Occlusal.

26% w/w cutaneous solution

Salicylic Acid 26% w/w.

For excipients, see 6.1

Cutaneous solution

A colourless to pale yellow solution with a characteristic smell of nail varnish

Occlusal is indicated for the treatment and removal of common and plantar warts (verrucae).

For topical application.

Prior to application soak wart in warm water for five minutes. Remove loose tissue with a brush, emery board, pumice or abrasive sponge, being careful to avoid causing pin-point bleeding or abrading the surrounding healthy skin. Dry thoroughly with a towel not used by others to avoid contagion. Carefully apply Occlusal twice to the wart using the brush applicator allowing the first application to dry before applying the second. Thereafter repeat treatment once daily or as directed by physician. Do not apply to surrounding healthy skin. Clinically visible improvement should occur in one to two weeks but maximum effect may be expected after four to six weeks.

There are no differences in dosage for children, adults or the elderly.

Occlusal should not be used by diabetics or patients with impaired blood circulation. Do not use on moles, birthmarks, unusual warts with hair growth, on facial warts, or in the anal or perineal region.

Occlusal is for external use only. Do not permit contact with eyes or mucous membranes. If contact occurs flush with water for 15 minutes. Do not allow contact with normal skin around wart. Avoid using on areas of broken or damaged skin. Discontinue treatment if excessive irritation occurs.

None known.

The chronic use of this product during pregnancy and lactation, particularly when large areas of skin are involved, should be avoided.

None known.

A localised irritant reaction may occur if Occlusal is applied to normal skin surrounding the wart. This may normally be controlled by temporarily discontinuing the use of Occlusal and by being careful to apply the solution only to the wart itself when treatment is resumed.

Salicylism can occur following large doses of salicylic acid or prolonged use of topical salicylic preparations, or in the unlikely event of accidental consumption.

Salicylic acid has bacteriostatic and fungicidal actions, but it is its keratolytic properties which are important for this medicinal product. When applied externally it produces slow and painless destruction of the epithelium. Salicylic acid is usually applied in the form of a paint in a collodian base (10 to 17%) or as a plaster (20 to 50%) to destroy warts or corns.

Not applicable.

None presented.

Polyvinyl butyral

Dibutyl phthalate

Isopropyl alcohol

Butyl acetate

Acrylates copolymer

Not applicable

2 years.

Do not store above 25°C

The product is presented in a 10ml amber glass bottle with cap brush assembly. The cap brush assembly comprises of a black cap and a white polythene wand nylon brush with stainless steel staple.

Occlusal is flammable and should be kept away from flame or fire. Keep the bottle tightly capped when not in use. Do not allow the solution to drip from the brush onto the bottle neck thread, otherwise subsequent opening of the bottle may be difficult.

Alliance Pharmaceuticals Limited

Avonbridge House

2 Bath Road

Chippenham

Wiltshire, SN15 2BB

UK

PL 16853/0071

7^th September 1998/18^th May 2005

May 2005