Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Desoximetasone Ointment USP, 0.25% is supplied in 15 gram, 60 gram and 100 gram tubes. NDC 72578-095-01 in tube of 15 gm NDC 72578-095-02 in tube of 60 gm NDC 72578-095-03 in tube of 100 gm Storage Store at 20°-25°C (68° and 77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Temperature].; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Desoximetasone Ointment USP, 0.25% NDC – 72578-095-01 15 gm tube Desoximetasone oinment, 0.25 carton label
- HOW SUPPLIED Desoximetasone Ointment USP, 0.25% is supplied in 15 gram, 60 gram and 100 gram tubes. NDC 72578-095-01 in tube of 15 gm NDC 72578-095-02 in tube of 60 gm NDC 72578-095-03 in tube of 100 gm Storage Store at 20°-25°C (68° and 77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Temperature].
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Desoximetasone Ointment USP, 0.25% NDC – 72578-095-01 15 gm tube Desoximetasone oinment, 0.25 carton label
Overview
Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11b,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: structured product formula for Desoximetasone
Indications & Usage
Desoximetasone Ointment 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 Ointment USP, 0.25% to the affected skin areas twice daily. Rub in gently.
Warnings & Precautions
WARNINGS Keep out of reach of children.
Contraindications
Desoximetasone ointment, 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 was low (0.3%) for Desoximetasone Ointment USP, 0.25% and consisted of development of comedones at the site of application. To report side effects call Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.
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