RVP

Drug Catalog - Product Detail

DIFLORASONE DIACETATE OINT 0.05% 60GM

NDC Mfr Size Str Form
71800-0009-60 INNOVIDA PHARMACEUTIQUE 60 0.05% OINTMENT
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PACKAGE FILES

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Generic Name
DIFLORASONE DIACETATE
Substance Name
DIFLORASONE DIACETATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA075331
Description
DESCRIPTION Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base. Chemically, diflorasone diacetate is 6α, 9-difluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-diacetate. The structural formula is represented below: molecular formula: C 26 H 32 F 2 O 7 molecular weight: 494.54 Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base of glyceryl monostearate, propylene glycol and white petrolatum. Chemical Structure
How Supplied
HOW SUPPLIED Diflorasone Diacetate Ointment USP, 0.05% is available in 60 gram (NDC 71800-009-60) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Indications & Usage
INDICATIONS AND USAGE Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration
DOSAGE AND ADMINISTRATION Diflorasone diacetate ointment should be applied to the affected area as a thin film from one to three times daily depending on the severity or resistant nature of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.