Sumaxin Cleansing Pads

INDICATIONS Sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

DOSAGE AND ADMINISTRATION Wash affected area(s) with cleansing pad once or twice daily, or as directed by your physician. Wet area(s) with water. Wet pad with a little water and work into a full lather. Cleanse area(s) with pad for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry. Discard pad. Do not flush.

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.

CONTRAINDICATIONS Sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are not to be used by patients with kidney disease.

PREGNANCY Category C Animal reproduction studies have not been conducted with Sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads . It is also not known whether Sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads 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 Sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads . 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 Sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are administered to a nursing woman.

ADVERSE REACTIONS Although rare, sodium sulfacetamide may cause local irritation.