Rx Only

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

DESCRIPTION: Each mL of SODIUM SULFACETAMIDE 10% CLEANSING GEL contains 100 mg of sodium sulfacetamide, USP in a formulation containing Citric acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate, Methylparaben, PEG-6 Caprylic/Capric Glycerides, PEG-60 Almond Glycerides, PEG-150 Pentaerythrityl Tetrastearate, Polysorbate 60, Sodium Lauryl Sulfate, Sodium Thiosulfate, Water, Xanthan Gum. 

Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: 

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 is no clinical data available on the degree and rate of systemic absorption of SODIUM SULFACETAMIDE 10% CLEANSING GEL when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported. The following in vitro data is available but the clinical significance is unknown. Organisms that 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% CLEANSING GEL is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea 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% CLEANSING GEL 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% CLEANSING GEL 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, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed.