Sodium sulfacetamide
Sodium sulfacetamide is an FDA drug label for the active ingredient SODIUM SULFACETAMIDE manufactured by Oceanside Pharmaceuticals administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20190531.
- Generic name
- SODIUM SULFACETAMIDE
- Manufacturer
- Oceanside Pharmaceuticals
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 68682-010
- Application
- NDA019931
- Label effective
- 20190531
Indications & Usage
INDICATIONS Sodium Sulfacetamide Lotion is indicated in the topical treatment of acne vulgaris .
Dosage & Administration
DOSAGE AND ADMINISTRATION Apply a thin film to affected areas twice daily.
Contraindications
CONTRAINDICATIONS Sodium Sulfacetamide Lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS ).
Warnings
WARNINGS 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 (see ADVERSE REACTIONS ). Sodium Sulfacetamide 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. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people (see CONTRAINDICATIONS ).
Adverse Reactions
ADVERSE REACTIONS In controlled clinical trials for the management of acne vulgaris , the occurrence of adverse reactions associated with the use of Sodium Sulfacetamide 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 Sodium Sulfacetamide 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. To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.