Label: DESOXIMETASONE spray
- NDC Code(s): 68180-944-11, 68180-944-22, 68180-944-33
- Packager: Lupin Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 20, 2025
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use Desoximetasone Topical Spray, 0.25% safely and effectively. See full prescribing information for Desoximetasone Topical Spray, 0.25% ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGEDesoximetasone topical spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.
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2 DOSAGE AND ADMINISTRATIONApply desoximetasone topical spray, 0.25% as a thin film to the affected skin areas twice daily. Rub in gently. Do not bandage or otherwise cover or wrap the treated skin unless directed by ...
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3 DOSAGE FORMS AND STRENGTHSTopical Spray, 0.25%. Each gram of desoximetasone topical spray contains 2.5 mg of desoximetasone USP in a clear, colorless liquid.
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4 CONTRAINDICATIONSNone
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5 WARNINGS AND PRECAUTIONS5.1 Effect on Endocrine System - Desoximetasone topical spray, 0.25% is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Systemic ...
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6 ADVERSE REACTIONS6.1 Clinical Trials Experience - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - There are no available data on desoximetasone use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal ...
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10 OVERDOSAGEDesoximetasone topical spray, 0.25% can be absorbed in sufficient amounts to produce systemic effects. [see Warnings and Precautions (5.1)]
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11 DESCRIPTIONDesoximetasone topical spray, 0.25% for dermatologic use contains desoximetasone as the active ingredient. Desoximetasone is a corticosteroid with the chemical name of pregna-1, 4-diene-3 ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Corticosteroids play a role in cellular signaling, immune function, inflammation and protein regulation; however, the precise mechanism of action in psoriasis is ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term animal studies have not been performed to evaluate the carcinogenic potential of desoximetasone topical spray, 0.25%. In ...
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14 CLINICAL STUDIESTwo multi-center, randomized, double-blind, vehicle- controlled clinical trials were conducted in 239 subjects aged 18 years and older with moderate to severe plaque psoriasis of the body. In ...
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16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied/Storage - Desoximetasone topical spray, 0.25% is a clear, colorless liquid supplied in white, opaque bottles with white, opaque screw caps in the following sizes: 30 mL (NDC ...
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17 PATIENT COUNSELING INFORMATIONSee FDA-approved patient labeling (Patient Information and Instructions for Use) Inform patients of the following: Use this medication as directed by the physician. Do not use this ...
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PATIENT PACKAGE INSERTPATIENT INFORMATION - Desoximetasone Topical Spray, 0.25% (des-OX-i-MET-a-sone) Important information: Desoximetasone topical spray, 0.25% is for use on skin (topical) only . Do not ...
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELDesoximetasone Topical Spray, 0.25% 100 mL Bottle Carton - NDC 68180-944-33 - Rx only - For Topical Use Only - Not For Oral, Ophthalmic, or Intravaginal Use
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INGREDIENTS AND APPEARANCEProduct Information