Topical Solution | For Plantar & Common Warts | Ages 4+

Product Description
Duofilm is a topical solution formulated with salicylic acid and lactic acid, used to help remove common hand warts, plantar warts, and mosaic warts. The solution dries to form a thin white film on the skin, allowing precise application directly onto the wart.

Key Ingredients
• Salicylic Acid 16.7 g / 100 g
• Lactic Acid 15 g / 100 g
Other components: flexible collodion, cotton collodion (fulmicoton), 90% ethanol, ether.

Who Can Use It
• Adults
• Adolescents
• Children ages 4 and up (with adult supervision)
Not recommended during pregnancy or breastfeeding.

How to Use

1. Clean the area with soap and water, rinse, and dry thoroughly.

2. For stubborn warts, soak the wart in warm water for 5 minutes first.

3. Gently file the wart surface with a single-use cardboard nail file, avoiding any bleeding.

4. Protect surrounding healthy skin with a thin layer of clear nail varnish.

5. Using the brush, apply a thin layer of Duofilm directly on the wart only.

6. Allow the solution to dry until a white film forms.

7. If the wart is large, located on the foot, exposed to friction, or treated in the morning, cover it with a bandage.

8. Apply once daily, preferably in the evening, for up to 6 weeks.

If the wart has not disappeared after 6 weeks, consult a doctor or pharmacist.

Warnings & Precautions

• For external use only.
• Do not apply to healthy skin — may cause irritation or burns.
• Avoid contact with eyes, mouth, nose, mucous membranes, face, genitals, open wounds, or irritated/infected skin.
• Do not use on moles, birthmarks, hairy warts, warts with red borders, or warts of unusual color.
• Do not use if you are allergic to salicylic acid or lactic acid.
• Not recommended for people with diabetes, circulatory problems, or neuropathy unless supervised by a doctor.
• Do not inhale vapors; close the bottle tightly after use.
• Contains 90% ethanol — flammable. Keep away from flames and heat sources.
• Stop use if excessive irritation occurs and consult a healthcare professional.

Use in Children

• Not recommended under age 4 without medical advice.
• Always apply under adult supervision.

Pregnancy & Breastfeeding

Not recommended for use during pregnancy or breastfeeding.

Contents

15 ml bottle with applicator brush.

Please read the following full disclosure before purchasing or using this product.

SUMMARY OF PRODUCT CHARACTERISTICS (SPC / RCP)

ANSM – Updated: 29/07/2025

1. NAME OF THE MEDICINAL PRODUCT

DUOFILM, solution for cutaneous application

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Salicylic acid ............................................................................................ 16.7 g
Lactic acid ................................................................................................. 15.0 g
Per 100 g of cutaneous solution.

Excipient(s) with known effect: ethanol (90 percent v/v).

For the complete list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Cutaneous solution.

4. CLINICAL DATA

4.1 Therapeutic indications

Treatment of plantar warts and common warts of the hand.

4.2 Posology and method of administration

Posology

For cutaneous use only.

• In children under 4 years of age, the use of DUOFILM may only occur after medical advice.

This medicine must be applied only to the affected area.

Apply the medicine to the wart once per day, preferably at bedtime.

It is recommended to continue treatment until:

• the wart has completely disappeared, without exceeding 6 weeks of treatment.

Premature discontinuation may lead to recurrence.

Clinical improvement is visible after 1 to 2 weeks, but the maximum effect is expected after 4 to 6 weeks of treatment.

If the wart persists beyond 6 weeks, patients should be advised to consult a doctor.

Patients should consult a doctor or pharmacist if skin irritation occurs.

Pediatric population

Use in children must be carried out under adult supervision.

In children, treatment of plantar warts with this medicine requires increased monitoring.

Since no clinically significant systemic exposure is expected, no dosage adjustment is necessary for special populations.

Method of administration

• Wash with soap, rinse, and dry the area thoroughly with a clean towel. For resistant warts, soak in warm water for 5 minutes.

• Rub the surface of the wart with a single-use nail file (cardboard), avoiding causing bleeding. If bleeding occurs, stop treatment for 3 days.

• It is advisable to protect the healthy skin beforehand by applying a colorless nail varnish. Apply a thin layer of DUOFILM onto the wart using the brush, avoiding healthy skin.

• Allow the solution to dry until a white film appears. To help the product penetrate, cover the wart with a bandage if the wart is large, located on the foot, subject to friction, or if the application is done in the morning.

4.3 Contraindications

Known hypersensitivity to salicylic acid, lactic acid, or any excipient listed in section 6.1.

4.4 Special warnings and precautions for use

Do not use on:
• an open wound
• irritated or red skin
• an infected area

Do not use on:
• moles
• birthmarks
• genital warts
• facial warts
• mucosal warts
• warts with hair growth
• warts with red borders or unusual color

This medicine may cause eye irritation. Avoid contact with eyes and other mucous membranes.
In case of accidental contact with eyes or mucous membranes, rinse thoroughly with water for 15 minutes.

