Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5), SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)
Acella Pharmaceuticals, LLC
SULFACETAMIDE SODIUM
SULFACETAMIDE SODIUM 100 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
INDICATIONS: BP Cleansing Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. CONTRAINDICATIONS: BP Cleansing Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. BP Cleansing Wash is not to be used by patients with kidney disease. Pediatric Use - Safety and effectiveness in children under the age of 12 have not been established.
HOW SUPPLIED: BP Cleansing Wash is available in a 16 fl. oz. (473 mL) bottle, NDC 42192-103-16. Store BP Cleansing Wash at controlled room temperature 15°-30° C (59°-86° F). Protect from freezing.
unapproved drug other
BP CLEANSING WASH- SODIUM SULFACETAMIDE AND SULFUR LIQUID ACELLA PHARMACEUTICALS, LLC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- BP CLEANSING WASH (SODIUM SULFACETAMIDE 10% AND SULFUR 4%) IN A UREA VEHICLE DESCRIPTION: Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Each mL of Sodium Sulfacetamide 10% and Sulfur 4% contains 100 mg of sodium sulfacetamide and 40 mg of sulfur in an emulsion base containing urea 10%, butylated hydroxytoluene, cetyl alcohol, disodium EDTA, disodium oleamido MEA sulfosuccinate, glyceryl stearate and PEG 100 stearate, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, white petrolatum and xanthan gum. CLINICAL PHARMACOLOGY: 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. INDICATIONS: BP Cleansing Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. CONTRAINDICATIONS: BP Cleansing Wash is contraindicated for use by patients having known hypersens Citiți documentul complet