Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SALICYLIC ACID LACTIC ACID
GlaxoSmithKline (Ireland) Limited
16.7/16.7 %w/w
Cutaneous Suspension
2010-12-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DUOFILM Cutaneous Solution Salicylic Acid 16.7% w/w Lactic Acid 16.7% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Salicylic Acid 16.7 % w/w Lactic Acid 16.7 % w/w For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous Solution. Yellow to amber coloured, slightly viscous clear liquid having an ether odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DUOFILM is indicated in the treatment of warts. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DUOFILM should be applied to warts once daily. Children under 12 years should only use the product under supervision. Treatment of infants under the age of 2 years is not recommended. The patient should be instructed as follows. Soak the warts in warm water for 5 minutes. Rub surface of warts carefully with pumice stone or emery board. Apply, taking care to avoid normal skin. Allow to dry thoroughly. Continue treatment until the wart is completely cleared. If warts persist beyond 12 weeks of treatment, the patient should be advised to consult their doctor. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients. Do not use on open skin wounds, moles, birthmarks, genital warts, warts on the face, or warts with hair growing from them, red edges, or unusual colour. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This medicinal product is for external use only. Avoid getting the product in the eyes, nose, or mouth, or on the genital and anal areas. If contact with the eyes occurs, flush with water for 15 minutes. Avoid inhaling vapour. Ensure this product is stored out of the reach of children to avoid accidental ingestion. Consider alternative treatments if warts cover a large area of the body (more t Read the complete document