Sodium Sulfacetamide 10 Sulfur 2 Cleanser

INDICATIONS: SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

DOSAGE AND ADMINISTRATION: Wash affected areas with SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER 1 to 2 times daily or as directed by a physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10 to 20 seconds working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing cleanser off sooner or using cleanser less often.

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.

CONTRAINDICATIONS: SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is not to be used by patients with kidney disease.

Pregnancy: Category C. Animal reproduction studies have not been conducted with SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER. It is also not known whether SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether sodium sulfacetamide is excreted in human milk following topicaI use of SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER. However, small amounts of orally administered sulfonamides have been reported to be excreted in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is administered to a nursing woman.

ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects.