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Sodium Sulfacetamide and Sulfur

FDA Drug Profile — Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser, SODIUM SULFACETAMIDE, SULFUR, Sodium Sulfacetamide and Sulfur, Sodium Sulfacetamide 9.8 % and Sulfur 4.8 % Cleanser, Sodium Sulfacetamide 8% Sulfur 4% CLEANSER

Drug Details

Generic Name
Sodium Sulfacetamide and Sulfur
Brand Names
Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser, SODIUM SULFACETAMIDE, SULFUR, Sodium Sulfacetamide and Sulfur, Sodium Sulfacetamide 9.8 % and Sulfur 4.8 % Cleanser, Sodium Sulfacetamide 8% Sulfur 4% CLEANSER, Sodium Sulfacetamide 10 % and Sulfur 2 % Cleanser
Application Number
Sponsor
SOHM, Inc
NDC Codes
8
Dosage Forms
LIQUID, CREAM, SUSPENSION, LOTION, SOLUTION
Routes
TOPICAL
Active Ingredients
SULFACETAMIDE SODIUM, SULFUR

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.