sulfacetamide sodium and sulfur

FDA Drug Profile — SODIUM SULFACETAMIDE, SULFUR, sulfacetamide sodium and sulfur Sodium Sulfacetamide - Sulfur, Sumaxin CP

Drug Details

Generic Name
sulfacetamide sodium and sulfur
Brand Names
SODIUM SULFACETAMIDE, SULFUR, sulfacetamide sodium and sulfur Sodium Sulfacetamide - Sulfur, Sumaxin CP
Application Number
Sponsor
Westminster Pharmaceuticals, LLC
NDC Codes
4
Dosage Forms
LIQUID, SUSPENSION, KIT
Routes
TOPICAL
Active Ingredients
SULFACETAMIDE SODIUM, SULFUR

Indications and Usage

INDICATIONS: SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Warnings

WARNINGS: Although rare, sensitivity to sodium sulfacetamide 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. 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.