psorcon DIFLORASONE DIACETATE SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Approved PSORCON ® (diflorasone diacetate cream USP), 0.05% contains the active compound diflorasone diacetate, a synthetic corticosteroid for topical dermatological use. Chemically, diflorasone diacetate is 6α, 9α-difluoro-11β,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21 diacetate, with the empirical formula C 26 H 32 F 2 O 7 , a molecular weight of 494.5, and the following structural formula: Each gram of PSORCON ® (diflorasone diacetate cream USP), 0.05% contains 0.5 mg diflorasone diacetate in a cream base consisting of butylated hydroxytoluene, cetyl alcohol, citric acid, glyceryl stearate/PEG 100 stearate, isopropyl myristate, lanolin alcohol, mineral oil, monobasic sodium phosphate, polyoxyl 40 stearate, polysorbate 60, propylene glycol, purified water, sorbitan monostearate and vegetable oil. Chemical Structure
FunFoxMeds box
Route
TOPICAL
Applications
ANDA075508

Drug Facts

Composition & Profile

Strengths
0.05 % 60 g
Treats Conditions
Indication And Usage Psorcon Diflorasone Diacetate Cream Usp 0 05 Is A High Potency Corticosteroid Indicated For The 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 PSORCON ® (diflorasone diacetate cream USP), 0.05% is available in a 60 g (51672-5292-3) tube. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep tightly closed.; PRINCIPAL DISPLAY PANEL - 60 GRAM Tube Carton 60 GRAMS Rx only NDC 51672-5292-3 psorcon ® (diflorasone diacetate cream, USP) 0.05% For External Use Only. Not for Ophthalmic Use. Keep this and all medications out of the reach of children. CREAM PRINCIPAL DISPLAY PANEL - 60 GRAM Tube Carton

Package Descriptions
  • HOW SUPPLIED PSORCON ® (diflorasone diacetate cream USP), 0.05% is available in a 60 g (51672-5292-3) tube. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep tightly closed.
  • PRINCIPAL DISPLAY PANEL - 60 GRAM Tube Carton 60 GRAMS Rx only NDC 51672-5292-3 psorcon ® (diflorasone diacetate cream, USP) 0.05% For External Use Only. Not for Ophthalmic Use. Keep this and all medications out of the reach of children. CREAM PRINCIPAL DISPLAY PANEL - 60 GRAM Tube Carton

Overview

PSORCON ® (diflorasone diacetate cream USP), 0.05% contains the active compound diflorasone diacetate, a synthetic corticosteroid for topical dermatological use. Chemically, diflorasone diacetate is 6α, 9α-difluoro-11β,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21 diacetate, with the empirical formula C 26 H 32 F 2 O 7 , a molecular weight of 494.5, and the following structural formula: Each gram of PSORCON ® (diflorasone diacetate cream USP), 0.05% contains 0.5 mg diflorasone diacetate in a cream base consisting of butylated hydroxytoluene, cetyl alcohol, citric acid, glyceryl stearate/PEG 100 stearate, isopropyl myristate, lanolin alcohol, mineral oil, monobasic sodium phosphate, polyoxyl 40 stearate, polysorbate 60, propylene glycol, purified water, sorbitan monostearate and vegetable oil. Chemical Structure

Indications & Usage

INDICATION AND USAGE PSORCON ® (diflorasone diacetate cream USP), 0.05% is a high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & Administration

PSORCON ® (diflorasone diacetate cream USP), 0.05% should be applied to the affected area twice daily.

Warnings & Precautions
No warnings available yet.
Contraindications

PSORCON ® (diflorasone diacetate cream USP), 0.05% is 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 infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infections, skin atrophy, striae, and miliaria.

Storage & Handling

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


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