Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
Sulfacetamide Sodium (UNII: 4NRT660KJQ) (Sulfacetamide - UNII:4965G3J0F5), Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)
Trinity Pharmaceuticals, LLC
Sulfacetamide Sodium
Sulfacetamide Sodium 9 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is not to be used by patients with kidney disease.
Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is available in in a 16 oz (454 g) bottle, NDC 54295-301-21. 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 TRINITY 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 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)sulfony]- acetamide, monosodium salt, monohydrate. The structural formula is: Each mL of Sodium Sulfacetamide 9% & Sulfur 4.5% Wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation consisting of: aloe vera, fragrance, butylated hydroxytoluene, cetyl alcohol, disodium EDTA, disodium oleamido MEA sulfosuccinate, glyceryl stearate (and) PEG-100 stearate, green tea extract, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl tau rate, sodium thiosulfate, stearyl alcohol and xanthan gum. CLINICAL PHARMACOLOGY The most widely accepted mechanism of action of sulfonamides in 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 AND USAGE 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% & Læs hele dokumentet