Medicine
Klaron 100 mg/mL lotion
Klaron 100 mg/mL lotion is a prescription medicine containing Sulfacetamide for topical use, marketed by Bausch Health, 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° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Sulfacetamide
- Brand
- Klaron
- Strength
- 100 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Packs
- 1 bottle
- Marketing authorisation holder
- Bausch Health
- Manufacturer
- Bausch Health
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 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
- 23 December 1996
- Identifiers
- RxCUI 1006688, 1006693DailyMed set ID 66ab38ea-5cea-47be-97f2-486517999fb0NDC 0187-5198Application 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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, plastic in 1 carton / 118 mL in 1 bottle, plastic | 0187-5198-04 | Bausch Health | 23 December 1996 |
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 Klaron 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.