Drug Facts
Composition & Profile
Identifiers & Packaging
Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is available in 6 oz (170 g) bottle NDC 87026-202-06 12 oz (340 g) bottle NDC 87026-202-12; Aspen Medical NDC 87026-202-06 Rx Only Sodium Sulfacetamide & Sulfur Sodium Sulfacetamide 10% Sulfur 5% 10%/5% Cleanser For External Use only NET WT. 6 OZ. (170 g) Label
- Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is available in 6 oz (170 g) bottle NDC 87026-202-06 12 oz (340 g) bottle NDC 87026-202-12
- Aspen Medical NDC 87026-202-06 Rx Only Sodium Sulfacetamide & Sulfur Sodium Sulfacetamide 10% Sulfur 5% 10%/5% Cleanser For External Use only NET WT. 6 OZ. (170 g) Label
Overview
Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl)sulfonyl]-acetamide monosodium salt, monohydrate. The structural formula is: Structure
Indications & Usage
Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea seborrheic dermatitis.
Dosage & Administration
Wash affected areas once or twice daily, or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and leberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds working into a full leather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing cleanser off sooner or using less often. FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR OPTHALMIC USE. (KEEP AWAY FROM EYES). KEEP OUT OF REACH OF CHILDREN (Shake well before use)
Warnings & Precautions
Although it is 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.
Contraindications
Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is not to be used by patients with kidney disease.
Adverse Reactions
Although rare, sodium sulfacetamide may cause local irritation.
Storage & Handling
Store at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature. Protect from freezing. In case of accidental ingestion contact a Poison Controll Center immediately. Keep container tightly closed. You may report side effects by calling the FDA at 1-800-FDA-1088