Sodium sulfacetamide

FDA Drug Profile — Sodium sulfacetamide

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 Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Warnings

WARNINGS Although rare, sensitivity to sodium sulfacetaminde may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved. FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.