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 INFORMATION
    These 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% ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Desoximetasone topical spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.
  • 2 DOSAGE AND ADMINISTRATION
    Apply 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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Topical Spray, 0.25%. Each gram of desoximetasone topical spray contains 2.5 mg of desoximetasone USP in a clear, colorless liquid.
  • 4 CONTRAINDICATIONS
    None
  • 5 WARNINGS AND PRECAUTIONS
    5.1 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 ...
  • 6 ADVERSE REACTIONS
    6.1 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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 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 ...
  • 10 OVERDOSAGE
    Desoximetasone topical spray, 0.25% can be absorbed in sufficient amounts to produce systemic effects. [see Warnings and Precautions (5.1)]
  • 11 DESCRIPTION
    Desoximetasone 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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 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 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 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 ...
  • 14 CLINICAL STUDIES
    Two 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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 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 ...
  • 17 PATIENT COUNSELING INFORMATION
    See 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 ...
  • PATIENT PACKAGE INSERT
    PATIENT 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 ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Desoximetasone 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
  • INGREDIENTS AND APPEARANCE
    Product Information