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warnings
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. FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.
warnings and cautions
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 ROSANIL ® (sodium sulfacetamide 10% and sulfur 5%) Cleanser. It is also not known whether ROSANIL ® Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ROSANIL ® Cleanser 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 ROSANIL ® Cleanser. 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 ROSANIL ® Cleanser is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children under the age of 12 have not been established.