Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
Sulfacetamide (UNII: 4965G3J0F5) (Sulfacetamide - UNII:4965G3J0F5), Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)
Galderma Laboratories, L.P.
Sulfacetamide
Sulfacetamide 10 g in 100 g
TOPICAL
PRESCRIPTION DRUG
ROSANIL® Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. ROSANIL® Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. ROSANIL® Cleanser is not to be used by patients with kidney disease.
ROSANIL® (sodium sulfacetamide 10% and sulfur 5%) Cleanser is available in a 6 oz tube. NDC 0299-3839-06 Store at controlled room temperature 20° - 25°C (68° - 77°F). Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA Manufactured by: DPT Laboratories, Ltd. San Antonio, Texas 78215 USA GALDERMA is a registered trademark. www.rosanil.com 325076-0706 Revised: July 2006
unapproved drug other
ROSANIL - SODIUM SULFACETAMIDE, SULFER SOLUTION GALDERMA LABORATORIES, L.P. _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._ ---------- ROSANIL® CLEANSER (SODIUM SULFACETAMIDE 10% AND SULFUR 5%) 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 ROSANIL (sodium sulfacetamide 10% and sulfur 5%) Cleanser contains: ACTIVE: sodium sulfacetamide 10% (100 mg), sulfur 5% (50 mg). INACTIVE: butylated hydroxytoluene, edetate disodium, emulsifying wax, hydrochloric acid, light mineral oil, methylparaben, PPG-2 hydroxyethyl coco/isostearamide, propylparaben, purified water, sodium cocoyl isethionate, sodium lauryl sulfoacetate (and) disodium laureth sulfosuccinate, and sodium thiosulfate. 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: ROSANIL Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. CONTRAINDICATIONS: ROSANIL Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other comp Прочитать полный документ