INDICATIONS SODIUM SULFACETAMIDE 10% - SULFUR 5% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

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.