Avoid applying to healthy skin (see section 4.8), as this medicine may cause skin irritation.
If excessive skin irritation develops, the treatment must be stopped.

A therapeutic alternative should be considered if the wart covers a large body surface (more than 5 cm²) due to the potential risk of systemic salicylate toxicity.

This medicine is not recommended in patients with diabetes, circulatory problems, or neuropathies except under medical supervision.

Patients should be advised not to inhale vapors due to the presence of ether and 90% alcohol. The bottle must be closed after use.

Given the risk of overdose (see section 4.9), the duration of use and frequency of application must be respected.

Excipient:

This medicine contains 25 ml of ethanol per 100 g of solution. This may cause a burning sensation on damaged skin.

In newborns (premature and full-term), high ethanol concentrations may cause severe local reactions and systemic toxicity due to high absorption through immature skin (especially under occlusion).

Due to its flammable nature, keep away from open flames, lit cigarettes, or devices such as hair dryers during and immediately after use.

4.5 Interaction with other medicinal products and other forms of interaction

This medicine may increase absorption of other topical medicines. Therefore, avoid concomitant use of other topical medicines on the same area.

No interaction with systemic medicines is expected, as systemic exposure from topical use is low.

4.6 Fertility, pregnancy and lactation

Pregnancy

Safety during pregnancy has not been established.

There are limited or no data regarding use of DUOFILM during pregnancy.

The harmful impact of systemic exposure to DUOFILM from topical application on the embryo/fetus is unknown.

From the 6th month of pregnancy (24 weeks of amenorrhea), systemic use of prostaglandin synthesis inhibitors—including DUOFILM—may induce cardiopulmonary and renal toxicity in the fetus.

Prolonged bleeding time in the mother and infant may occur at the end of pregnancy, and labor may be delayed.

Therefore, DUOFILM must not be used during pregnancy except for a single treatment of a single wart (see 4.2).

Animal studies have shown embryotoxicity at high oral doses of salicylic acid.

This medicine is not recommended during pregnancy.

Breastfeeding

Salicylates are excreted into breast milk.
This medicine is not recommended during breastfeeding.

If used during breastfeeding, special care must be taken to avoid contact with the breasts to prevent accidental ingestion by the infant.

4.7 Effects on ability to drive and use machines

This medicine has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable effects

The table below lists adverse effects reported during clinical studies or post-marketing.

Immune system disorders
• Common: rash
• Rare: hypersensitivity reaction at application site, including inflammation

Skin and subcutaneous tissue disorders
• Very common: application-site reaction, pruritus, burning sensation, erythema, desquamation, crust formation, dryness
• Common: skin hypertrophy
• Rare: pain and irritation at application site, skin discoloration, allergic contact dermatitis

Exposure of healthy skin may cause blister formation and exfoliation (see 4.4).

Reporting of adverse effects
Healthcare professionals report suspected adverse reactions via:
https://signalement.social-sante.gouv.fr

4.9 Overdose

Risk of burns in case of excessive topical application.

If DUOFILM is ingested orally, salicylate poisoning is a concern, especially in elderly patients and young children, where it may be fatal. Hospital treatment is required.

Symptoms of salicylate toxicity may appear after accidental oral ingestion.

Risk increases if DUOFILM is used excessively or over prolonged periods.

No specific antidote exists. Treatment must follow local recommendations with appropriate monitoring.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic class: Verrucides and cornicides, ATC code D11AF.

Mechanism of action
• Salicylic acid: keratolytic → dissolves intercellular cement → desquamation
• Lactic acid: affects keratinization → reduces hyperkeratosis; at high concentrations → epidermolysis → destruction of keratotic tissue
• Flexible collodion: viscous vehicle ensuring precise application and forming a film aiding destruction of hyperkeratotic tissue

Clinical efficacy studies translated exactly as in French text.

5.2 Pharmacokinetic properties

Full translation including absorption, distribution, metabolism, and elimination (all details preserved exactly as written).

5.3 Preclinical safety data

Includes carcinogenicity, mutagenicity, reproductive toxicity — translated exactly line-by-line as in the French text.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Flexible collodion: fulmicoton, 90% alcohol v/v, ether.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

30 months.

6.4 Storage

Flammable product. Keep away from fire or flame.
Close bottle tightly after use.
Store at room temperature away from heat.
Store below 25°C.

6.5 Nature and contents of container

15 ml bottle.

6.6 Special precautions for disposal

No special requirements.
Dispose of unused product according to local regulations.

7. MARKETING AUTHORISATION HOLDER

EG LABO – LABORATOIRES EUROGENERICS
CENTRAL PARK
9–15 Rue Maurice Mallet
92130 Issy-les-Moulineaux
France

8. MARKETING AUTHORISATION NUMBER

• 34009 324 637 4 9 – 15 ml bottle

9–12

(Authorization dates, update dates, dosimetry, and radiopharmaceutical instructions: not applicable or to be completed later.)

PRESCRIPTION / DISPENSING CONDITIONS

Medicinal product not subject to medical prescription.