Drug Catalog - Product Detail
FLURANDRENOLIDE CREAM USP, 0.05% 60GM X2 TUBES
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 24470-0919-12 | CINTEX | 60 | 0.05% | CREAM |
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Description
DESCRIPTION Flurandrenolide, USP is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One g dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione,6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 16α)-; its empirical formula is C 24 H 33 FO 6 . The structure is as follows: Each gram of Flurandrenolide Cream USP, 0.05% contains 0.5 mg (1.145 μmol; 0.05%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. structure.jpg
How Supplied
HOW SUPPLIED Flurandrenolide Cream USP, 0.05%, a white cream is available as follows: NDC 24470-919-60 60g tube NDC 24470-919-12 120g (2 x 60g tubes) Store at 20° to 25° C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Keep tightly closed and protect from light. Manufactured by: Medical Products Laboratories Philadelphia, PA 19115 Manufactured for: Cintex Services, LLC 9330 LBJ Freeway, Suite 900 Dallas, TX 75243 827377 v1 Rev. 04/17
Indications & Usage
INDICATIONS AND USAGE Flurandrenolide USP is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration
DOSAGE AND ADMINISTRATION For moist lesions, a small quantity of the cream should be rubbed gently into the affected areas 2 or 3 times a day. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Flurandrenolide Cream USP, 0.05% should not be used with occlusive dressings unless directed by a physician. Tight-fitting diapers or plastic pants may constitute occlusive dressings.