SULFACETAMIDE SODIUM, SULFUR

Product Type: HUMAN PRESCRIPTION DRUG

Route: TOPICAL

Dosage Form:

NDC: 52187-548

Application:

Effective: 20220331

INDICATIONS AND USAGE: This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

DOSAGE AND ADMINISTRATION: Cleanse affected areas. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily or as directed by a physician.

CONTRAINDICATIONS: 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.

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.

ADVERSE REACTIONS: 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 (see WARNINGS).