Label: SODIUM SULFACETAMIDE, SULFUR- sulfacetamide sodium and sulfur liquid

Rx Only

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Each gram of Sodium Sulfacetamide 10% and Sulfur 5% Cleanser contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a formulation containing ammonium lauryl sulfate, butylated hydroxytoluene, cetyl alcohol, cocamidopropyl betaine, disodium EDTA, glycerin, glyceryl stearate SE, guar gum, methylparaben, PEG-100 stearate, propylene glycol, propylparaben, purified water, sodium thiosulfate, stearyl alcohol, triacetin.

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:

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, sodium sulfacetamide 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 known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Sodium Sulfacetamide 10% and 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% and Sulfur 5% Cleanser is not to be used by patients with kidney disease.

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.

FOR EXTERNAL USE ONLY. Keep away from eyes. keep out of reach of children. In case of accidental ingestion contact a poison control center immediately. Keep container tightly closed.

Although rare, sodium sulfacetamide may cause local irritation.

Call your doctor for medical advice about side effects. To report a serious adverse event, please contact Westminster Pharmaceuticals at 1-844-221-7294

Apply Sodium Sulfacetamide 10% and Sulfur 5% Cleanser 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 drying occurs, it may be controlled by rinsing off Sodium Sulfacetamide 10% and Sulfur 5% Cleanser sooner or using less often.

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is available in 6 oz. (170.3 g) bottles, NDC 69367-247-06 and 12 oz. (340.2 g) bottles, NDC 69367-247-12.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person's professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.

Manufactured for:
Westminster Pharmaceuticals, LLC
Nashville, TN 37217

Rev. 05/20

NDC 69367-247-06
Rx Only

Sodium
Sulfacetamide 10%
and Sulfur 5%
Cleanser

FOR EXTERNAL USE ONLY

6 oz (170.3 g)

Westminster
Pharmaceuticals