The plant part must not be leaf.

When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rheum rhaponticum.

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'; and

- (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).

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)]'; and

- (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); and

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

 

4324

RHEUM TANGUTICUM

A, H

The plant part must not be leaf.

When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum tanguticum.

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'; and

- (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).

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)]'; and

- (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); and

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

 

4325

RHODAMINE B

E

Permitted for use only as a colour for topical use.

 

4326

RHODINOL

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%.

 

4327

RHODINYL ACETATE

E

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

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

 

4328

RHODIOLA ROSEA

A

Only for use in oral medicines.

Only available for use when the plant preparation is dry root powder, dry root powder as an aqueous extract or dry root powder as a hydroethanolic extract with no more than 70% ethanol v/v.

 

4329

RHODODENDRON AUREUM

A, H

 

4330

RHODODENDRON FERRUGINEUM

A, H

Beta-arbutin is a mandatory component of Rhododendron ferrugineum.

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

When for dermal application exclusively to the face:

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

b) hydroquinone is a mandatory component; and

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

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

 

4331

RHODODENDRON GROENLANDICUM

A, H

 

4332

RHODODENDRON MOLLE

A, H

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

 

4333

RHUBARB

E, H

When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rhubarb.

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'; and

- (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).

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)]'; and

- (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); and

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

 

4334

RHUBARB ROOT DRY

A, H

When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of rhubarb root 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'; and

- (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).

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)]'; and

- (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); and

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

 

4335

RHUBARB ROOT POWDER

A, H

When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of rhubarb root 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'; and

- (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).

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)]'; and

- (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); and

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

 

4336

RHUS AROMATICA

A, E, H

 

4337

RHUS CHINENSIS

A, H

 

4338

RHUS GLABRA

A, E, H

 

4339

RHUS VENENATA

H

Only for use as an active homoeopathic ingredient.

 

4340

RIBES GROSSULARIA

A, E, H

 

4341

RIBES NIGRUM

A, E, H

 

4342

RIBOFLAVIN

A, E

 

4343

RIBOFLAVIN SODIUM PHOSPHATE

A, E

 

4344

RIBOFLAVIN TETRAACETATE

E

Only for use in topical medicines for dermal application.

 

4345

RIBOFLAVINE

A, E

 

4346

RIBOFLAVINE SODIUM PHOSPHATE

A, E

 

4347

RIBONUCLEIC ACID

E

Only for use in topical medicines for dermal application.

 

4348

RIBOSE

A

Only for use in oral medicines.

 

4349

RICE

E

 

4350

RICE BRAN

E

 

4351

RICE BRAN OIL

E

 

4352

RICE BRAN WAX

A, E, H

 

4353

RICE STARCH

E

 

4354

RICE VINEGAR

E

 

4355

RICE WINE

E

Ethanol is a mandatory component of rice wine.

 

4356

RICINOLEIC ACID

E

Only for use in topical medicines for dermal application.

 

4357

RICINUS COMMUNIS

A, H

Only for use when the plant part must be seed and the plant preparation is oil fixed.

 

4358

ROBINIA PSEUDOACACIA

A, E, H

When the herbal substance is derived from plant parts other than the leaf or flower, the maximum recommended daily dose of the medicine must be no more than 1mg of the dry herbal material.

 

4359

ROHDEA JAPONICA

A, H

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

 

4360

ROSA ARVENSIS

A, E, H

 

4361

ROSA CANINA

A, E, H

 

4362

ROSA CYMOSA

A, E, H

 

4363

ROSA EGLANTERIA

A, E, H

 

4364

ROSA GALLICA

A, E, H

 

4365

ROSA LAEVIGATA

A, E, H

 

4366

ROSA MULTIFLORA

A, E, H

 

4367

ROSA ROXBURGHII FRUIT 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 in the medicine must be no more than 0.002%.

 

4368

ROSA RUGOSA

A, E, H

 

4369

ROSA VILLOSA

A, E, H

 

4370

ROSA X CENTIFOLIA

A, E, H

 

4371

ROSA X DAMASCENA

A, E, H

 

4372

ROSANA

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%.

 

4373

ROSE 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%.

 

4374

ROSE FRUIT FRESH

A, E, H

 

4375

ROSE HIP

E

 

4376

ROSE OIL

A, E, H

 

4377

ROSE OXIDE

E

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

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

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

 

4378

ROSEMARY OIL

A, E, H

Safrole is a mandatory component of Rosemary oil.

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

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

 

4379

ROSMARINUS OFFICINALIS

A, E, H

Camphor and cineole are mandatory components of Rosmarinus officinalis.

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

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

When the concentration of cineole in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres.

In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container and include the following warning statements on the medicine label:

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

- (NTAKEN) 'Not to be taken'.

In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

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

- (NTAKEN) 'Not to be taken'.

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

 

4380

ROYAL JELLY

A, E

10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly.

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

- (CHILD2) 'Not suitable for children'

- (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.

 

4381

ROYAL JELLY FRESH

A, E

10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly fresh.

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

- (CHILD2) 'Not suitable for children'

- (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.

 

4382

ROYAL JELLY LYOPHILISED

A, E

10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly lyophilised.

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

- (CHILD2) 'Not suitable for children'

- (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.

 

4383

RUBBER NATURAL

E

Only for use in topical medicines for dermal application.

 

4384

RUBIA CORDIFOLIA

A, H

 

4385

RUBIA TINCTORUM

A, H

 

4386

RUBUS CHINGII

A, H

 

4387

RUBUS CORCHORIFOLIUS

A, H

 

4388

RUBUS COREANUS

A, E, H

 

4389

RUBUS FRUTICOSUS

A, E, H

 

4390

RUBUS IDAEUS

A, E, H

 

4391

RUBUS OCCIDENTALIS

A, E, H

 

4392

RUBUS PARVIFOLIUS

A, H

 

4393

RUBUS ROSIFOLIUS

A, H

 

4394

RUDBECKIA HIRTA

A, H

 

4395

RUE OIL

A, H

 

4396

RUM

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%.

 

4397

RUMEX ACETOSA

A, H

 

4398

RUMEX ACETOSELLA

A, H

 

4399

RUMEX CONGLOMERATUS

A, H

 

4400

RUMEX CRISPUS

A, E, H

 

4401

RUMEX PULCHER

A, H

 

4402

RUMEX SCUTATUS

A, H

 

4403

RUSCUS ACULEATUS

A, H

 

4404

RUTA GRAVEOLENS

A, E, H

 

4405

RUTOSIDE

A, E

 

4406

RYE

E

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

 

4407

RYE BRAN

E

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

 

4408

S-ISOPROPYL 3-METHYLTHIOCROTONATE

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%.

 

4409

SABINENE

E

Sabinene must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing sabinene must not be more than 5% of the total medicine.

 

4410

SABINENE HYDRATE

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%.

 

4411

SACCHARIDE ISOMERATE

E

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

The concentration in the medicine must be no more than 3.66%.

 

4412

SACCHARIN

E

 

4413

SACCHARIN SODIUM

E

 

4414

SACCHAROMYCES CEREVISIAE

A, E

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

 

4415

SACCHAROMYCES CEREVISIAE (BOULARDII)

A

 

4416

SACCHAROMYCES CERVISIAE POLYSACCHARIDES

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%.

 

4417

SACCHAROMYCES/ZINC FERMENT

E

Only for use in topical medicines for dermal application.

 

4418

SACCHARUM OFFICINARUM

A, E, H

 

4419

SAFFLOWER OIL

A, E, H

 

4420

SAFFRON

E

Permitted for use only as a colour for either topical use or with an oral route of administration.

 

4421

SAGE LEAF DRY

A, E, H

Thujone is a mandatory component of Sage leaf dry.

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

 

4422

SAGE LEAF POWDER

A, H

Thujone is a mandatory component of Sage leaf powder.

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

 

4423

SAGE OIL DALMATIAN

A

Thujone is a mandatory component of Sage oil dalmatian.

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

When the concentration of Sage oil dalmatian in the medicine is more than 10% and the nominal capacity of the container is no more than 15 mL, a restricted flow insert and child resistant closure must be  fitted on the container and the medicine requires the following warning statements on the medicine label:

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

- (NTAKEN) ‘Not to be taken’

 

4424

SAGE OIL SPANISH

A, E, H

 

4425

SALICORNIA EUROPAEA EXTRACT

E

Only for use in topical medicines for dermal use 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%.

 

4426

SALICYLALDEHYDE

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%.

 

4427

SALICYLIC ACID

E, H

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 40%.

 

4428

SALIX ALBA

A, E, H

 

4429

SALIX DAPHNOIDES

A, H

 

4430

SALIX DISCOLOR

A, H

 

4431

SALIX FRAGILIS

A, H

 

4432

SALIX NIGRA

A, H

 

4433

SALIX PURPUREA

A, H

 

4434

SALSOLA KALI

A, H

 

4435

SALVIA CHINENSIS

A, H

 

4436

SALVIA FRUTICOSA

A, H

 

4437

SALVIA HISPANICA

A, E, H

 

4438

SALVIA LAVANDULAEFOLIA

A, H

 

4439

SALVIA MILTIORRHIZA

A, H

 

4440

SALVIA OFFICINALIS

A, E, H

Thujone is a mandatory component of Salvia officinalis.

