Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Desoximetasone Ointment USP, 0.25% is supplied in 15 gram tubes (NDC 68462-531-17) and 60 gram tubes (NDC 68462-531-65) 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]. Manufactured by: Glenmark Pharmaceuticals Ltd. Village Kishanpura, Baddi Nalagarh Road District: Solan, Himachal Pradesh – 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkpharma.com/usa September 2014; Package/Label Display Panel NDC 68462-531-65 Desoximetasone Ointment USP, 0.25% For topical use only. Not for oral, ophthalmic, or intravaginal use. desoximetasone-carton
- HOW SUPPLIED Desoximetasone Ointment USP, 0.25% is supplied in 15 gram tubes (NDC 68462-531-17) and 60 gram tubes (NDC 68462-531-65) 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]. Manufactured by: Glenmark Pharmaceuticals Ltd. Village Kishanpura, Baddi Nalagarh Road District: Solan, Himachal Pradesh – 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkpharma.com/usa September 2014
- Package/Label Display Panel NDC 68462-531-65 Desoximetasone Ointment USP, 0.25% For topical use only. Not for oral, ophthalmic, or intravaginal use. desoximetasone-carton
Overview
Desoximetasone ointment 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 ointment USP, 0.25% contains 2.5 mg of desoximetasone USP in an ointment base consisting of fractionated coconut oil 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 376.46. The CAS Registry Number is 382-67-2. The structural formula is: Structure
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 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 Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria In controlled clinical studies the incidence of adverse reactions was low (0.3%) for desoximetasone ointment 0.25 % and consisted of development of comedones at the site of application.
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