desoximetasone DESOXIMETASONE VIONA PHARMACEUTICALS INC FDA Approved Desoximetasone Cream USP, 0.25% contains the active synthetic corticosteroid desoximetasone, USP. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone, USP in an emollient cream consisting of cetostearyl alcohol, edetate disodium dihydrate, isopropyl myristate, lanolin alcohols, mineral oil, purified water and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C 22 H 29 FO 4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is: Desoximetasone Cream USP, 0.25%
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Substance Desoximetasone
Route
TOPICAL
Applications
ANDA205620

Drug Facts

Composition & Profile

Strengths
0.25 % 15 g 60 g 100 g
Quantities
01 count
Treats Conditions
Indications And Usage Desoximetasone Cream 0 25 Is Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses
Pill Appearance
Color: white

Identifiers & Packaging

Container Type UNKNOWN
UPC
0372578091019
UNII
4E07GXB7AU
Packaging

HOW SUPPLIED Desoximetasone Cream USP, 0.25% is supplied in 15 gram, 60 gram and 100 gram tubes. NDC 72578-091-01 in tube of 15 gm NDC 72578-091-02 in tube of 60 gm NDC 72578-091-03 in tube of 100 gm Storage Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] Keep this and all medications out of the reach of children. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 72578-091-01 in tube of 15gm Desoximetasone Cream USP, 0.25% Rx only 15 gm Desoximetasone Cream USP, 0.25% Desoximetasone Cream USP, 0.25%

Package Descriptions
  • HOW SUPPLIED Desoximetasone Cream USP, 0.25% is supplied in 15 gram, 60 gram and 100 gram tubes. NDC 72578-091-01 in tube of 15 gm NDC 72578-091-02 in tube of 60 gm NDC 72578-091-03 in tube of 100 gm Storage Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] Keep this and all medications out of the reach of children. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 72578-091-01 in tube of 15gm Desoximetasone Cream USP, 0.25% Rx only 15 gm Desoximetasone Cream USP, 0.25% Desoximetasone Cream USP, 0.25%

Overview

Desoximetasone Cream USP, 0.25% contains the active synthetic corticosteroid desoximetasone, USP. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone, USP in an emollient cream consisting of cetostearyl alcohol, edetate disodium dihydrate, isopropyl myristate, lanolin alcohols, mineral oil, purified water and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C 22 H 29 FO 4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is: Desoximetasone Cream USP, 0.25%

Indications & Usage

Desoximetasone cream, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & Administration

Apply a thin film of desoximetasone cream USP, 0.25% to the affected skin areas twice daily. Rub in gently.

Warnings & Precautions
WARNINGS Desoximetasone cream, 0.25% is not for ophthalmic use. Keep out of reach of children.
Contraindications

Topical corticosteroids 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 are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an 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, and miliaria. In controlled clinical studies the incidence of adverse reactions was low (0.8%) for desoximetasone cream, 0.25% and included burning, folliculitis, and folliculo-pustular lesions. The incidence of adverse reactions was also 0.8% for desoximetasone cream, 0.05% and included pruritus, erythema, vesiculation, and burning sensation.


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