Label: MOMETASONE FUROATE lotion

  • NDC Code(s): 21922-072-01, 21922-072-21
  • Packager: Encube Ethicals Private Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 20, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use MOMETASONEFUROATE TOPICAL SOLUTION safely and effectively. See full prescribing information for MOMETASONE FUROATE TOPICAL SOLUTION ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Mometasone furoate topical solution USP, 0.1% (lotion) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in ...
  • 2 DOSAGE AND ADMINISTRATION
    Apply a few drops of mometasone furoate lotion to the affected skin areas once daily and massage lightly until it disappears. Therapy should be discontinued when control is achieved. If no ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Lotion, 0.1%. Each gram of mometasone furoate lotion contains 1 mg of mometasone furoate in a colorless, clear to translucent lotion base.
  • 4 CONTRAINDICATIONS
    Mometasone furoate lotion is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Effects on Endocrine System - Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for ...
  • 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 ...
  • 7 DRUG INTERACTIONS
    No drug-drug interaction studies have been conducted with mometasone furoate lotion.
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, mometasone furoate lotion should be used during ...
  • 10 OVERDOSAGE
    Topically applied mometasone furoate lotion can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].
  • 11 DESCRIPTION
    Mometasone furoate topical solution USP, 0.1% (lotion) contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti inflammatory ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate lotion. Long-term ...
  • 14 CLINICAL STUDIES
    The safety and efficacy of mometasone furoate lotion for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle controlled trials, one in scalp psoriasis and one ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Mometasone furoate topical solution USP, 0.1% (lotion) is colorless, clear to translucent and supplied in 30-mL (27.5 gram) (NDC 21922-072-21) and 60-mL (55 gram) (NDC 21922-072-01) bottles; boxes ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the following: • Use mometasone furoate lotion as directed by the physician. It is for ...
  • PATIENT INFORMATION
    Mometasone Furoat Topical Solution USP, 0.1% (lotion) (moe met' a sone fure' oh ate) Important information: Mometasone furoate lotion is for use on skin only. Do not use Mometasone ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Carton - 30ml - NDC 21922-072-21 - For dermatologic use only. Not for ophthalmic use. Rx Only  - 30ml (27.5g) Carton - 60ml - NDC 21922-072-01 - For dermatologic use only. Not for ophthalmic use ...
  • INGREDIENTS AND APPEARANCE
    Product Information