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

 

4441

SALVIA SCLAREA

A, E, H

 

4442

SAMBUCUS CANADENSIS

A, H

 

4443

SAMBUCUS EBULUS

A, H

 

4444

SAMBUCUS NIGRA

A, E, H

 

4445

SANDALWOOD OIL EAST INDIAN

A, E, H

 

4446

SANGUINARIA CANADENSIS

H

Only for use as an active homoeopathic ingredient.

The potency must be more than 4X.

 

4447

SANICULA EUROPAEA

A, H

 

4448

SANTALUM ALBUM

A, E, H

 

4449

SANTALUM SPICATUM

A, E, H

The route of administration must be topical or inhalation.

The plant preparation must be oil.

The plant part must be root or stem wood including heartwood.

 

4450

SAPINDUS MUKOROSSI

A, H

 

4451

SAPONARIA OFFICINALIS

A, H

 

4452

SAPOSHNIKOVIA DIVARICATA

A, H

 

4453

SARCOSINE

E

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

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

 

4454

SARGASSUM FUSIFORME

A, H

Iodine is a mandatory component of Sargassum fusiforme.

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.

 

4455

SARGASSUM SILIQUASTRUM

A, H

Iodine is a mandatory component of Sargassum siliquastrum.

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.

 

4456

SASSAFRAS ALBIDUM

A, H

Safrole is a mandatory component of Sassafras albidum.

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

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

 

4457

SATUREIA HORTENSIS

A, H

 

4458

SATUREIA MONTANA

A, H

 

4459

SAUROPUS SPATULIFOLIUS

A, H

 

4460

SAURURUS CHINENSIS

A, H

 

4461

SAUSSUREA COSTUS

A, H

 

4462

SAVORY OIL SUMMER

A, H

 

4463

SAXIFRAGA GRANULATA

A, E, H

 

4464

SAXIFRAGA STOLONIFERA

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 not be more than 0.0816%.

 

4465

SCAPHIUM SCAPHIGERUM

A, H

 

4466

SCHEFFLERA HEPTAPHYLLA

A, H

 

4467

SCHINOPSIS QUEBRACHO-COLORADO

A, H

 

4468

SCHINUS MOLLE

A, H

 

4469

SCHINUS MOLLE OIL

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%.

 

4470

SCHISANDRA CHINENSIS

A, E, H

 

4471

SCHIZONEPETA TENUIFOLIA

A, E, H

 

4472

SCHOENOCAULON OFFICINALE

A, H

The maximum recommended daily dose of the medicine must not contain more than the equivalent of 1 mg of the dry herbal material.

The concentration of total alkaloids of Schoenocaulon officinale in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

 

4473

SCLAREOL

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%.

 

4474

SCLAREOLIDE

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%.

 

4475

SCLERANTHUS ANNUUS

A, H

 

4476

SCLEROTIUM GUM

E

Only for use in topical medicines for dermal application.

 

4477

SCOPOLIA CARNIOLICA

A, H

The concentration of equivalent dry Scopolia carniolica in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.

 

4478

SCROPHULARIA NINGPOENSIS

A, H

 

4479

SCROPHULARIA NODOSA

A, H

 

4480

SCURRULA PARASITICA VAR. GRACILIFLORA

A, H

 

4481

SCUTELLARIA BAICALENSIS

A, E, H

 

4482

SCUTELLARIA BARBATA

A, H

 

4483

SCUTELLARIA LATERIFLORA

A, E, H

 

4484

SEA WHIP 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 in the medicine must be no more than 0.02%.

 

4485

SEC BUTYL 3-METHYLBUT-2-ENETHIOATE

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%.

 

4486

SEC-BUTYL THIOISOVALERATE

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%.

 

4487

SECALE CEREALE

A, H

Gluten is a mandatory component of Secale cereale when the plant part is seed and the route of administration is other than topical and mucosal.

 

4488

SEDUM ACRE

A, H

 

4489

SELAGINELLA TAMARISCINA

A, H

 

4490

SELENICEREUS GRANDIFLORUS

A, E, H

 

4491

SELENIUM

H

Only for use as an active homoeopathic ingredient.

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

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

- (SELE) 'This medicine contains selenium which is toxic in high doses.

A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.'

 

4492

SELENOCYSTEINE

A

Selenium is a mandatory component of Selenocysteine for oral and sublingual use.

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.'

 

4493

SELENOMETHIONINE

A

Selenium is a mandatory component of Selenomethionine for oral and sublingual use.

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 micograms for adults of selenium from dietary supplements should not be exceeded.’

 

4494

SELF-EMULSIFYING GLYCERYL MONOSTEARATE

E

 

4495

SEMECARPUS ANACARDIUM

A, H

When the plant part is other than seed, the maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material.

 

4496

SEMOLINA

E

 

4497

SEMPERVIVUM TECTORUM

A, H

 

4498

SENEGA ROOT DRY

A, H

 

4499

SENEGA ROOT POWDER

A, H

 

4500

SENNA ALEXANDRINA

A, H

When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna alexandrina.

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'; and

- (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).

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)]'; and

- (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); and

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

 

4501

SENNA FRUIT ALEXANDRIAN DRY

A, H

When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit alexandrian 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'; and

- (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).

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)]'; and

- (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); and

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

 

4502

SENNA FRUIT ALEXANDRIAN POWDER

A, H

When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit alexandrian 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'; and

- (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).

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)]'; and

- (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); and

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

 

4503

SENNA FRUIT TINNEVELLY DRY

A, H

When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit tinnevelly 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'; and

- (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).

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)]'; and

- (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); and

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

 

4504

SENNA FRUIT TINNEVELLY POWDER

A, H

When for oral or sublingual, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit tinnevelly 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'; and

- (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).

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)]'; and

- (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); and

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

 

4505

SENNA LEAF DRY

A, H

When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna leaf 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'; and

- (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).

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); and

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

 

4506

SENNA LEAF POWDER

A, H

When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna Leaf 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'; and

- (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).

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)]'; and

- (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); and

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

 

4507

SENNA OCCIDENTALIS

A, H

Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna occidentalis when the route of administration is oral administration.

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'; and

- (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].

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)]'; and

- (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 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]; and

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

 

4508

SENNA TORA

A, H

When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna tora.

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'; and

- (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).

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)]'; and

- (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); and

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

 

4509

SEPIA

H

Only for use as an active homoeopathic ingredient.

The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2022; or

- released for supply on or after 1 March 2023.

(a) The following warning statement is required on the medicine label:

- (MOLLUSC) ‘Contains mollusc’ or ’Contains mollusc products’.

 

4510

SEQUOIA SEMPERVIRENS

A, H

 

4511

SEQUOIADENDRON GIGANTEUM

A, H

 

4512

SERENOA REPENS

A, H

 

4513

SERINE

A, E

 

4514

SERUM ANGUILLAE

H

Only for use as an active homoeopathic ingredient. 

 

4515

SESAME OIL

A, E, H

 

4516

SESAME SEED

E

 

4517

SESAMUM INDICUM

A, E, H

 

4518

SETARIA ITALICA

A, H

 

4519

SHARK CALCIUM CHONDROITIN SULFATE

A

 

4520

SHARK CARTILAGE

A, E

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

- (SHARK) 'Children, pregnant or breastfeeding women, and those who have recently had a heart attack, surgery or a major accident should not consume this product without medical advice' (or words to that effect)

 

4521

SHARK CHONDROITIN SULFATE

A, E

When used as an excipient:

- only for use in topical medicines for dermal application;

- not to be included in medicines intended for use in the eye; and

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

 

4522

SHARK POTASSIUM CHONDROITIN SULFATE

A

 

4523

SHARK SODIUM CHONDROITIN SULFATE

A, E

When used as an excipient:

- only for use in topical medicines for dermal application;

- not to be included in medicines intended for use in the eye; and

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

 

4524

SHARK-LIVER OIL

A, E

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

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

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

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

When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, 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.’

 

4525

SHEA BUTTER

E

 

4526

SHEA BUTTER ETHYL ESTERS

E

Shea butter ethyl esters must:

(a) Only be used in topical medicines for dermal application; and

(b) Not be included in medicines intended for use on broken skin.

The total concentration of shea butter ethyl esters in the medicine must not be more than 30%.

 

 

4527

SHEA BUTTER UNSAPONIFIABLES

E

Only for use in topical medicines for dermal application.

 

4528

SHELLAC

E

 

4529

SHEPHERD'S PURSE HERB DRY

A, H

 

4530

SHEPHERD'S PURSE HERB POWDER

A, H

 

4531

SHERRY WINE

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%.

 

4532

SIGESBECKIA ORIENTALIS

A, E, H

 

4533

SILICA

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%.

 

4534

SILICA DIMETHYL SILYLATE

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%.

