PRECAUTIONS General If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be very 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 an 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 CERISA™ WASH. It is also not known whether CERISA™ WASH can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CERISA™ WASH 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 topical use of CERISA™ WASH. 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 CERISA™ WASH is administered to a nursing woman. Pediatric Use Safety and effectiveness in children under the age of 12 have not been established.