SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Corn Solvent

Boots Corn Paint and Pads

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Salicylic acid BP 12.5% w/v

3 PHARMACEUTICAL FORM

External liquid

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

To soften corns for easy removal

4.2 Posology and method of administration

External use only

Adults, the elderly and children:

Apply liberally to top and side of corn. Apply once or twice daily for 4 to 7 nights then soak foot in warm water and lift out the corn with a nail file or something similar.

4.3 Contraindications

Sensitivity to salicylic acid

4.4 Special warnings and precautions for use

To be used with care on large areas of skin. Diabetics should consult their doctor about foot problems. Corn Solvent should be washed off normal skin immediately. Highly inflammable, do not use near fire or flame.

Replace cap securely after use and store below 25⁰C away from heat. For external use only.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Pregnancy and lactation

No known contraindications. However, as with all medicines, use with caution.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

May cause dermatitis. Application to large areas may produce symptoms of acute systemic poisoning.

4.9 Overdose

The quantity of salicylic acid per bottle is below the maximum dose and therefore should give no symptoms of overdosage. However, Corn Solvent does contain acetone which could give rise to symptoms of solvent abuse, treatment consists of removing the patient to fresh air and assisting respiration if necessary.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Salicylic acid has kerolytic properties. Externally, it produces slow and painless destruction of the epithelium when applied in the form of a paint in a collodian base.

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Amyl acetate, pyroxylin 65% w/w. acetone

6.2 Incompatibilities

Incompatible with iodine, iron salts and oxidising substances

6.3 Shelf life

36 months unopened.

6.4 Special precautions for storage

Store below 25 °C

6.6 Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Ayrton Saunders Ltd 9 Arkwright Road Astmoor Industrial Estate Runcorn

Cheshire WA7 1NU

8    MARKETING AUTHORISATION NUMBER(S)

PL 16431/0061

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

12/3/1990 / 24/5/1996

10 DATE OF REVISION OF THE TEXT

05/03/2011