Sodium Sulfacetamide and Sulfer

INDICATIONS Sodium Sulfacetamide 10% – Sulfur 1% Emulsion is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Sodium Sulfacetamide 10% and Sulfur 1% Emulsion is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% and Sulfer 1% Emulsion is not to be used by patietns 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. FOR EXTERNAL USE ONLY . Keep away from eyes. Keep out of reach of children. In case of accidental ingestion contact a poison control center immediately. Keep container tightly closed.

– 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 longterm 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 Sodium Sulfacetamide 10% and Sulfer 1% Emulsion. It is not known whether Sodium Sulfacetamide 10% and Sulfer 1% Emulsion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Silfacetamide 10% and Sulfer 1% Emulsion 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 Sodium Sulfacetamide 10% and Sulfur 1% Emulsion. 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 Sodium Sulfacetamide 10% and Sulfur 1% Emulsion is administered to a nursing woman. PEDIATRIC USE Safety and effectiveness in children under the age of 12 have not been established.

Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects. To report a serious adverse event, please contact Trifluent Pharma, LLC at 1-888-927-5191.

– Category C Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% and Sulfer 1% Emulsion. It is not known whether Sodium Sulfacetamide 10% and Sulfer 1% Emulsion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Silfacetamide 10% and Sulfer 1% Emulsion should be given to a pregnant woman only if clearly needed.

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 10% and Sulfur 1% Emulsion. 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 Sodium Sulfacetamide 10% and Sulfur 1% Emulsion is administered to a nursing woman.

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