Medicine
Pramosone 10 mg/10 mg per mL lotion
Pramosone 10 mg/10 mg per mL lotion is a prescription medicine containing Hydrocortisone and Pramoxine for topical use, marketed by Legacy Pharma, 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
Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
Key facts
- Active ingredient (INN)
- Hydrocortisone and Pramoxine
- Brand
- Pramosone
- Strength
- 10 mg/10 mg per mL
- Dosage form
- Lotion
- Route
- Topical
- Packs
- 118 mL
- Marketing authorisation holder
- Legacy Pharma
- Manufacturers
- Legacy PharmaSebela Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 July 2015
- Identifiers
- RxCUI 1234393, 1234396DailyMed set ID f207bdff-2f41-4eee-818e-198b6462863e, ce3dd32c-1262-454e-aacb-880d54596dd3NDC 54766-729, 83107-022Application ANDA085980
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 |
|---|---|---|---|
| 118 mL in 1 bottle | 83107-022-04 | Legacy Pharma | 6 June 2025 |
| 118 mL in 1 bottle | 54766-729-04 | Sebela Pharmaceuticals | 2 July 2015 |
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 | Approved | 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
Other strengths and forms of Hydrocortisone and Pramoxine
Clinical summary
Hydrocortisone and Pramoxine is a fixed-dose combination medicine indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It is available as cream, lotion and foam for topical use. MedsAcross supplies Hydrocortisone and Pramoxine 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 Hydrocortisone and PramoxineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Analpram HC prescribing information (Legacy Pharma) · U.S. National Library of Medicine, DailyMed
Need Pramosone 10 mg/10 mg per mL lotion 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.