Medicine
Epsolay 3% cream
Epsolay 3% cream is a prescription medicine containing Benzoyl peroxide for topical use, marketed by Mayne Pharma Commercial, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. Store at 20°C to 25°C (68°F to 77°F) with excursions permitted…
Key facts
- Active ingredient (INN)
- Benzoyl peroxide
- Brand
- Epsolay
- Strength
- 3%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 1 bottle
- Marketing authorisation holder
- Mayne Pharma Commercial
- Manufacturer
- Mayne Pharma Commercial
- Origin register
- US FDA, United States
- Storage
- Do not freeze. 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).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D10AE01 Benzoyl peroxide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 August 2025
- Identifiers
- DailyMed set ID 641981e6-460b-44dd-8146-306c47e5367cNDC 51862-772Application NDA214510
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, pump in 1 carton / 30 g in 1 bottle, pump | 51862-772-30 | Mayne Pharma Commercial | 1 August 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| 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 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
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
Read about Benzoyl peroxideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Epsolay prescribing information (Mayne Pharma Commercial) · U.S. National Library of Medicine, DailyMed
Need Epsolay 3% cream for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.