Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
IODOQUINOL (UNII: 63W7IE88K8) (IODOQUINOL - UNII:63W7IE88K8), HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ), ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517) (ALOE VERA LEAF - UNII:ZY81Z83H0X)
Seton Pharmaceuticals
TOPICAL
PRESCRIPTION DRUG
Based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: “Possibly” Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); monliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation. This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
This product is supplied in the following size(s): 48 g Tube, NDC 13925-174-48
unapproved drug other
IODOQUINOL 1% - HYDROCORTISONE ACETATE 2% - ALOE POLYSACCHARIDES 1%- IODOQUINOL 1% - HYDROCORTISONE ACETATE 2% - ALOE POLYSACCHARIDES 1% GEL SETON PHARMACEUTICALS _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._ ---------- IODOQUINOL 1% - HYDROCORTISONE ACETATE 2% ALOE POLYSACCHARIDES 1% GEL RX ONLY DESCRIPTION: Each gram contains 20 mg of hydrocortisone acetate, 10 mg of iodoquinol and 10 mg of aloe polysaccharide in a vehicle consisting of: amino methylpropanol 95%, benzyl alcohol, carbomer, citric acid anhydrous, D&C yellow #10, FD&C blue #1, glycerin, glyceryl polymethacrylate, magnesium aluminum silicate, palmitoyl oligopeptide, PPG-20 methyl glucose ether, propylene glycol, purified water and SD Alcohol 40B. Hydrocortisone acetate is an anti-inflammatory and antipruritic agent. Chemically, hydrocortisone acetate is [Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-ß)-] with the molecular formula (C23H32O6) and is represented by the following structural formula: Iodoquinol is an antifungal and antibacterial agent. Chemically, Iodoquinol is [5,7-diiodo-8-quinolinol] with the molecular formula (C9H5I2NO) and is represented by the following structural formula: Aloe Polysaccharides are a concentrated, water soluble subcomponent of Aloe Vera with a mono-sugar ratio of Man : Gal : Glc: 40 : 1.4 : 1.0, linkage of 1-4 ß - linkage, O-Acetyl group of 25% of sugar units, and specific rotation of [α]D= -3.98˚ at 23.2˚ C. Average molecular weight is 80,000 daltons. Chemically, Aloe Polysaccharides is represented by the following structural formula: CLINICAL PHARMACOLOGY: Hydrocortisone acetate has anti-inflammatory, antipruritic and vasoconstrictive properties. While the mechanism of anti-inflammatory activity is unclear, there is evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in humans. Iodoquinol h Прочитайте повний документ