Sodium sulfacetamide

FDA Drug Profile — Sodium sulfacetamide

Sodium sulfacetamide is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Sodium sulfacetamide. Available dosage form: lotion.

Drug Details

Generic Name
Sodium sulfacetamide
Brand Names
Sodium sulfacetamide
Application Number
NDA019931
Sponsor
Oceanside Pharmaceuticals
NDC Codes
1
Dosage Forms
LOTION
Routes
TOPICAL
Active Ingredients
SULFACETAMIDE SODIUM

Indications and Usage

INDICATIONS: This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Warnings

WARNINGS: Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF REACH OF CHILDREN.