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

Rx Only

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Each gram of Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser contains 98 mg of sodium sulfacetamide and 48 mg of colloidal sulfur in a vehicle consisting of Aloe Vera leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium Laureth Sulfate, Sodium Thiosulfate, Stearyl alcohol, Triacetin, Xanthan Gum

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C8H9N2NaO3S∙H2O with molecular weight of 254.24. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.

Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There is no clinical data available on the degree and rate of systemic absorption of this product when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported.

The following in vitro data is available but the clinical significance is unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces. 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.

This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

This product is contraindicated in persons with known or suspected hypersensitivity to sulfonamides, sulfur or any other ingredients of this product. This product is not to be used by patients with kidney disease.

Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome.

KEEP OUT OF REACH OF CHILDREN.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Avoid contact with eyes, lips and mucous membranes.

Wash affected areas once or twice daily, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10 to 20 seconds working into a full lather, rinse thoroughly and pat dry. If skin dryness occurs, it may be controlled by rinsing cleanser off sooner or using less frequently.

See booklet for full prescribing information.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Protect from freezing and excessive heat. Keep bottle tightly closed.

To report a serious adverse event or obtain product information, please contact Westminster Pharmaceuticals at 1-844-221-7294.

Manufactured for:
Westminster Pharmaceuticals, LLC
Nashville, TN 37217

Rev. 12/22

NDC 69367-244-10
Rx Only

Sodium
Sulfacetamide 9.8%
and Sulfur 4.8%
Cleanser

For External Use Only

Net Wt. 10 oz
(285 g)

Westminster
Pharmaceuticals