SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Verruca Treatment Family Health Verruca Treatment Numark Verruca Treatment Tesco Verruca Treatment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Salicylic acid BP 50% w/w

3 PHARMACEUTICAL FORM

Cutaneous paste

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the destruction of plantar warts.

4.2 Posology and method of administration

For external use.

Adults, the elderly and children

Thoroughly cleanse the surrounding area with soap or surgical spirit using cotton wool or a piece of clean material which should be disposed of carefully after use.

Apply a protective ring-pad centrally over the verruca and place a small quantity of the paste into the central hole of the ring. Cover with a plaster and leave in place for 2-3 days. Repeat as necessary using a fresh ring-pad and plaster each time.

4.3 Contraindications

Diabetes.

4.4    Special warnings and precautions for use

•    Discontinue use if painful irritation develops

•    Keep away from the eyes

•    Keep out of the reach of children

•    Wash your hands immediately after use

•    If the verruca does not separate from the surrounding healthy tissue after two weeks, consult your doctor or state registered chiropodist

•    If the ointment comes into contact with healthy skin, or the eyes, flush immediately with cold water

•    Diabetics should only use this product under medical supervision

•    This product is intended for the treatment of small round shaped verrucas, no larger than the protective ring pads. If your verruca is larger than this or is irregular in shape, do not use this product. Instead consult your doctor or state registered chiropodist

4.5    Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

No reason is known why this product may not be used in this condition.

Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

May cause dermatitis. Symptoms of acute systemic salicylate poisoning have been reported after the application of salicylic acid ointments and solution to large areas of the body. This is unlikely to happen when treating plantar warts.

4.9 Overdose

Either from oral consumption of contents of tube or from excessive application:

Empty the stomach (if ingested) and determine the plasma salicylate concentration. If the concentration is less than 350mg/L in children or 450mg/L in adults, simply increase oral fluid intake. If the concentration is higher, treat patient by forced alkaline diuresis.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

A kerolytic agent.

Pharmacokinetic properties

Not applicable.

Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

White soft paraffin BP, liquid paraffin BP.

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months unopened.

6.4 Special precautions for storage

None.

6.5 Nature and contents of container

5g of product contained in a 12.7mm x 88mm internally lacquered collapsible aluminium tube with a 60 eye ointment cap. Packed into a carton with 6 corn rings 1/8” x 17mm CD and 6 self adhesive plasters 5 x 3cm.

Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

AYRTON SAUNDERS LIMITED NORTH WAY

WALWORTH INDUSTRAIL ESTATE

ANDOVER

SP10 5AZ

UNITED KINGDOM

8    MARKETING AUTHORISATION NUMBER(S)

PL 16431/0042

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

3^rd March 1978 / 17^th April 1996

10    DATE OF REVISION OF THE TEXT

29/01/2009

11    DOSIMETRY (IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF

RADIOPHARMACEUTICALS (IF APPLICABLE)