 

4535

SILICA SILYLATE

E

Only for use in topical medicines for dermal application.

 

4536

SILICIFIED MICROCRYSTALLINE CELLULOSE

E

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

 

4537

SILICON DIOXIDE

A, E, H

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

 

4538

SILICONE QUATERNIUM-8

E

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

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

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

- (EYE) 'Avoid contact with eyes' (or words to that effect).

 

4539

SILVER

H

Only for use as an active homoeopathic ingredient.

When for external use, the total concentration of silver in the medicine must not be more than 1%.

When for oral use:

(a) the total concentration of silver in the medicine must not be more than 0.3%; and

(b) the following warning statement is required on the medicine label:

- ‘Overuse may stain skin or mouth.’ (or words to that effect).

 

4540

SILVER BEET

E, H

 

4541

SILVER BOROSILICATE

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 should be no more than 0.6%.  

Silver is a mandatory component of Silver borosilicate when the route of administration is topical.

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

 

4542

SILVER NITRATE

H

Only for use as an active homoeopathic ingredient. 

 

4543

SILYBUM MARIANUM

A, E, H

 

4544

SIMABA CEDRON

A, H

 

4545

SIMETHICONE

E

 

4546

SIMMONDSIA CHINENSIS

A, E, H

 

4547

SINAPIS ALBA

A, H

Allyl isothiocyanate is a mandatory component of Sinapis alba when the plant part is seed.

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

 

4548

SINAPIS ARVENSIS

A, H

 

4549

SINOMENIUM ACUTUM

A, H

 

4550

SIPHONESTEGIA CHINENSIS

A, H

 

4551

SIRAITIA GROSVENORII

A, E, H

 

4552

SISYMBRIUM OFFICINALE

A, H

 

4553

SKATOLE

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%.

 

4554

SKIPJACK-LIVER OIL

A, E

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

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

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

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

When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, 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.’

 

4555

SLIPPERY ELM BARK DRY

A, H

 

4556

SLIPPERY ELM BARK POWDER

A, E, H

 

4557

SMILAX ARISTOLOCHIIFOLIA

A, H

 

4558

SMILAX CHINA

A, H

 

4559

SMILAX GLABRA

A, H

 

4560

SMILAX OFFICINALIS

A, E, H

 

4561

SMILAX ORNATA

A, E, H

 

4562

SMOKE 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%.

 

4563

SODIUM ACETATE

E

 

4564

SODIUM ACETYLATED HYALURONATE

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%.

 

4565

SODIUM ACID CITRATE

A, E, H

When sodium acid citrate is used as an active ingredient, only for use in oral medicines.

 

4566

SODIUM ACRYLATES COPOLYMER

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 0.8%.

 

4567

SODIUM ACRYLATES CROSSPOLYMER-2

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 0.7 % (w/w).

 

4568

SODIUM ACRYLOYDIMETHYLTAURATE/VP CROSSPOLYMER

E

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

The concentration in the medicine must be no more than 2% (w/w).

 

4569

SODIUM ALGINATE

E

 

4570

SODIUM ASCORBATE

A, E, H

 

4571

SODIUM ASCORBYL PHOSPHATE

E

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

When used in a sunscreen, the concentration in the medicine must be no more than 0.1%.

 When used in products other than sunscreens, the concentration in the medicine must be no more than 0.5%.

 

4572

SODIUM ASCORBYL/CHOLESTERYL PHOSPHATE

E

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

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

 

4573

SODIUM BENZOATE

E

 

4574

SODIUM BETA-HYDROXY-BETA-METHYLBUTYRATE

A, H

 

4575

SODIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE

A, H

 

4576

SODIUM BICARBONATE

A, E

When used as an active ingredient, the medicine may only be for oral rehydration salts in powdered and effervescent tablet dosage forms.

Medicines containing sodium bicarbonate for use as oral rehydration therapy are subject to the following conditions:

a) the medicine complies with the requirements specified in the British Pharmacopoeia, as in force or existing from time to time, for Oral Rehydration Salts;

b) the sodium content and total osmolarity of the solution after it has been prepared according to the instructions on the packet are consistent with the criteria specified by the World Health Organisation (WHO) and the United Nations Childrens Fund (UNICEF) in the document 'Expert consultation on oral rehydration salts formulation 18 July 2001.'

c) the following warning statements are required on the medicine label:

- (UOAD) 'Use only as directed.'

- (DIAR) 'If diarrhoea persists for more than 6 hours in infants under 6 months - 12 hours in children under 3 years - 24 hours in children aged 3-6 years or 48 hours in adults and children over 6 years - seek medical advice (or words to that effect).'

- (DIAR3) 'If diarrhoea persists, seek medical advice.'

 

4577

SODIUM BISULFITE

E

 

4578

SODIUM BROMIDE

H

Only for use as an active homoeopathic ingredient.

The total concentration of sodium bromide in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

 

4579

SODIUM BUTYRATE

A, E

The route of administration for medicines that contain sodium butyrate must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than 1200 mg sodium butyrate.

The following warning statement (or words to the same effect) is required on the medicine label:

- (ADULT) 'Adults only’.

 

4580

SODIUM C14-16 OLEFIN SULFONATE

E

Only for use in topical medicines for dermal application.

 

4581

SODIUM CALCIUM EDETATE

E

When for oral use, sodium is a mandatory component of sodium calcium edetate.

Sodium calcium edetate must only be included in medicines when:

(a) the route of administration is limited to topical for dermal use; or

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

The total concentration of sodium calcium edetate in the medicine must not exceed 0.32%.

The total concentration of flavour proprietary excipient formulations containing sodium calcium edetate must not be more than 5% of the total medicine.

 

4582

SODIUM CARBOMER

E

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

 

4583

SODIUM CARBONATE

E

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

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

 

4584

SODIUM CARBONATE MONOHYDRATE

E

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

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

 

4585

SODIUM CARBOXYMETHYL BETAGLUCAN

E

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

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

 

4586

SODIUM CARRAGEENAN

E

 

4587

SODIUM CASEINATE

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%.

 

4588

SODIUM CETOSTEARYL SULFATE

E

Only for use in topical medicines for dermal application.

 

4589

SODIUM CHLORIDE

A, E, H

 

4590

SODIUM CHONDROITIN SULFATE

A, E

When used as an excipient ingredient:

a) only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye;

b) the concentration in the medicine must not be more than 0.001%.

When used as an active ingredient:

a) the route of administration must only be oral;

b) the maximum daily dose must not provide more than 1,200 mg of sodium chondroitin sulfate;

c) the following statements must be included on the medicine label:

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

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

 

4591

SODIUM CITRATE

A, E

When for use as an active ingredient, only for oral use.

 

4592

SODIUM CITRATE DIHYDRATE

A, E

When for use as an active ingredient, only for oral use.

 

4593

SODIUM COCO PG-DIMONIUM CHLORIDE PHOSPHATE

E

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

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

 

4594

SODIUM COCOAMPHOACETATE

E

Only for use in topical medicines for dermal application.

 

4595

SODIUM COCOYL SARCOSINATE

E

Only for use in topical medicines for dermal application.

 

4596

SODIUM CYCLAMATE

E

 

4597

SODIUM DEHYDROACETATE

E

Only for use in topical medicines for dermal application.

 

4598

SODIUM DNA

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%.

 

4599

SODIUM DODECYLBENZENESULFONATE

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 30%.

 

4600

SODIUM ERYTHORBATE

E

 

4601

SODIUM ETHYL HYDROXYBENZOATE

E

 

4602

SODIUM FLUORIDE

A, E, H

Fluoride is a mandatory component of sodium fluoride.

The route of administration must be limited to dental.

The dosage form must be limited to pastes, powders and/or gels for dental hygiene.

When used as an active ingredient, the medicine is subject to the following conditions:

(a) only for use in combination with at least one other active ingredient; and

(b) the concentration of fluoride ion in the medicine must not be more than 1,500 mg/kg.

When the concentration of fluoride ion is more than 1000 mg/kg, the medicine requires the following statements on the medicine label:

- (DNTSW) 'Do not swallow.'

- (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less.'

 

4603

SODIUM FUMARATE

E

 

4604

SODIUM HYALURONATE

A, E

When for use as an excipient ingredient, sodium hyaluronate must only be used in medicines with a topical route of administration for dermal application.

When for use as an active ingredient:

(a) the molecular mass of sodium hyaluronate must be between 600 and 1600 kilodaltons; and

(b) sodium hyaluronate must only be used in medicines when the route of administration is limited to:

(i) topical for dermal application; or

(ii) oral.

When for use in a topical medicine for dermal application the concentration of sodium hyaluronate in the medicine must not exceed 2.0%.

When for use as an active ingredient and the route of administration is oral:

(a) the maximum recommended daily dose must not provide more than 200 milligrams sodium hyaluronate;

(b) the recommended duration of use of the medicine must be limited to three months; and

(c) the following warning statements (or words to the same effect) are required on the medicine label :

- (ADULT) 'Adults only’; and

- (PREGNT) ' Not recommended for use by pregnant and lactating women'.

