DailyMed Label: Sodium Sulfacetamide and Sulfur Cleanser

DailyMed Label: Sodium Sulfacetamide and Sulfur Cleanser

2022

DailyMed Prescription

Sodium Sulfacetamide and Sulfur Cleanser

SULFACETAMIDE SODIUM and SULFUR

Bi-Coastal Pharma International LLC

NDC: 42582-800

NDC: 42582-800

Each gram of Sodium Sulfacetamide and Sulfur (sodium sulfacetamide 10% w/w and sulfur 2% w/w) contains 100 mg of sodium sulfacetamide and 20 mg of colloidal sulfur in a vehicle consisting of: 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, xantham gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8 H 9 N 2 NaO 3 S∙H 2 O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Chemical Structure

Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Wash affected areas with Sodium Sulfacetamide 10% and Sulfur 2% Cleanser one to two times daily, or as directed by your physician. Avoid contact with eyes or mucous membranes. 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 drying occurs, it may be controlled by rinsing cleanser off sooner or using cleanser less often.

Sodium Sulfacetamide 10% and Sulfur 2% 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 2% Cleanser is not to be used by patients with kidney disease.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. Long-term studies in animals have not been performed to evaluate carcinogenic potential. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% and Sulfur 2% Cleanser. It is also not known whether Sodium Sulfacetamide 10% and Sulfur 2% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% and Sulfur 2% Cleanser should be given to a pregnant woman only if clearly needed. It is not known whether sodium sulfacetamide is excreted in human milk following topicaI use of Sodium Sulfacetamide 10% and Sulfur 2% Cleanser. However, small amounts of orally administered sulfonamides have been reported to be excreted in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is administered to a nursing woman. Safety and effectiveness in children under the age of 12 has not been established.

Although rare, sodium sulfacetamide may cause local irritation.

Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is supplied in an 8 oz. (227 g) bottle, NDC 42582-800-08. Store at 25°C (77°F); excursions permitted to between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Note: Protect from freezing and excessive heat. The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Keep tube or packet tightly closed. Occasionally, a slight yellowish discoloration may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches.

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

NDC 42582-800-08 Rx Only SODIUM SULFACETAMIDE 10% AND SULFUR 2% Cleanser (sodium sulfacetamide 10%, sulfur 2%) Net Wt. 8 oz. (227 g) Bi-Coastal Pharma International LLC PRINCIPAL DISPLAY PANEL - 227 g Bottle Label