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 INFORMATIONThese 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 ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGEMometasone 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 ...
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2 DOSAGE AND ADMINISTRATIONApply 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 ...
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3 DOSAGE FORMS AND STRENGTHSLotion, 0.1%. Each gram of mometasone furoate lotion contains 1 mg of mometasone furoate in a colorless, clear to translucent lotion base.
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4 CONTRAINDICATIONSMometasone furoate lotion is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
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5 WARNINGS AND PRECAUTIONS5.1 Effects on Endocrine System - Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for ...
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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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7 DRUG INTERACTIONSNo drug-drug interaction studies have been conducted with mometasone furoate lotion.
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8 USE IN SPECIFIC POPULATIONS8.1 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 ...
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10 OVERDOSAGETopically applied mometasone furoate lotion can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].
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11 DESCRIPTIONMometasone furoate topical solution USP, 0.1% (lotion) contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti inflammatory ...
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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 mometasone furoate lotion. Long-term ...
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14 CLINICAL STUDIESThe 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 ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGMometasone 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 ...
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17 PATIENT COUNSELING INFORMATIONAdvise 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 ...
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PATIENT INFORMATIONMometasone 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 ...
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELCarton - 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 ...
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INGREDIENTS AND APPEARANCEProduct Information