 

4605

SODIUM HYDROGENATED TALLOW GLUTAMATE

E

Only for use in topical medicines for dermal application.

 

4606

SODIUM HYDROXIDE

E

The concentration of sodium hydroxide in the medicine must not be more than 5%.

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

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

 

4607

SODIUM HYDROXYCITRATE

A

 

4608

SODIUM HYDROXYETHYL ACRYLATE/ACRYLOYLDIMETHYL TAURATE COPOLYMER

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 1.5%.

 

4609

SODIUM HYDROXYMETHYLGLYCINATE

E

Only for use in topical medicines for dermal application.

 

4610

SODIUM HYPOCHLORITE

E

Chlorine is a mandatory component of sodium hypochlorite.

The concentration of chlorine in the medicine must not be more than 4%.

 

4611

SODIUM ISOSTEAROYL LACTYLATE

E

Only for use in topical medicines for dermal application.

 

4612

SODIUM LACTATE

E

 

4613

SODIUM LAURETH SULFATE

E

 

4614

SODIUM LAUROAMPHOACETATE

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%.

 

4615

SODIUM LAUROYL METHYL ISETHIONATE

E

Only for use in wash-off 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 11%.

 

4616

SODIUM LAUROYL SARCOSINATE

E

Only for use in topical medicines for dermal application.

 

4617

SODIUM LAURYL PHOSPHATE

E

 

4618

SODIUM LAURYL SULFATE

E

 

4619

SODIUM LAURYL SULFOACETATE

E

Only for use in topical medicines for dermal application.

 

4620

SODIUM MAGNESIUM SILICATE

E

Only for use in topical medicines for dermal application.

 

4621

SODIUM MANNOSE PHOSPHATE

E

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

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

 

4622

SODIUM METABISULFITE

E

 

4623

SODIUM METAPHOSPHATE

E

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

The concentration in the medicine must not be more than 0.1%.

 

4624

SODIUM METHYL COCOYL TAURATE

E

Only for dental use.

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

 

4625

SODIUM METHYL HYDROXYBENZOATE

E

 

4626

SODIUM MOLYBDATE DIHYDRATE

A

Only for use in oral medicines.

Molybdenum is a mandatory component of Sodium molybdate dihydrate.

The percentage of molybdenum from sodium molybdate dihydrate should be calculated based on the molecular weight of sodium molybdate dihydrate.

The maximum daily dose of molybdenum from Sodium molybdate dihydrate must be no more than 125 micrograms.

 

4627

SODIUM MONOFLUOROPHOSPHATE

A

Fluoride is a mandatory component of sodium monofluorophosphate.

The route of administration must be limited to dental.

The dosage form must be limited to pastes, powders and/or gels for dental hygiene.

When sodium monofluorophosphate is used as an active ingredient, it is subject to the following conditions:

(a) only for use in combination with at least one other active ingredient; and

(b) the concentration of fluoride ion in the medicine must not be more than 1,500 mg/kg.

When the concentration of fluoride ion is more than 1000 mg/kg, the following warning statements are required on the medicine label:

- (DNTSW) 'Do not swallow.'

- (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less.'

 

4628

SODIUM MYRISTOYL GLUTAMATE

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 0.0164%.

 

4629

SODIUM NITRATE

H

Only for use as an active homoeopathic ingredient.

 

4630

SODIUM NONOXYNOL-4 SULFATE

E

Only for use in topical medicines for dermal application.

 

4631

SODIUM PANTOTHENATE

A, E, H

 

4632

SODIUM PCA

E

Only for use in topical medicines for dermal application.

 

4633

SODIUM PERBORATE

A, H

Boron is a mandatory component of sodium perborate.

When for internal use, the maximum recommended daily dose must not provide more than 6 mg of boron.

When used in preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron from all ingredients in the product must not exceed 3500 mg/kg or 3500 mg/L or 0.35%.

When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label:

- (NTAKEN12) 'Not to be taken by children under 12 years old' (or words to that effect); or

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

When the maximum recommended daily dose of the medicine provides more than 1 mg boron and up to, and including, 3 mg of boron, and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label:

- (NTAKEN2) 'Not to be taken by children under 2 years old' (or words to that effect); or

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

When for excipient use and the maximum recommended daily dose of the medicine provides more than 1 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:

- (BORON) 'Contains boron' (or words to that effect).

When the medicine is for topical use for dermal application, the following warning statement is required on the label:

- (BROKEN) 'Use on unbroken skin only' (or words to that effect).

 

4634

SODIUM PERCARBONATE

E

Only for use in topical medicines for dermal application.

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

 

4635

SODIUM POLYACRYLATE

E

Only for use in topical medicines for dermal application.

 

4636

SODIUM POLYACRYLATE STARCH

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 not be more than 1%.

 

4637

SODIUM POLYMETAPHOSPHATE

E

 

4638

SODIUM PROPIONATE

E

 

4639

SODIUM PROPYL HYDROXYBENZOATE

E

 

4640

SODIUM RNA

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 0.2%.

 

4641

SODIUM SELENATE

A, H

Selenium is a mandatory component of sodium selenate.

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

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

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

 

4642

SODIUM SELENATE DECAHYDRATE

A

Selenium is a mandatory component of sodium selenate decahydrate.

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

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

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

 

4643

SODIUM SELENITE

A, H

Selenium is a mandatory component of Sodium selenite.

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

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

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

 

4644

SODIUM SELENITE PENTAHYDRATE

A

Selenium is a mandatory component of Sodium selenite pentahydrate.

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

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

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

 

4645

SODIUM SILICATE

E

 

4646

SODIUM STARCH GLYCOLLATE

E

 

4647

SODIUM STARCH GLYCOLLATE TYPE A

E

 

4648

SODIUM STEARATE

E

Only for use in topical medicines for dermal application.

 

4649

SODIUM STEAROXY PG-HYDROXYETHYLCELLULOSE SULFONATE

E

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

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

 

4650

SODIUM STEAROYL GLUTAMATE

E

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

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

 

4651

SODIUM STEAROYL LACTYLATE

E

Only for use in topical medicines for dermal application.

 

4652

SODIUM STEARYL PHTHALAMATE

E

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

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

 

4653

SODIUM SUCCINATE

E

Only for use in topical medicines for dermal application.

 

4654

SODIUM SULFATE

A, E, H

When it is not intended to be a laxative, the following warning statement is required on the medicine label:

- (LAX4) 'Substance may have a laxative effect'.

 

4655

SODIUM SULFATE DECAHYDRATE

A, E, H

When it is not intended to be a laxative, the following warning statement is required on the medicine label:

- (LAX4) 'Substance may have a laxative effect'.

 

4656

SODIUM SULFITE

E

 

4657

SODIUM SULFITE HEPTAHYDRATE

E

Only for use in topical medicines for dermal application.

 

4658

SODIUM TRIPOLYPHOSPHATE

E

Only for use when the route of administration is topical for dermal application, mucous membrane (buccal mucosa) or dental.

Not to be included in topical medicines intended for use in the eye.

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

 

4659

SOLANUM DULCAMARA

A, H

When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum dulcamara.

When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.

 

4660

SOLANUM FEROX

A, H

When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum ferox.

When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.

 

4661

SOLANUM LYCOCARPUM FRUIT EXTRACT

E

Only for use in topical medicines for dermal use 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%.

 

4662

SOLANUM MELONGENA

A, H

When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum melongena.

When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.

 

4663

SOLANUM NIGRUM

A, H

When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum nigrum.

When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.

 

4664

SOLANUM TUBEROSUM

A, H

When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum tuberosum.

When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.

 

4665

SOLIDAGO GIGANTEA

A, H

 

4666

SOLIDAGO GIGANTEA MIS

A, E, H

 

4667

SOLIDAGO VIRGAUREA

A, E, H

 

4668

SOLUBLE MAIZE STARCH

E

 

4669

SOLUBLE POTATO STARCH

E

 

4670

SOLVENT GREEN 3

E

Permitted for use only as a colour for topical use.

 

4671

SOLVENT RED 1

E

Permitted for use only as a colour for topical use.

 

4672

SOLVENT VIOLET 13

E

Permitted for use only as a colour for topical use.

 

4673

SOLVENT YELLOW 172

E

Permitted for use only as a colour for topical use.

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

 

4674

SOLVENT YELLOW 33

E

Permitted for use only as a colour for topical use.

 

4675

SOPHORA FLAVESCENS

A, E, H

 

4676

SOPHORA TONKINENSIS

A, H

 

4677

SORBIC ACID

E

 

4678

SORBITAN ISOSTEARATE

E

Only for use in topical medicines for dermal application.

 

4679

SORBITAN MONO-OLEATE

E

 

4680

SORBITAN MONOLAURATE

E

 

4681

SORBITAN MONOSTEARATE

E

 

4682

SORBITAN OLEATE

E

 

4683

SORBITAN OLIVATE

E

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

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

 

4684

SORBITAN PALMITATE

E

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

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

 

4685

SORBITAN SESQUIISOSTEARATE

E

Only for use in topical medicines for dermal application.

