Sodium Sulfacetamide 9.8 % and Sulfur 4.8 % Cleanser
Sodium Sulfacetamide 9.8 % and Sulfur 4.8 % Cleanser is an FDA drug label for the active ingredient SODIUM SULFACETAMIDE AND SULFUR manufactured by SOHM, Inc administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230503.
Generic: SODIUM SULFACETAMIDE AND SULFUR
Manufacturer: SOHM, Inc
Product Type: HUMAN PRESCRIPTION DRUG
Route: TOPICAL
Dosage Form:
NDC: 50405-852
Application:
Effective: 20230503
Indications & Usage
INDICATIONS: Sulfacetamide Sodium and Sulfur Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage & Administration
DOSAGE AND ADMINISTRATION: Use once daily or as directed by your physician. Wet skin. Apply in a film to entire face, avoiding contact with eyes or mucous membranes. Wait 10 minutes or until dry. Rinse thoroughly with water and pat dry.
Contraindications
CONTRAINDICATIONS: Sulfacetamide Sodium and Sulfur Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfacetamide Sodium and Sulfur Cleanser is not to be used by patients with kidney disease.
Warnings
WARNINGS: Although rare, sensitivity to Sulfacetaminde Sodium 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.
Adverse Reactions
ADVERSE REACTIONS: Although rare, Sulfacetamide Sodium may cause local irritation.