Sodium Sulfacetamide 10% wash

Sodium Sulfacetamide 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.

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes, lips and mucous membranes. Sulfonamides are known to cause sevens-johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topica ly. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported.

In one of these cases, there was a fatal outcome.

This product is incompatible with silver preparations.

PREGNANCY Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only If clearly needed or when potential benefits outweigh potential hazards to the fetus.

Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported.