Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ), IODOQUINOL (UNII: 63W7IE88K8) (IODOQUINOL - UNII:63W7IE88K8)
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); moniliasis; 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.
1 oz. tubes, NDC 13925-175-01 To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 v1 Rev. 10/2018
unapproved drug other
HYDROCORTISONE IODOQUINOL- HYDROCORTISONE, IODOQUINOL CREAM 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._ ---------- HYDROCORTISONE 1%-IODOQUINOL 1% CREAM RX ONLY DESCRIPTION: Each gram contains 10 mg of hydrocortisone and 10 mg of iodoquinol in a vehicle consisting of: ceteareth-6, ceteareth-25, cetyl alcohol, chloroxylenol, citric acid, glyceryl stearate SE, mineral oil, propylene glycol, purified water, stearyl alcohol, and xanthan gum. Paraben Free. Chemically, hydrocortisone is [Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-,(11 B)-1 with the molecular formula (C21 H3005) and is represented by the following structural formula: and iodoquinol, 5,7-diiodo-8-quinolinol (C9H5l2NO) is represented by the following structural formula: Hydrocortisone is an anti-inflammatory and antipruritic agent, while iodoquinol is an antifungal and antibacterial agent. CLINICAL PHARMACOLOGY: Hydrocortisone 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. lodoquinol has both antifungal and antibacterial properties. PHARMACOKINETICS : The extent of percutaneous absorption of topical steroids is determined by many factors including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings. Hydrocortisone can be absorbed from normal intact skin. Inflammation and/or other inflammatory disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, hydrocortisone is metabolized in the liver and most body tissue to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These ar Прочитать полный документ