Duofilm Topical Solution

Salicylic acid is a widely used and effective keratolytic, it produces desquamation and destruction of the epithelium by solubilising the intercellular cement of the Stratum Corneum. Lactic acid affects the keratinisation process, reducing hyperkeratosis and is also caustic, leading to the destruction of hyperkeratotic tissue. Collodion is derived from cellulose in a base containing ethanol and ether. It allows easy and accurate application of the product and dries to leave a film which hydrates the tissue and facilitates penetration of the active ingredients.

Unscrew bottle cap and with the help of brush applicator, apply to the affected areas. ‘Before starting to use this topical solution, unscrew the fitted cap, discard it. Carefully remove the plug away from your body to avoid splashing into eyes/ face and discard it, replace with the brush applicator cap provided in
the sealed polybag given in the carton. This topical solution should be applied to the affected areas once daily, according to the following instructions:

1. Soak affected site in hot water for five minutes.
2. Rub surface carefully with pumice stone or emeryboard to remove any hard skin. Dry with your own towel.
3. Apply this topical solution using the brush applicator supplied, taking care to avoid contact with normal skin.
4. Allow to dry thoroughly and cover with plaster if lesion is large or on the foot to help penetration of active ingredients.
5. Continue treatment once daily until the lesion is completely cleared and the ridge lines of the skin have been restored or when the corn can be removed.
6. The usual treatment period is 6 to 12 weeks.

This topical solution may increase the absorption of other topically applied medicines. Therefore, concomitant use of this topical solution and other topical medicines on the treated area should be avoided. As systemic exposure of topically applied this topical solution is low, interaction with systemically administered medicines is not anticipated.

Hypersensitivity to the active substances or to any of the excipients. Do not use on open wounds, irritated or reddened skin, or any area that is infected. This solution should not be used on the face, anogenital regions, moles, birthmarks, mucous membranes, warts with hair growing from them, red edges or an unusual colour. Avoid applying to normal skin. This solution may cause eye irritation. Avoid contact with eyes and other mucous membranes. In case of accidental contact with the eyes or other mucous membranes, flush with water for 15 minutes. Avoid exposure to healthy skin. This solution may cause skin irritation. If undue skin irritation develops treatment should be discontinued. Consider alternative treatments if warts cover a large area of the body (more than 5 cm2) due to the potential risk of salicylate toxicity. This solution is not recommended in patients with diabetes, circulatory problems or peripheral neuropathy except under the supervision of a doctor. Oral salicylates taken during or immediately after a viral illness have been associated with Reye’s syndrome and hence there is a theoretical risk with topical salicylates. Therefore, use is not advised in children or teenagers during or immediately after chickenpox, influenza, or other viral infections. It has been reported that salicylates are excreted via breastmilk. Patients should be advised not to inhale the vapour. Keep out of the sight and reach of children.

Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated reports.

Rash (common), Skin and subcutaneous tissue disorders: Application site reaction, pruritus, burning sensation, erythema, scaling, dryness (Very common), Skin hypertrophy (Common).

Toxicities: In the event of accidental oral ingestion symptoms of salicylate toxicity may occur. The risk of developing symptoms of salicylate poisoning or salicylism is increased if this solution is used excessively or if it is used for prolonged periods of time. Therefore, duration of use and recommended frequency compliance is very important. Management should be as clinically indicated.

The safety of this solution during human pregnancy has not been established. Studies in animals given salicylic acid orally demonstrated embryo toxicity at high doses. D-film is not recommended during pregnancy. Salicylates are excreted in human milk. This solution is not recommended during lactation. If used or administered during lactation, care should be taken to avoid contact with the breast area in order to avoid accidental ingestion by the infant.

Duofilm is formulated for the controlled corrosion of keratin and thus care should be taken to apply the product to the affected area only. Do not use on the face or anogenital regions or if you are diabetic or have impaired circulation. Do not use on moles, birthmarks or unusual skin growths. Do not treat warts over large areas at one time, or use on infants and very young children unless on medical advice. For External Use Only

Excessive topical use may result in burning, particularly of normal skin. Following excessive topical use, apply emollients as required. Following ingestion, administer copious quantities of water and antacids as required. Ingestion may cause nausea, vomiting and abdominal pain.

Combined preparations

In view of its high inflammability, it is recommended that Salicylic Acid & Lactic Acid be stored in a cool place not exceeding 25°C. Keep away from naked flame. Keep out of reach of children. Since this topical solution is volatile, close the bottle tightly after each use.