displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Sulfacetamide sodium is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sulfacetamide sodium is N-[(4-aminophenyl) sulfonyI]-acetamide, monosodium salt, monohydrate. The structural formula is:
Each gram of sulfacetamide sodium USP 9% and sulfur USP 4.5% contains 90 mg of Sodium Sulfacetamide USP and 45 mg of Sulfur USP in a cream containing: Aloe Barbadensis (Aloe Vera) Leaf Extract, Butylated Hydroxytoluene, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl Alcohol, Disodium Oleamido MEA Sulfosuccinate, Edetate Disodium, Fragrance, Glycerin, Glyceryl Monostearate, Magnesium Aluminum Silicate, Methylparaben, PEG-100 Stearate, Propylparaben, Purified Water, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol, Xanthan Gum.
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Sulfacetamide sodium and sulfur wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Sulfacetamide sodium and sulfur wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfacetamide sodium and sulfur wash is not to be used by patients with kidney disease.
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Although rare, sensitivity to sulfacetamide 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.
FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Although rare, sulfacetamide sodium may cause local irritation.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
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.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Sulfacetamide sodium 9% and sulfur 4.5% wash is supplied in
16 oz (454 g) bottle NDC 42582-500-21
PRINCIPAL DISPLAY PANEL – 454 g Bottle Carton
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC # 42582-500-21
Sodium Sulfacetamide 9%
For topical use only • Not for
Bi-Coastal Pharma International LLC
NET WT. 16 OZ. (454g)