Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M)
Physicians Total Care, Inc.
fluocinolone acetonide
fluocinolone acetonide 0.11 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
Derma-Smoothe/FS® is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. This product contains refined peanut oil NF (see PRECAUTIONS section).
Derma-Smoothe/FS® is supplied in bottles containing 4 fluid ounces. It is labeled as Scalp Oil (NDC # 54868-5351-0 ). Scalp Oil is supplied with 2 shower caps. Keep tightly closed. Store at 25°C (68° to 77°F); excursions permitted to 15°–30°C (59°–86° F) [see USP Controlled Room Temperature]. CAUTION: Rx only MANUFACTURED and DISTRIBUTED BY: Hill Dermaceuticals, Inc. Sanford, Florida 32773 Rev. CODE 171A177 Date: 6/07 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146
New Drug Application
DERMA-SMOOTHE/FS - FLUOCINOLONE ACETONIDE OIL PHYSICIANS TOTAL CARE, INC. ---------- DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01% (SCALP OIL) For Topical Use Only- Not for Oral, Ophthalmic, or Intravaginal Use DESCRIPTION Derma-Smoothe/FSTopical Oil contains fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21- dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as Derma-Smoothe/FS 0.01% fluocinolone acetonide for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% for chronic eczematous external otitis. Chemically, fluocinolone acetonide is C H F O . It has the following structural formula: Fluocinolone acetonide in Derma-Smoothe/FS has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of Derma-Smoothe/FS contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil NF and fragrances . Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. CLINICAL PHARMACOLOGY Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the ® ® ® 24 30 2 6 ® ® 2 biosynthesis of potent mediators of inflammation such as prost Perskaitykite visą dokumentą