Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Desoximetasone Ointment USP, 0.25% is supplied as follows: 15 gram tube (NDC 45802- 496 -14) 60 gram tube (NDC 45802- 496 -96); PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- 15 g CARTON NDC 45802-496-14 Rx Only Desoximetasone Ointment USP, 0.25% For Topical Use Only. Not For Oral, Ophthalmic, or Intravaginal Use. NET WT 15 g Keep this and all medications out of the reach of children. The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. carton serialization-template
- HOW SUPPLIED Desoximetasone Ointment USP, 0.25% is supplied as follows: 15 gram tube (NDC 45802- 496 -14) 60 gram tube (NDC 45802- 496 -96)
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- 15 g CARTON NDC 45802-496-14 Rx Only Desoximetasone Ointment USP, 0.25% For Topical Use Only. Not For Oral, Ophthalmic, or Intravaginal Use. NET WT 15 g Keep this and all medications out of the reach of children. The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. carton serialization-template
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-,(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: Image 1
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 USP, 0.25% and consisted of development of comedones at the site of application. To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Storage & Handling
Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
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