Uses
Klaron Lotion is indicated in the topical treatment of acne vulgaris.
Source: US FDA prescribing information
- Presentations
- 4
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
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
Key facts
- Pharmacological class
- Sulfonamide Antibacterial
- ATC classification
- D10AF06 Sulfacetamide · Acne treatments, subgroup D10A, subgroup D10AFS01AB04 Sulfacetamide · Eye medicines, subgroup S01A, subgroup S01AB
- US FDA first approval
- 21 July 1946
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Ophthalmic, Topical
- Dosage forms
- Eye drops, Lotion, Ophthalmic solution
- Identifiers
- UNII 4965G3J0F5RxCUI 10169CAS 144-80-9DrugBank DB00634Q2022983
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours. The pharmacokinetics of sulfacetamide and its major metabolite sulfaniliamide in Klaron Lotion was evaluated in adult subjects (N=14) with acne vulgaris. The subjects applied Klaron Lotion to their face, back, chest, and shoulders every 12 hours for 28 days.
Source: US FDA prescribing information
Dosing overview
Apply a thin film to affected areas twice daily.
Source: US FDA prescribing information
Contraindications
Klaron Lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation.
Source: US FDA prescribing information
Warnings and precautions
Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash, or other reactions, discontinue use of this preparation. Klaron Lotion contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.
Source: US FDA prescribing information
Side effects
In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of Klaron Lotion was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with Klaron Lotion had adverse reactions of erythema, itching, and edema. It has been reported that sodium sulfacetamide may cause local irritation, stinging, and burning. While the irritation may be transient, occasionally the use of medication has to be discontinued.
Source: US FDA prescribing information
Storage
Store at 20° to 25°C (68° to 77°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
4 presentations of Sulfacetamide, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Sulfacetamide 100 mg/mL eye dropsOphthalmicGeneric name | — | US FDA | Available on request |
| Sulfacetamide 100 mg/mL lotionTopicalGeneric name | — | US FDA | Available on request |
| Klaron 100 mg/mL lotionTopical | Bausch Health | US FDA | Available on request |
| Sulfacetamide 100 mg/mL ophthalmic solutionOphthalmicGeneric name | — | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| 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 |
Conditions
Conditions linked to Sulfacetamide in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Sulfacetamide available for export from India?
Yes, on request. MedsAcross lists 4 presentations of Sulfacetamide and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Sulfacetamide have?
The catalogue lists 1 brand names for Sulfacetamide, including Klaron.
Is Sulfacetamide approved by the US FDA?
Yes. The US FDA first approved Sulfacetamide on 21 July 1946, according to Drugs@FDA.
Does Sulfacetamide need cold chain shipping?
No listed presentation of Sulfacetamide is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Sulfacetamide in?
Sulfacetamide is classified under ATC code D10AF06 (Sulfacetamide).
References
- Klaron prescribing information (Bausch Health). U.S. National Library of Medicine, DailyMed. Retrieved 31 August 2020
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