Compound W

1. Name Of The Medicinal Product

Compound W.

2. Qualitative And Quantitative Composition

Salicylic acid Ph Eur 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 common warts and verrucae.

4.2 Posology And Method Of Administration

Adults, the elderly and children over 6 years: Gently rub the hard skin from the surface of the wart with a pumice stone or emery board. Apply to wart one drop at a time with dropper-rod until wart is covered. Allow to dry completely. Avoid surrounding skin. Repeat application daily, with regular washing, for up to twelve weeks.

4.3 Contraindications

Do not use Compound W 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 wart does not dissolve or gets worse, consult a doctor. If in doubt or have diabetes, ask a 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 unchanged in the urine.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Acetone BP; Industrial Methylated Spirits 99% BP; Pyroxyline (Nitrocellulose DHM 10/25) BP; Castor Oil Ph Eur.

6.2 Incompatibilities

None known.

6.3 Shelf Life

48 months.

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 And Other Handling

Not applicable.

7. Marketing Authorisation Holder

SSL International PLC. Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA.

8. Marketing Authorisation Number(S)

PL 17905/0075

9. Date Of First Authorisation/Renewal Of The Authorisation

15/08/2006

10. Date Of Revision Of The Text

15/08/2006