Medicine
Sulfacetamide 100 mg/mL lotion
Sulfacetamide 100 mg/mL lotion is a generic prescription medicine for topical use, made by 2 labelers, 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 20-25°C (68-77°F).
Key facts
- Active ingredient (INN)
- Sulfacetamide
- Brand
- Sold under the generic name
- Strength
- 100 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Packs
- 1 bottle, 118 mL
- Manufacturers
- Oceanside PharmaceuticalsPadagis Israel Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20-25°C (68-77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D10AF06 Sulfacetamide
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 October 2012
- Identifiers
- RxCUI 1006688DailyMed set ID 4fb4d39a-330e-4c84-abbc-3b33b36b206f, 6fa7399b-4ced-492d-b6f6-cf155764087aNDC 45802-896, 68682-010Application ANDA078649, NDA019931
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, plastic in 1 carton / 118 mL in 1 bottle, plastic | 68682-010-04 | Oceanside Pharmaceuticals | 18 December 2015 |
| 118 mL in 1 bottle, plastic | 45802-896-26 | Padagis Israel Pharmaceuticals | 17 October 2012 |
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 21 July 1946 | 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
Alternatives
Other makers and brands of Sulfacetamide 100 mg/mL lotion.
Other strengths and forms of Sulfacetamide
Clinical summary
Sulfacetamide is a sulfonamide antibacterial indicated in the topical treatment of acne vulgaris. It is available as eye drops, lotion and ophthalmic solution for topical use. MedsAcross supplies Sulfacetamide 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 SulfacetamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Klaron prescribing information (Bausch Health) · U.S. National Library of Medicine, DailyMed
Need Sulfacetamide 100 mg/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.