Medicine
Twyneo 30 mg/1 mg per g cream
Twyneo 30 mg/1 mg per g cream is a prescription medicine containing Benzoyl peroxide and Tretinoin 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store TWYNEO between 2°C to 8°C (36°F to 46°F) until dispensed to the patient…
Key facts
- Active ingredient (INN)
- Benzoyl peroxide and Tretinoin
- Brand
- Twyneo
- Strength
- 30 mg/1 mg per g
- 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
- Store TWYNEO between 2°C to 8°C (36°F to 46°F) until dispensed to the patient. Do not freeze. After Dispensing: Store TWYNEO at room temperature between 20°C to 25°C (68°F to 77°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 August 2025
- Identifiers
- RxCUI 2565807, 2565812DailyMed set ID 654ae869-5bc0-40b3-a423-dcc3270c05d8NDC 51862-771Application NDA214902
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 | 51862-771-30 | 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 26 July 2021 | 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 and Tretinoin is a fixed-dose combination medicine indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. MedsAcross supplies Benzoyl peroxide and Tretinoin 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 peroxide and TretinoinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Twyneo prescribing information (Mayne Pharma Commercial) · U.S. National Library of Medicine, DailyMed
Need Twyneo 30 mg/1 mg per g 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.