 

4686

SORBITAN SESQUIOLEATE

E

Only for use in topical medicines for dermal application.

 

4687

SORBITAN STEARATE

E

 

4688

SORBITAN TRISTEARATE

E

Only for use in topical medicines for dermal application.

 

4689

SORBITOL

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.

 

4690

SORBITOL SOLUTION (70 PER CENT) (CRYSTALLISING)

A, E

Sorbitol is a mandatory component of sorbitol solution (70 per cent) (crystallising).

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.

 

4691

SORBITOL SOLUTION (70 PER CENT) (NON-CRYSTALLISING)

A, E

Sorbitol is a mandatory component of sorbitol solution (70 per cent) (non-crystallising).

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.

 

4692

SORBUS AUCUPARIA

A, H

 

4693

SORGHUM

E

 

4694

SORGHUM VULGARE

A, H

 

4695

SOY PHOSPHATIDYLSERINE-ENRICHED SOY LECITHIN LIQUID

A

Soy phosphatidylserine is a mandatory component of soy phosphatidylserine-enriched soy lecithin liquid.

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

 

4696

SOY PHOSPHATIDYLSERINE-ENRICHED SOY LECITHIN POWDER

A

Soy phosphatidylserine is a mandatory component of soy phosphatidylserine-enriched soy lecithin powder.

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

 

4697

SOY POLYSACCHARIDE

E

 

4698

SOY PROTEIN

E

 

4699

SOY STEROL

E

 

4700

SOYA BEAN

E

 

4701

SOYA BRAN

E

 

4702

SOYA OIL

A, E, H

 

4703

SOYBEAN FLOUR

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%.

 

4704

SOYBEAN 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 4%.

 

4705

SPARGANIUM STOLONIFERUM

A, H

 

4706

SPARTIUM JUNCEUM

A, H

 

4707

SPATHOLOBUS SUBERECTUS

A, H

 

4708

SPEARMINT OIL

A, E, H

Menthol is a mandatory component of spearmint oil.

When the medicine is for topical use for dermal application:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(iii) the following warning statement is required on the medicine label:

- (EYE) Avoid contact with eyes (or words to that effect).

(iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

(v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

 

4709

SPEARMINT OIL TERPENELESS

E

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

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

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

Menthol is a mandatory component of spearmint oil terpeneless.

When the medicine is for topical use for dermal application:

i) the medicine must not be intended for use in the eye or on damaged skin;

ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

iii) the following warning statement is required on the medicine label:

- (EYE) Avoid contact with eyes (or words to that effect).

iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

 

4710

SPHINGOLIPIDS

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%.

 

4711

SPIGELIA ANTHELMIA

A, H

 

4712

SPIGELIA MARILANDICA

A, H

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

 

4713

SPIKE LAVENDER OIL

A, E, H

Camphor is a mandatory component of spike lavender oil.

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

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

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

 

4714

SPINACH

E

 

4715

SPINACIA OLERACEA

A, E, H

 

4716

SPIRODELA POLYRRHIZA

A, H

 

4717

SPIRULINA

E

 

4718

SPRAY-DRIED GLUCOSE SYRUP

E

Permitted for use as an excipient for oral routes of administration.

 

4719

SPRAY-DRIED LIQUID GLUCOSE

E

Permitted for use as an excipient for oral routes of administration.

 

4720

SPRUCE 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%.

 

4721

SQUALANE

E

Only for use in topical medicines for dermal application.

 

4722

SQUALENE

A, E

 

4723

SQUID OIL

A

Only for use in oral medicines.

Must be obtained from species of the order Teuthida of the class Cephalopoda, be used in combination with other ingredients in the medicine and be presented in a therapeutic dosage form for therapeutic use.

The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that is:

- listed in the Register before 1 March 2022; and

- released for supply before 1 March 2023.

(a) The medicine requires one of the following warning statements on the medicine label:

- (SFOOD) 'Derived from seafood'; or

- (MOLLUSC) ‘Contains mollusc’ or ’Contains mollusc products’.

The requirement specified in paragraph (b) below applies to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2022; or

- released for supply on or after 1 March 2023.

(b) The following warning statement is required on the medicine label:

- (MOLLUSC) ‘Contains mollusc’ or ’Contains mollusc products’.

 

4724

SQUILL DRY

A, H

 

4725

SQUILL INDIAN DRY

A, H

 

4726

SQUILL INDIAN POWDER

A, H

 

4727

SQUILL POWDER

A, H

 

4728

ST JOHN'S WORT DRY EXTRACT QUANTIFIED

A

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.'

 

4729

ST JOHN'S WORT HERB DRY

A, 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.'

 

4730

ST JOHN'S WORT HERB POWDER

A, 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.'

 

4731

STACHYS OFFICINALIS

A, E, H

 

4732

STACHYS PALUSTRIS

A, H

 

4733

STACHYURUS HIMALAICUS

A, H

 

4734

STANNIC OXIDE

E

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

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

 

4735

STANNOUS CHLORIDE

H

Only for use as an active homoeopathic ingredient. 

 

4736

STAR ANISE OIL

A, E

When the total concentration of star anise oil in the medicine is more than 50%:

(a) the nominal capacity of the container must not be more than 50 mL;

(b) a restricted flow insert must be fitted on the container; and

(c) the following warning statement is required on the medicine label:

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

 

4737

STARCH

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%.

 

4738

STARCH SODIUM OCTENYL SUCCINATE

E

 

4739

STEARALKONIUM CHLORIDE

E

Only for use in topical medicines for dermal application.

 

4740

STEARALKONIUM HECTORITE

E

Only for use in topical medicines for dermal application.

 

4741

STEARAMIDE

E

Only for use in topical medicines for dermal application.

 

4742

STEARAMIDOETHYL DIETHYLAMINE

E

Only for use in topical medicines for dermal application.

 

4743

STEARAMIDOPROPYL DIMETHYLAMINE

E

Only for use in topical medicines for dermal application.

 

4744

STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE

E

Only for use in topical medicines for dermal application.

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

When the medicine is intended to be used on the eye, the medicine requires the following warning statement on the medicine label:

- (EYE2) 'May be irritant to the eyes' (or words to that effect).

 

4745

STEARETH-10

E

Only for use in topical medicines for dermal application.

 

4746

STEARETH-100

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 1.5%.

 

4747

STEARETH-2

E

Only for use in topical medicines for dermal application.

 

4748

STEARETH-20

E

Only for use in topical medicines for dermal application.

 

4749

STEARETH-21

E

Only for use in topical medicines for dermal application.

 

4750

STEARETH-5

E

Only for use in topical medicines for dermal application.

 

4751

STEARIC ACID

E

 

4752

STEAROPTENES

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%.

 

4753

STEAROXY DIMETHICONE

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%.

 

4754

STEAROXYTRIMETHYLSILANE

E

Only for use in topical medicines for dermal application.

 

4755

STEAROYL MACROGOLGLYCERIDES

E

Only for use in oral medicines.

The concentration in the medicine must be no more than 0.6%.

 

4756

STEARYL ACETATE

E

Only for use in topical medicines for dermal application.

 

4757

STEARYL ALCOHOL

E

 

4758

STEARYL BEHENATE

E

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

The concentration in the medicine must not be more than 3.5% in the final formulation.

 

4759

STEARYL DIMETHICONE

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 4.5%.

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

- (EYE2) 'May be irritant to the eyes' (or words to that effect)

- (EYE) 'Avoid contact with eyes' (or words to that effect).

 

4760

STEARYL GLYCYRRHETINATE

E

Only for use in topical medicines for dermal application.

 

4761

STEARYL HEPTANOATE

E

Only for use in topical medicines for dermal application.

 

4762

STEARYL MYRISTATE

E

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

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

 

4763

STEARYL STEARATE

E

Only for use in topical medicines for dermal application.

 

4764

STELLARIA CHAMAEJASME

A, H

 

4765

STELLARIA DICHOTOMA

A, H

 

4766

STELLARIA MEDIA

A, E, H

 

4767

STEMONA JAPONICA

A, H

 

4768

STEMONA SESSILIFOLIA

A, H

 

4769

STENOTAPHRUM SECUNDATUM

A, H

 

4770

STEPHANIA TETRANDA

A, H

 

4771

STERCULIA

A, H

 

4772

STERCULIA TRAGACANTHA

A, H

 

4773

STERCULIA URENS

A, H

 

4774

STEVIA REBAUDIANA

A, E, H

 

4775

STEVIOL GLYCOSIDES

E

Only for use in oral medicines.

 

4776

STILLINGIA SYLVATICA

A, H

 

4777

STORAX PREPARED

A, E, H

 

4778

STRAWBERRY

E

 

4779

STRAWBERRY ESSENCE

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%.

 

4780

STREPTOCOCCUS SALIVARIUS

A

Only permitted for use in medicines:

- that are for oral routes of administration; and

- when the strain of Streptococcus salivarius is confirmed to be K12 or M18.

