Label: SULFACETAMIDE SODIUM AND SULFUR cream

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 10% and Sulfur USP 5% contains 100 mg of Sodium Sulfacetamide USP and 50 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.

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.

Sulfacetamide Sodium and Sulfur cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

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.

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.

Although rare, Sulfacetamide Sodium may cause local irritation.

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.

Sulfacetamide Sodium 10% and Sulfur 5% cleanser is supplied in
6 oz (170 g) tube       NDC 42582-600-23
12 oz (340 g) bottle   NDC 42582-600-20

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

Rx Only

Manufactured for:
Bi-Coastal Pharma International LLC
Shrewsbury, New Jersey 07702 USA

NDC # 42582-600-20

Sodium
Sulfacetamide
10% &
Sulfur 5%
Cleanser

For topical use only • Not
for ophthalmic use

Rx Only

Bi-Coastal Pharma International LLC

NET WT. 12 OZ. (340g)