FOR EXTERNAL USE ONLY.   
NOT FOR OPHTHALMIC USE.

DESCRIPTION:  Each gram contains 100 mg of sodium sulfacetamide USP in a vehicle consisting of: cocamidopropyl betaine, disodium EDTA, methyl paraben, PEG-60 almond triglyceride, PEG-6 caprylic/capric glycerides, PEG-150 pentaerythrityl tetrastearate, purified water, sodium laureth sulfate, and sodium thiosulfate. 

Chemically, it is Acetamide N-[4-aminophenyl)sulfonyl]-, monosodium salt, monohydrate, with the following structural formula: 

Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform, and in ether.

CLINICAL PHARMACOLOGY:  Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There are no clinical data available on the degree and rate of systemic competition with para-aminobenzoic acid absorption of Sodium Sulfacetamide 10% Wash when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported. The following in vitro data are available but their clinical significance is unknown. Organisms which show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.

INDICATIONS AND USAGE:  Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dematoses: seborrheic dermatitis and sebonthea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

CONTRAINDICATIONS:  Sodium Sulfacetamide 10% Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.

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 the reach of children.

PRECAUTIONS: For external use only. Not for ophthalmic use. General:  Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If Sodium Sulfacetamide 10% Wash produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded, or severely burned areas. Under these circumstances, potentially any of the adverse effects produced by the systemic administration of these agents could occur and appropriate observations and laboratory determinations should be performed.