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Compound V

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Compound V.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Salicylic acid 17.0%w/w.

3 PHARMACEUTICAL FORM

Viscous, faintly yellow liquid for topical administration.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment of verruca (plantar warts).

4.2 Posology and method of administration

All sufferers:

Apply to verruca one drop at a time with dropper-rod until verruca is covered. Allow to dry completely.

Avoid surrounding skin.

Repeat application daily with regular washing, for up to twelve weeks.

If condition persists, consult your doctor.

4.3 Contraindications

Do not use Compound V on moles, birth marks, hairy, genital or facial warts.

4.4 Special warnings and precautions for use

Do not apply to healthy skin or skin which is inflamed or broken.

If the verruca does not dissolve or gets worse, consult your doctor. If in doubt or have diabetes ask your doctor.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Pregnancy and lactation

No contraindications known.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

None known.

4.9 Overdose

None probable.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Salicylic acid facilitates desquamation by solubilising the intercellular cement that binds scales in the stratum corneum, thereby loosening the keratin.

5.2 Pharmacokinetic properties

Salicylic acid can be absorbed through the skin. It is excreted as salicyluric acid, phenolic glucuronides and as unchanged salicylic acid.

5.3 Preclinical safety data

The active ingredient in Compound V has a well documented safety record.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Acetone

Industrial methylated spirits 99% Pyroxylin (nitrocellulose DHM 10/25) Castor oil.

6.2 Incompatibilities

None known.

6.3 Shelf life

48 months unopened.

6.4 Special precautions for storage

No special precautions required

6.5 Nature and contents of container

Glass bottle with screw threaded plastic cap and plastic rod wad. Pack size 6.5ml.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Ayrton Saunders Limited,

North Way,

Walworth Industrial Estate,

Andover,

SP10 5AZ United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 16431/0115

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01/03/1999.

10 DATE OF REVISION OF THE TEXT

05/02/2008