Sulfacetamide Sodium and Sulfur

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

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.

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.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. General: If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential. 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.

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

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.

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.

Safety and effectiveness in children under the age of 12 has not been established.