Uses
EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults.
Source: US FDA prescribing information
- Presentations
- 1
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Benzoyl peroxide is a prescription medicine indicated for the treatment of inflammatory lesions of rosacea in adults. It is available as cream for topical use. MedsAcross supplies 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
Key facts
- ATC classification
- D10AE01 Benzoyl peroxide · Acne treatments, subgroup D10A, subgroup D10AE
- US FDA first approval
- 22 April 2022
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Topical
- Dosage forms
- Cream
- Identifiers
- UNII W9WZN9A0GMRxCUI 1418CAS 94-36-0DrugBank DB09096Q411424
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects but the precise mechanism of action in the treatment of rosacea is unknown.
Source: US FDA prescribing information
Dosing overview
Before initial use, prime the pump until the first drop of cream is released. Apply a pea-sized amount of EPSOLAY once daily in a thin layer to each area of the face (forehead, chin, nose, each cheek) on clean and dry skin. Avoid the eyes, lips and mouth. Wash hands after application. EPSOLAY may bleach hair or colored fabric. EPSOLAY is for topical use only. Not for oral, ophthalmic, or intravaginal use. Discard unused EPSOLAY 60 days after first use. Apply to the affected areas once daily.
Source: US FDA prescribing information
Contraindications
EPSOLAY is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in EPSOLAY. A history of a serious hypersensitivity reactions to benzoyl peroxide or any component of the formulation in EPSOLAY.
Source: US FDA prescribing information
Warnings and precautions
Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with the use of benzoyl peroxide products. Skin irritation/contact dermatitis: Erythema, scaling, dryness, stinging/burning, irritation and allergic contact dermatitis may occur with use of EPSOLAY and may necessitate discontinuation. Photosensitivity: Avoid or minimize exposure to natural or artificial sunlight and use sun protection measures.
Source: US FDA prescribing information
Side effects
Most common adverse reactions (incidence ≥ 1%) are application site reactions: pain, erythema, pruritis and edema.
Source: US FDA prescribing information
Storage
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
1 presentations of Benzoyl peroxide, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Epsolay 3% creamTopical | Mayne Pharma Commercial | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
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 22 April 2022 | 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 |
Conditions
Conditions linked to Benzoyl peroxide in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Benzoyl peroxide available for export from India?
Yes, on request. MedsAcross lists 1 presentations of Benzoyl peroxide and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Benzoyl peroxide have?
The catalogue lists 1 brand names for Benzoyl peroxide, including Epsolay.
Is Benzoyl peroxide approved by the US FDA?
Yes. The US FDA first approved Benzoyl peroxide on 22 April 2022, according to Drugs@FDA.
Does Benzoyl peroxide need cold chain shipping?
No listed presentation of Benzoyl peroxide is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Benzoyl peroxide in?
Benzoyl peroxide is classified under ATC code D10AE01 (Benzoyl peroxide).
References
- Epsolay prescribing information (Mayne Pharma Commercial). U.S. National Library of Medicine, DailyMed. Retrieved 11 August 2025
Request Benzoyl peroxide for export supply
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