sulfacetamide sodium and sulfur Sodium Sulfacetamide - Sulfur

INDICATIONS Sodium Sulfacetamide 9% - Sulfur 4.25% Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

DOSAGE AND ADMINISTRATION SHAKE WELL before use. Cleanse affected areas. Apply Sodium Sulfacetamide 9% - Sulfer 4.25% Suspension once or twice daily to affected areas, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a full lather, rinse thoroughly and pat dry. If skin dryness occurs, it may be controlled by rinsing off Sodium Sulfacetamide 9% - Sulfer 4.25% sooner or using less often.

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. Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Avoid contact with eyes, lips and mucous membranes. KEEP OUT OF REACH OF CHILDREN. Keep container tightly closed.

CONTRAINDICATIONS Sodium Sulfacetamide 9% - Sulfer 4.25% Supesnion is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 9% - Sulder 4.25% Supension is not to be used by patients with kidney disease.

Drug Interactions This product is incompatible with silver preparations.

PREGNANCY Category C Animal reproduction studies have not been conducted with Sodium Sulfacetamide 9% - Sulfer 4.25% Suspension. It is not known whether Sodium Sulfacetamide 9% - Sulfer 4.25% Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Silfacetamide 9% - Sulfer 4.25% should be given to a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

NURSING MOTHERS It is not known whether this drug is excreted in the human milk. 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 9% - Sulfur 4.25% Supesnion is administered to a nursing woman.

ADVERSE REACTIONS Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS ). Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS or obtain product information, contact Allegis Pharmacuticals, LLC at 1-866-633-9033 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.