Diflorasone Diacetate DIFLORASONE DIACETATE SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Approved 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
FunFoxMeds box
Route
TOPICAL
Applications
ANDA075331

Drug Facts

Composition & Profile

Strengths
0.05 % 15 g 30 g 60 g
Quantities
2 count
Treats Conditions
Indications And Usage Topical Corticosteroids Are Indicated For Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOX
UNII
7W2J09SCWX
Packaging

HOW SUPPLIED Diflorasone Diacetate Ointment USP, 0.05% is available in 15 gram (NDC 51672-1295-1), 30 gram (NDC 51672-1295-2) and 60 gram (NDC 51672-1295-3) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL - 30 g Tube Carton NDC 51672-1295-2 30 g Diflorasone Diacetate Ointment USP, 0.05% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Package Descriptions
  • HOW SUPPLIED Diflorasone Diacetate Ointment USP, 0.05% is available in 15 gram (NDC 51672-1295-1), 30 gram (NDC 51672-1295-2) and 60 gram (NDC 51672-1295-3) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton NDC 51672-1295-2 30 g Diflorasone Diacetate Ointment USP, 0.05% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Overview

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

Indications & Usage

Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & 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.

Warnings & Precautions
No warnings available yet.
Contraindications

Topical steroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Adverse Reactions

The following local adverse reactions have been reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin atrophy Striae Miliaria

Storage & Handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].


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