Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Topicort ® (desoximetasone ointment USP) 0.05% is supplied in: 15 gram tubes (NDC 51672-5263-1), 30 gram tubes (NDC 51672-5263-2), 60 gram tubes (NDC 51672-5263-3) and 100 gram tubes (NDC 51672-5263-7). 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]; PRINCIPAL DISPLAY PANEL - 15 g Tube Carton NDC 51672-5263-1 15 g Rx only 0.05% OINTMENT Topicort ® Desoximetasone Ointment USP, 0.05% FOR TOPICAL USE ONLY. NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE. Keep this and all medications out of the reach of children. TaroPharma ® PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
- HOW SUPPLIED Topicort ® (desoximetasone ointment USP) 0.05% is supplied in: 15 gram tubes (NDC 51672-5263-1), 30 gram tubes (NDC 51672-5263-2), 60 gram tubes (NDC 51672-5263-3) and 100 gram tubes (NDC 51672-5263-7). 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]
- PRINCIPAL DISPLAY PANEL - 15 g Tube Carton NDC 51672-5263-1 15 g Rx only 0.05% OINTMENT Topicort ® Desoximetasone Ointment USP, 0.05% FOR TOPICAL USE ONLY. NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE. Keep this and all medications out of the reach of children. TaroPharma ® PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
Overview
Topicort ® (desoximetasone ointment USP) 0.05% 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 Topicort ® (desoximetasone ointment USP) 0.05% contains 0.5 mg of desoximetasone in an ointment base consisting of mineral oil 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: Chemical Structure
Indications & Usage
Topicort ® (desoximetasone ointment USP) 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Apply a thin film of Topicort ® (desoximetasone ointment USP) 0.05% to the affected skin areas twice daily. Rub in gently.
Warnings & Precautions
WARNINGS 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 (0.2%) for Topicort ® (desoximetasone ointment USP) 0.05% and included mild burning sensation at the site of application.
Storage & Handling
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]
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