The name of the Streptococcus salivarius strain must be declared on the label.

The following warning statement is required on the medicine label:

- (CHILD5) 'Use in children under 3 years is not recommended'.

 

4781

STREPTOCOCCUS THERMOPHILUS

A

 

4782

STROBILANTHES CUSIA

A, H

 

4783

STRONG AMMONIA SOLUTION

E

Ammonia is a mandatory component of strong ammonia solution.

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

When for internal use, the concentration in the medicine must be no more than 0.25%.

 

4784

STRONTIUM CARBONATE

H

Only for use as an active homoeopathic ingredient. 

 

4785

STROPHANTHUS GRATUS

H

Only for use as an active homoeopathic ingredient.

 

4786

STROPHANTHUS HISPIDUS

H

Only for use as an active homoeopathic ingredient.

 

4787

STRYCHNOS IGNATII

H

Only for use as an active homoeopathic ingredient. 

Strychnine (of Strychnos spp.) is a mandatory component of Strychnos ignatii.

The concentration of Strychnine (of Strychnos spp.) must be no more than 1 milligram/Kg or 1 milligram/L or 0.1%.

 

4788

STRYCHNOS NUX-VOMICA

A, H

Strychnine (of Strychnos spp.) is a mandatory component of Strychnos nux-vomica.

The concentration of Strychnine (of Strychnos spp.) must be no more than 1 milligram/Kg or 1 milligram/L or 0.1%.

 

4789

STYPHNOLOBIUM JAPONICUM

A, E, H

 

4790

STYRALLYL PROPIONATE

E

Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.

 

4791

STYRAX BENZOIN

A, E, H

 

4792

STYRAX 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%.

 

4793

STYRAX PARALLELONEURUM

A, H

 

4794

STYRAX TONKINENSIS

A, H

 

4795

STYRENE

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%.

The total concentration of styrene in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

 

4796

STYRENE/ACRYLATES COPOLYMER

E

Only for use in topical medicines for dermal application.

 

4797

STYROLYL 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%.

 

4798

SUBLIMED SULFUR

H

Only for use as an active homoeopathic ingredient. 

 

4799

SUCCINIC ACID

E

 

4800

SUCRALOSE

E

 

4801

SUCROSE

E

 

4802

SUCROSE ACETATE 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%.

 

4803

SUCROSE ACETATE PALMITATE STEARATE

E

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

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

 

4804

SUCROSE COCOATE

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%.

 

4805

SUCROSE DISTEARATE

E

Only for use in topical medicines for dermal application.

 

4806

SUCROSE LAURATE

E

When for oral or sublingual use, sucrose is a mandatory component of sucrose laurate.

 

4807

SUCROSE OCTAACETATE

E

When for oral or sublingual use, sucrose is a mandatory component of sucrose octaacetate.

 

4808

SUCROSE PALMITATE

E

Only for use in topical medicines for dermal application.

 

4809

SUCROSE POLYCOTTONSEEDATE

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%.

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

- (EYE) 'Avoid contact with the eyes' (or words to that effect)

- (EYE2) 'May be irritant to the eyes' (or words to that effect).

 

4810

SUCROSE STEARATE

E

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

When for topical use, the concentration in the medicine must be no more than 0.25%.

For oral use as a manufacturing aid only.

When for oral use, the concentration in the medicine must be no more than 0.2 mg per dosage unit.

 

4811

SUCROSE TRISTEARATE

E

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

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

 

4812

SUDAN III

E

Permitted for use only as a colour for topical use.

 

4813

SUGAR CANE WAX ALCOHOLS

A, H

The maximum recommended daily dose must not provide more than 12mg.

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

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

 

4814

SUGARCANE

E, H

When for oral or sublingual use, sucrose is a mandatory component of sugarcane.

 

4815

SULFATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

 

4816

SULFATED LOW MOLECULAR WEIGHT FUCANS

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 0.025%.

 

4817

SULFUR DIOXIDE

E

 

4818

SULFUR IODIDE

H

Only for use as an active homoeopathic ingredient. 

 

4819

SULFURIC ACID

E, H

Only for use as an active homoeopathic ingredient or excipient ingredient. 

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

 

4820

SULFURISED 1-METHYL-4-(1-METHYLETHENYL)-CYCLOHEXENE

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%.

 

4821

SULISOBENZONE

A

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

The concentration in the medicine must not be more than 10%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

4822

SULISOBENZONE SODIUM

A

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

The concentration in the medicine must not be more than 10%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

4823

SUNFLOWER OIL

A, E, H

 

4824

SUNFLOWER SEED

E, H

 

4825

SUNSET YELLOW FCF

E

Permitted for use only as a colour for either topical use or with an oral route of administration.

 

4826

SUNSET YELLOW FCF ALUMINIUM LAKE

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

4827

SUPEROXIDE DISMUTASE

E

Only for use in topical medicines for dermal application.

 

4828

SWEDE

E

 

4829

SWEET ORANGE 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%.

 

4830

SWEET POTATO

E

 

4831

SWERTIA CHIRATA

A, H

 

4832

SWIETENIA MAHOGANI

A, H

 

4833

SYAGRUS ROMANZOFFIANA

A, E, H

 

4834

SYMPHYOTRICHUM NOVI-BELGII

A, H

 

4835

SYMPHYTUM OFFICINALE

H

When used orally as an active homoeopathic ingredient, the concentration must be a dilution of 12X or more.

When used in topical medicines for dermal application, the concentration in the preparation must be no more than 10mg/kg or 10mg/L or 0.001%.

 

4836

SYMPLOCARPUS FOETIDUS

A, H

 

4837

SYNTHETIC BEESWAX

E

Only for use in topical medicines for dermal applications.

 

4838

SYNTHETIC TERPENE RESIN

E

Only for use in topical, oral or oral application medicines.

When the route of administration is oral, the dosage form must be chewing gum.

 

4839

SYNTHETIC WAX

E

 

4840

SYRINGA RETICULATA

A, H

 

4841

SYRINGA VULGARIS

A, H

 

4842

SYZYGIUM AROMATICUM

A, E, H

When the plant preparation is oil or distillate and the concentration of this oil or distillate in the product is greater than 25%, the nominal capacity of the container must be no more than 25 millilitres and the medicine must include the following warning statements on the medicine label:

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

- (NTAKEN) 'Not to be taken'.

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

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

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

 

4843

SYZYGIUM CUMINI

A, H

 

4844

SYZYGIUM JAMBOS

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 not be more than 0.0693%.

 

4845

TABEBUIA SERRATIFOLIA

A, E, H

 

4846

TAGETES ERECTA

A, E, H

When used as an excipient ingredient, only for use in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must not be more than 5%.

 

4847

TAGETES MINUTA

A, E, H

 

4848

TAGETES 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%.

 

4849

TAIPAN SNAKE

H

Only for use as an active homoeopathic ingredient.

 

4850

TALLOW

E

Only for use in topical medicines for dermal application.

 

4851

TALLOW GLYCERIDES

E

 

4852

TAMARINDUS INDICA

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%.

 

4853

TAMARIX APHYLLA

A, H

 

4854

TAMARIX CHINENSIS

A, H

 

4855

TAMARIX GALLICA

A, H

 

4856

TAMUS COMMUNIS

A, H

If the plant part is fruit or root, the maximum recommended daily dose must be no more than 1mg of the equivalent dry fruit or dry root of Tamus communis.

 

4857

TANACETUM CINERARIIFOLIUM

A, H

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

 

4858

TANACETUM PARTHENIUM

A, E, H

 

4859

TANACETUM VULGARE

A, H

Oil (of Tanacetum vulgare) is a mandatory component of Tanacetum vulgare.

The concentration of oil (of Tanacetum vulgare) in the medicine must be no more than 0.8%.

 

4860

TANGERINE 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%.

 

4861

TANGERINE OIL COLDPRESSED

A, E, H

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

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

 

4862

TANNIC ACID

E

 

4863

TAPIOCA STARCH

E

 

4864

TARAXACUM MONGOLICUM

A, E, H

 

4865

TARAXACUM OFFICINALE

A, E, H

 

4866

TARO

E

 

4867

TARRAGON OIL

A, E, H

 

4868

TARTARIC ACID

E

 

4869

TARTRAZINE

E

Only for use as a colour.

Only for use in medicines for topical and oral administration.

 

4870

TARTRAZINE ALUMINIUM LAKE

E

Only for use as a colour.

Only for use in medicines for topical and oral administration.

 

4871

TASMANNIA LANCEOLATA

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%.

 

4872

TAURINE

A, E

 

4873

TEA-STEARATE

E

Only for use in topical medicines for dermal application.

 

4874

TERMINALIA ARJUNA

A

Only for use in oral medicines.

Only for use when the plant part is bark.

The maximum recommended daily dose must be no more than 6 grams of Terminalia arjuna dried bark or its extract equivalents.

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

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

- (CHILD2) 'Not suitable for children'.

 

4875

TERMINALIA BELLIRICA

A

Only for use when the preparation is as an aqueous extract of the fruit pericarp.

