Fixed-dose combination
Adapalene and Benzoyl peroxide is a fixed-dose combination medicine indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. MedsAcross supplies Adapalene and Benzoyl peroxide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Adapalene and Benzoyl Peroxide gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. Adapalene and Benzoyl Peroxide gel, is a combination of adapalene, a retinoid, and benzoyl peroxide and is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.
Source: US FDA prescribing information
Adapalene Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown. Benzoyl peroxide Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects.
Source: US FDA prescribing information
For topical use only. Adapalene and Benzoyl Peroxide gel is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of Adapalene and Benzoyl Peroxide gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Wash hands after application as Adapalene and Benzoyl Peroxide gel may bleach hair or colored fabrics. Avoid the eyes, lips and mucous membranes. For topical use only Adapalene and Benzoyl Peroxide gel is not for oral, ophthalmic or intravaginal use.
Source: US FDA prescribing information
Adapalene and Benzoyl Peroxide gel is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in Adapalene and Benzoyl Peroxide gel.
Source: US FDA prescribing information
Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with the use of benzoyl peroxide products. Photosensitivity: Avoid exposure to sunlight and sunlamps. Wear broad spectrum sunscreen and protective clothing when sun exposure cannot be avoided. Skin Irritation: Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of Adapalene and Benzoyl Peroxide gel and may necessitate discontinuation.
Source: US FDA prescribing information
Most commonly reported adverse reactions (≥1%) in patients treated with Adapalene and Benzoyl Peroxide gel were skin irritation, eczema, atopic dermatitis, and skin burning sensation.
Source: US FDA prescribing information
Storage and handling Store at controlled room temperature 20 – 25˚C (68 – 77˚F) with excursions permitted to 15˚ – 30˚C (59˚ – 86˚F). Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Adapalene and Benzoyl peroxide, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Adapalene and Benzoyl peroxide 3 mg/25 mg per g gelTopicalGeneric name | Adapalene and Benzoyl peroxide | — | US FDA | Available on request |
| Adapalene and Benzoyl peroxide 1 mg/25 mg per g gelTopicalGeneric name | Adapalene and Benzoyl peroxide | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 8 December 2008 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 2 presentations of Adapalene and Benzoyl peroxide and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Adapalene and Benzoyl peroxide on 8 December 2008, according to Drugs@FDA.
No listed presentation of Adapalene and Benzoyl peroxide is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.