Salactol Collodion

1. Name Of The Medicinal Product

SALACTOL™ COLLODION

2. Qualitative And Quantitative Composition

Salicylic Acid 16.7% w/w; Lactic Acid 16.7% w/w.

3. Pharmaceutical Form

Colourless or pale yellow/brown evaporative collodion paint.

4. Clinical Particulars

4.1 Therapeutic Indications

For the topical treatment of warts, verrucas, corns and calluses.

4.2 Posology And Method Of Administration

For adults, children and the elderly. Salactol should be applied once daily usually at night. It can take up to twelve (12) weeks for resistant lesions to disappear, and it is necessary to persevere with the treatment. Soak the affected site in warm water and pat dry. Gently rub the surface of the wart, verruca, corn or callus with a pumice stone or manicure emery board to remove any hard skin. Using the applicator provided, carefully apply a few drops of Salactol to the lesion, allowing each drop to dry before applying the next one. Take care to localise the application to the affected area. Plantar warts should be covered with an adhesive plaster. Leave for 24 hours. Repeat the procedure daily, after first removing any plaster.

4.3 Contraindications

Not to be used on or near the face, intertriginous or anogenital regions or by diabetics or individuals with impaired peripheral blood circulation. Not to be used on moles, birthmarks, hairy warts or on any other skin lesions for which Salactol is not indicated. Not to be used in cases of sensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep away from the eyes and mucous membranes. The gel should be applied carefully to the wart, verruca, corn or callus only, to avoid possible irritation of surrounding normal skin. Some mild, transient irritation may be expected, but in cases of more severe or persistent pain/irritation, the treatment should be suspended and/or discontinued. See also Section 4.8. Extremely flammable. Avoid spillage. Avoid inhaling vapour. Replace cap tightly after use.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Salactol may be irritant in certain patients, which in rare instances may appear as a temporary blemish on the skin. See also Section 4.4.

4.9 Overdose

Any excessive use of Salactol could cause irritation of the skin. If this occurs, Salactol should be used more sparingly or applied less frequently. Accidental oral ingestion should be treated immediately by gastric lavage with a 2 to 5% aqueous sodium bicarbonate solution. Fluid and electrolyte balance should be monitored and appropriate supportive measures should be provided. Symptoms include headache, nausea, vomiting, diarrhoea and respiratory depression.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The combination of salicylic acid and lactic acid in flexible collodion has been shown to be particularly efficacious in treating warts, verrucas, corns and calluses.

Salicylic acid has bacteriostatic and fungicidal actions as well as keratolytic properties. Its effectiveness for topical treatment of hyperkeratotic skin lesions is based on mild keratolytic action which produces slow and painless destruction of the epithelium. In the treatment of warts, a mild irritant reaction, which may render the virus more prone to immunologic stimulation or response, may add to the mechanical removal of infected cells. Apart from its antiseptic and caustic properties, lactic acid enhances the availability of salicylic acid from the dried collodion.

5.2 Pharmacokinetic Properties

Salactol contains 16.7% salicylic acid and 16.7% lactic acid in flexible collodion. The bioavailability of salicylic acid is reduced as the collodion film dries on the skin due to entrapment of the drug which inhibits release. The addition of lactic acid to salicylic acid collodion provides more efficient release of the salicylic acid, since the non-volatile lactic acid remains in the film, thus permitting continued release of the keratolytic which may otherwise be entrapped within the dried collodion film. Systemic absorption of salicylic acid or lactic acid after application to small circumscribed areas is exceedingly unlikely.

5.3 Preclinical Safety Data

No special information.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Pyroxylin; Colophony; Castor Oil; IMS; Ether.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

10 ml amber glass bottle with plastic cap, incorporating a specially designed spatula for ease of application. This is supplied as an original pack (OP).

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing Authorisation Number(S)

00173/5006R.

9. Date Of First Authorisation/Renewal Of The Authorisation

2 May 2006.

10. Date Of Revision Of The Text

June 2011.