 

4876

TERMINALIA CATAPPA

A, H

 

4877

TERMINALIA CHEBULA

A, H

 

4878

TERMINALIA FERDINANDIANA

A, E, H

Only for use when the plant part is fruit flesh, fruit flesh dry or the preparation is as an aqueous extract of the fruit flesh.

When used as an excipient, the ingredient is only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin or in the eye.

When used as an excipient, the concentration in the medicine must be no more than 0.3%.

 

4879

TERMINALIA SERICEA

E

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

Only for use when the plant part is root bark.

Only methanol/water (90:10; V/V) extract of Terminalia sericea bark of the root is approved.

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

 

4880

TERPENE RESIN

E

Terpene resin must only be included in medicines when in combination with other permitted ingredients as a proprietary excipient formulation in medicines with a dermal route of administration for topical application.

 

4881

TERPINEN-4-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%.

 

4882

TERPINEOL

E

 

4883

TERPINEOL 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%.

 

4884

TERPINOLENE

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%.

 

4885

TERPINYL 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%.

 

4886

TERPINYL BUTYRATE

E

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

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

 

4887

TERPINYL METHYL 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%.

 

4888

TERT-BUTYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

4889

TERT-BUTYL HYDROQUINONE

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%.

 

4890

TERT-BUTYL METHYL 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%.

 

4891

TERT-BUTYLPYRAZINE

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%.

 

4892

TETRACLINIS ARTICULATA

A, E, H

 

4893

TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE

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%.

 

4894

TETRADIUM RUTICARPUM

A, H

When for internal use, oxedrine is a mandatory component of Tetradium ruticarpum.

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

 

4895

TETRAHEXYLDECYL ASCORBATE

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%.

 

4896

TETRAHYDRO LINALYLACETATE

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%.

 

4897

TETRAHYDRO PARA-METHYLQUINOLINE

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%.

 

4898

TETRAHYDRO-6-(3-PENTENYL)-2H-PYRAN-2-ONE

E

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

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

 

4899

TETRAHYDRODIFERULOYLMETHANE

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%.

 

4900

TETRAHYDROFURFURYL 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%.

 

4901

TETRAHYDROGERANYL 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%.

 

4902

TETRAHYDROLINALOOL

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%.

 

4903

TETRAHYDROMUGUOL

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%.

 

4904

TETRAHYDROMYRCENOL

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%.

 

4905

TETRAHYDROXYPROPYL ETHYLENEDIAMINE

E

Only for use in topical medicines for dermal application.

 

4906

TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES

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%.

 

4907

TETRAPANAX PAPYRIFER

A, H

 

4908

TETRASODIUM ETIDRONATE

E

Only for use in topical medicines for dermal application.

 

4909

TETRASODIUM PYROPHOSPHATE

E

 

4910

TEUCRIUM CHAMAEDRYS

A, H

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

 

4911

TEUCRIUM MARUM

A, H

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

 

4912

TEUCRIUM SCORODONIA

A, H

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

 

4913

THAPSIA GARGANICA

A, H

 

4914

THAUMATIN

E

 

4915

THEASPIRANE

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%.

 

4916

THEMEDA TRIANDRA

A, H

 

4917

THEOBROMA CACAO

A, E, H

Caffeine is a mandatory component of Theobroma cacao.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

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

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80 mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

4918

THEOBROMA OIL

A, E, H

 

4919

THIAMINE

A, E

 

4920

THIAMINE HYDROCHLORIDE

A, E

 

4921

THIAMINE NITRATE

A, E

 

4922

THIOCINEOLE

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%.

 

4923

THIOTAURINE

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 0.02%.

 

4924

THLASPI ARVENSE

A, E, H

 

4925

THREONINE

A, E

 

4926

THUJA OCCIDENTALIS

A, H

 

4927

THUJA PLICATA

A, E, H

 

4928

THYME HERB DRY

A, E, H

 

4929

THYME OIL

A, E, H

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

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

 

4930

THYMOL

A, E

When used as an active ingredient, the medicine must be medicated space spray or medicated throat lozenges.

When used as an excipient, only for use in medicated throat lozenges or topical medicines for dermal applications.

 

4931

THYMOL METHYL ETHER

E

Thymol methyl ether must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of the flavour proprietary excipient formulation containing thymol methyl ether must not be more than 5% of the total medicine.

 

4932

THYMUS CAPITATUS

A, E, H

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

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

 

4933

THYMUS GLAND

H

Only for use as an active homoeopathic ingredient. 

 

4934

THYMUS MASTICHINA

A, E, H

When the plant preparation is an oil, and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, a restricted flow insert must be fitted on the container and the medicine requires the following warning statement on the medicine label:- (CHILD) 'Keep out of reach of children' (or words to that effect).

 

4935

THYMUS SERPYLLUM

A, E, H

When the plant preparation is an oil, and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, a restricted flow insert must be fitted on the container and the medicine requires the following warning statement on the medicine label:- (CHILD) 'Keep out of reach of children' (or words to that effect).

 

4936

THYMUS VULGARIS

A, E, H

When the plant preparation is oil or distillate, and the concentration of Thymus vulgaris oil or distillate in the preparation is greater than 50%:

(a) the nominal capacity of the container must not be more than 25 millilitres;

(b) a restricted flow insert must be fitted on the container; and

(c) the following warning statement is required on the medicine label:

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

 

4937

THYMUS VULGARIS MIS

A, E, H

When the plant preparation is an oil or distillate, and the concentration of Thymus vulgaris MIS oil or distillate in the preparation is greater than 50%:

(a) the nominal capacity of the container must not be more than 25 millilitres;

(b) a restricted flow insert must be fitted on the container; and

(c) the following warning statement is required on the label:

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

 

4938

THYMUS ZYGIS

A, H

When the plant preparation is an oil or a distillate, and the concentration of Thymus zygis oil or distillate in the preparation is greater than 50%:

(a) the nominal capacity of the container must not be more than 25 millilitres;

(b) a restricted flow insert must be fitted on the container; and

(c) the following warning statement is required on the label:

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

 

4939

TIGER SNAKE

H

Only for use as an active homoeopathic ingredient.

 

4940

TILACTASE

A

Must be derived from Aspergillus oryzae and comply with the relevant USP monograph.

 

4941

TILIA CORDATA

A, E, H

 

4942

TILIA PLATYPHYLLOS

A, E, H

 

4943

TILIA TOMENTOSA

A, H

 

4944

TILIA X VULGARIS

A, E, H

 

4945

TILIANTOL

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%.

 

4946

TIN

H

Only for use as an active homoeopathic ingredient. 

 

4947

TINOSPORA CORDIFOLIA

A, H

 

4948

TINOSPORA SINENSIS

A, H

 

4949

TITANIUM DIOXIDE

A, E

For use as an active ingredient only in sunscreens for dermal application.

The concentration in sunscreens must be no more than 25%.

For use as an excipient only as a colour and only in medicines limited to oral and topical routes of administration.

Not to be included in medicines intended for use in the eye.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

4950

TOCOCYSTEAMIDE

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 0.01%.

 

4951

TOCOFERSOLAN

E

Only for oral and topical use.

When for oral use, the concentration in the medicine must be no more than 10% w/w.

When used in topical medicines for dermal application, it is not to be included in medicines intended for use in the eye.

When for topical use, the concentration in the medicine must be no more than 0.1%

 

4952

TOCOPHEROL

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%.

 

4953

TOCOPHERYL GLUCOSIDE

E

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

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

 

4954

TOCOPHERYL LINOLEATE

E

Only for use in topical medicines for dermal application.

 

4955

TOCOPHERYL NICOTINATE

E

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

The concentration must not exceed 0.3%.

 

4956

TOLU BALSAM

A, E, H

 

4957

TOLUENE

E

The residual solvent limit for toluene is 8.9 mg per maximum recommended daily dose.

The concentration in the medicine must be no more than 0.089%.

 

4958

TOLYL ALDEHYDE

E

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

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

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

 

4959

TOLYLALDEHYDE GLYCERYLACETAL

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%.

 

4960

TOMATO

E

 

4961

TONKA

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%.

 

4962

TONKA BEAN EXTRACT

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%.

 

4963

TONONE

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%.

 

4964

TOXICODENDRON DIVERSILOBUM

H

Only for use as an active homoeopathic ingredient. 

 

4965

TOXICODENDRON PUBESCENS

H

Only for use as an active homoeopathic ingredient.

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

 

4966

TOXICODENDRON RADICANS

A, H

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

 

4967

TOXICODENDRON SUCCEDANEUM

H

Only for use as an active homoeopathic ingredient. 

 

4968

TRACHELOSPERMUM JASMINOIDES

A, E, H

 

4969

TRACHYSPERMUM AMMI

A, E

Only for use in oral medicines when the plant part is fruit or seed.

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

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

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

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%.

 

4970

TRAGACANTH

A, E

 

4971

TRAMETES VERSICOLOR

A, H

 

4972

TRAMETES VERSICOLOR PROTEOGLYCAN CONCENTRATE

A, H

Only for use in oral medicines.

