PRECAUTIONS 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. Information for Patients Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician. 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 SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%). It is also not known whether SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%) should be given to a pregnant woman only if clearly needed. NURSING MOTHERS It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%). However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%) is administered to a nursing woman. PEDIATRIC USE Safety and effectiveness in children under the age of 12 has not been established.