Země: Spojené státy
Jazyk: angličtina
Zdroj: 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 9 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
INDICATIONS: Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. CONTRAINDICATIONS: Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or ony other component of this preparation. Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is not to be used by patients with kidney disease.
HOW SUPPLIED: Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is available in 16 oz (454 g) bottles, NDC 42192-144-16. 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). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Protect from freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
unapproved drug other
SODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH- SULFACETAMIDE SODIUM AND SULFUR RINSE 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._ ---------- SODIUM SULFACETAMIDE 9% - SULFUR 4.5% WASH IN A VEHICLE CONTAINING GREEN TEA AND ALOE RX ONLY DESCRIPTION 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: Each gram of Sodium Sulfacetamide 9% - Sulfur 4% Wash contains 90 mg of Sodium Sulfacetamide and 45 mg of Sulfur in a formulation containing: purified water, sodium cocoyl isethionate, magnesium aluminum silicate, disodium oleamido MEA sulfosuccinate, sodium methyl cocoyl taurate, glyceryl stearate (and) PEG-100 stearate, stearyl alcohol, cetyl alcohol, methyl paraben, propyl paraben, butylated hydroxytoluene, xanthan gum, sodium thiosulfate, green tea extract, aloe vera, disodium EDTA, and fragrance. 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 not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids. INDICATIONS: Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. CONTRAI Přečtěte si celý dokument