 

4973

TRANS,TRANS-2,4-DECADIEN-1-AL

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%.

 

4974

TRANS,TRANS-2,4-HEXADIENAL

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 the medicine must be no more than 1%.

The maximum daily dose must provide no more than 13.5 mg of Trans,Trans-2,4-Hexadienal.

 

4975

TRANS-1-(2,4,4-TRIMETHYL-2-CYCLOHEXEN-1-YL)-2-BUTEN-1-ONE

E

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

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

 

4976

TRANS-2-DECENAL

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%.

 

4977

TRANS-2-DODECENAL

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%.

 

4978

TRANS-2-HEPTEN-1-AL

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%.

 

4979

TRANS-2-HEXENAL

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%.

 

4980

TRANS-2-HEXENOIC 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%.

 

4981

TRANS-2-HEXENOL

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%.

 

4982

TRANS-2-HEXENYL 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%.

 

4983

TRANS-2-HEXENYL PHENYLACETATE

E

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

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

 

4984

TRANS-2-HYDROXYCINNAMIC ACID

E

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

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

 

4985

TRANS-2-OCTENAL

E

trans-2-Octenal must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing trans-2-octenal must not be more than 1% of the total medicine.

 

4986

TRANS-2-UNDECENAL

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%.

 

4987

TRANS-3-HEXENOIC 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%.

 

4988

TRANS-4-DECENAL

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%.

 

4989

TRANS-8-(1-METHYLETHYL)-1-OXASPIRO(4.5)DECAN-2-ONE

E

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

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

 

4990

TRANS-ETHYL 2-OCTENOATE

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%.

 

4991

TRANS-METHYL-2-HEXENOATE

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%.

 

4992

TREACLE

E

When for oral or sublingual use, sucrose is a mandatory component of treacle.

 

4993

TREEMOSS ABSOLUTE

E

Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation.

When included in a medicine for use on the lips the concentration of treemoss absolute must be no more than 0.02%.

When for dermal use or use on the hair the concentration of treemoss absolute must be no more than 0.1%

The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

 

4994

TREFRIW WELLS MINERAL WATER

A

When for internal use, iron is a mandatory component of Trefriw Wells mineral water.

Solid dosage forms containing more than 5 milligrams of elemental iron in each dosage unit are required to have a child resistant closure.

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

Only able to be used when presented in single use sachets for therapeutic use as an iron supplement.

 

4995

TREHALOSE DIHYDRATE

E

When for oral use and the quantity of trehalose dihydrate per maximum recommended daily dose exceeds 20 grams, the quantity of trehalose dihydrate must be declared on the label.

 

4996

TREMELLA FUCIFORMIS

A, H

 

4997

TRIACETIN

E

 

4998

TRIACONTANYL PVP

E

Only for use in topical medicines for dermal application.

 

4999

TRIADICA SEBIFERA

A, H

 

5000

TRIBASIC POTASSIUM PHOSPHATE

A, E, H

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

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

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

 

5001

TRIBASIC SODIUM PHOSPHATE

E

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

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

 

5002

TRIBEHENIN

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 6%.

 

5003

TRIBEHENIN PEG-20 ESTERS

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 6%.

 

5004

TRIBULUS TERRESTRIS

A, E, H

 

5005

TRIBUTYL ACETYLCITRATE

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%.

 

5006

TRICALCIUM PHOSPHATE

E

 

5007

TRICAPRYLIN

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%.

 

5008

TRICAPRYLYL 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 7%.

 

5009

TRICETEARETH-4 PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

5010

TRICHLOROMETHYLPHENYLCARBINYL 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%.

 

5011

TRICHODERMA VIRIDE

A, E, H

 

5012

TRICHOSANTHES KIRILOWII

A, E, H

 

5013

TRICLOSAN

E

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

 

5014

TRICYCLODECENYL PROPIONATE

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%.

 

5015

TRIDECANAL

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%.

 

5016

TRIDECETH-4 PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

5017

TRIDECETH-6

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 0.5%.

 

5018

TRIDECYL ALCOHOL

E

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

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

 

5019

TRIDECYL BEHENATE

E

Behenic acid is a mandatory component of Tridecyl behenate.

Only for use in topical medicines for dermal application.

 

5020

TRIDECYL NEOPENTANOATE

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 23%.

 

5021

TRIDECYL SALICYLATE

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%.

 

5022

TRIDECYL STEARATE

E

Only for use in topical medicines for dermal application.

 

5023

TRIDECYL TRIMELLITATE

E

Only for use in topical medicines for dermal application.

 

5024

TRIETHOXYCAPRYLYLSILANE

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 1%.

 

5025

TRIETHYL CITRATE

E

 

5026

TRIETHYLENE GLYCOL

E

 

5027

TRIFOLIUM PRATENSE

A, E, H

 

5028

TRIFOLIUM REPENS

A, H

 

5029

TRIGONELLA FOENUM-GRAECUM

A, E, H

 

5030

TRIHYDROXYPALMITAMIDOHYDROXYPROPYL MYRISTYL ETHER

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 0.02%.

 

5031

TRIHYDROXYSTEARIN

E

Only for use in topical medicines for dermal application.

 

5032

TRIISOCETYL CITRATE

E

Only for use in topical medicines for dermal application.

 

5033

TRIISODECYL TRIMELLITATE

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%.

 

5034

TRIISONONANOIN

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%.

 

5035

TRIISOSTEARIN

E

Only for use in topical medicines for dermal application.

 

5036

TRILAURIN

E

Only for use in topical medicines for dermal application.

 

5037

TRILISA ODORATISSIMA

A, H

 

5038

TRILLIUM ERECTUM

A, H

 

5039

TRIMETHOXYCAPRYLYL SILANE

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 0.25%.

 

5040

TRIMETHYL HYDROXYPENTYL 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%.

 

5041

TRIMETHYL UNDECYLENIC ALDEHYDE

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%.

 

5042

TRIMETHYL-BICYCLO-HEPTANE-SPIROCYCLOHEXENONE

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%.

 

5043

TRIMETHYLBENZENEPROPANOL

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%.

 

5044

TRIMETHYLHEXANOL

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%.

 

5045

TRIMETHYLOPROPANE TRIOCTANOATE

E

Only for use in topical medicines for dermal application.

 

5046

TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER

E

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

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

 

5047

TRIMETHYLSILOXYSILICATE

E

Only for use in topical medicines for dermal application.

 

5048

TRINITROPHENOL

H

Only for use as an active homoeopathic ingredient.

The total concentration of trinitrophenol in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

 

5049

TRIOCTANOIN

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%.

 

5050

TRIOCTYLDODECYL 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 12%.

 

5051

TRIOLEIN

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%.

 

5052

TRIOSTEUM PERFOLIATUM

A, H

 

5053

TRIOXAUNDECANEDIOIC ACID

E

 

5054

TRIPAL

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%.

 

5055

TRIPEPTIDE-1

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%.

 

5056

TRIS-BIPHENYL TRIAZINE

A

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

The concentration in the medicine must not be more than 10%.

When used topically, the dosage form must not be spray.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

5057

TRISILOXANE

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 40%.

 

5058

TRISODIUM EDETATE

E

Only for use in topical medicines for dermal application.

 

5059

TRISODIUM ETHYLENEDIAMINE DISUCCINATE

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 0.2%.

 

5060

TRISODIUM NTA

E

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

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

 

5061

TRISTEARIN

E

 

5062

TRITICUM AESTIVUM

A, E, H

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

 

5063

TRITICUM DURUM

A, E, H

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

 

5064

TRIUNDECANOIN

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 11.2%.

 

5065

TROLAMINE

E

Only for use in topical medicines for dermal application.

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

 

5066

TROLAMINE LAURIL SULFATE

E

Only for use in topical medicines for dermal application.

 

5067

TROLAMINE SALICYLATE

A

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

The concentration in the medicine must not be more than 12%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

5068

TROLLIUS CHINENSIS

A, H

 

5069

TROMETAMOL

E

 

5070

TROMETAMOL HYDROCHLORIDE

E

 

5071

TROPAEOLUM MAJUS

A, E, H

 

5072

TROPICAL RATTLESNAKE

H

Only for use as an active homoeopathic ingredient.

 

5073

TROPOLONE

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 0.01%.

 

5074

TSUGA CANADENSIS

A, H

 

5075

TULIPA EDULIS

A, H

Colchicine is a mandatory component of Tulipa edulis.

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

 

5076

TURMERIC

E

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

 

5077

TURNERA DIFFUSA

A, E, H

Beta-arbutin is a mandatory component of Turnera diffusa.

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

When for dermal application exclusively to the face:

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

b) hydroquinone is a mandatory component; and

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

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

 

5078

TURNIP

E

 

5079

TURPENTINE OIL

A, E

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

 

5080

TYPHA ANGUSTIFOLIA

A, H

 

5081

TYPHA LATIFOLIA

A, H

 

5082

TYPHONIUM GIGANTEUM

A, H

 

5083

TYROSINE

A, E