Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Desoximetasone cream USP, 0.25% is available as follows: 15 gram tube: NDC 0472-0478-15 60 gram tube: NDC 0472-0478-60 Store at controlled room temperature between 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 1/2020; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Actavis NDC 0472-0478-15 Desoximetasone Cream USP, 0.25% Rx Only FOR TOPICAL USE ONLY NOT FOR ORAL, OPTHALMIC, OR INTRAVAGINAL USE Keep this and all medication out of the reach of children. NET WT. 15 g 1
- HOW SUPPLIED Desoximetasone cream USP, 0.25% is available as follows: 15 gram tube: NDC 0472-0478-15 60 gram tube: NDC 0472-0478-60 Store at controlled room temperature between 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 1/2020
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Actavis NDC 0472-0478-15 Desoximetasone Cream USP, 0.25% Rx Only FOR TOPICAL USE ONLY NOT FOR ORAL, OPTHALMIC, OR INTRAVAGINAL USE Keep this and all medication out of the reach of children. NET WT. 15 g 1
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 base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. The chemical name of desoximetasone, USP is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone, USP 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: 8b7da440-figure-01
Indications & Usage
Desoximetasone cream USP, 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 Keep out of reach of children.
Contraindications
Desoximetasone cream USP, 0.25% 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 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 were low (0.8%) for desoximetasone cream USP, 0.25%, and included burning, folliculitis, and folliculo-pustular lesions.
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