Drug Catalog - Product Detail
MOMETASONE FUROATE CREAM CRM 0.001 45GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0257-42 | PADAGIS | 45 | 0.1% | CREAM |
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Description
DESCRIPTION Mometasone Furoate Cream USP, 0.1%, contains mometasone furoate, USP for dermatologic use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9α,21-dichloro-11β, 17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27 H 30 C I2 O 6 , a molecular weight of 521.4 and the following structural formula: Mometasone furoate is a white, to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of Mometasone Furoate Cream USP, 0.1%, contains: 1 mg mometasone furoate, USP in a cream base of aluminum starch octenylsuccinate, ceteareth-20, phosphoric acid, propylene glycol, propylene glycol stearate, purified water, stearyl alcohol, titanium dioxide, white petrolatum and white wax. ChemStruc
How Supplied
HOW SUPPLIED Mometasone Furoate Cream USP, 0.1%, is supplied in 15 g tubes - NDC 45802-257-35 and 45 g tubes - NDC 45802-257-42; boxes of one. Store Mometasone Furoate Cream at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].
Indications & Usage
INDICATIONS AND USAGE Mometasone Furoate Cream USP, 0.1%, is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Mometasone Furoate Cream USP, 0.1%, may be used in pediatric patients 2 years of age of older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS - Pediatric Use section). Since safety and efficacy of mometasone furoate cream have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended.
Dosage and Administration
DOSAGE AND ADMINISTRATION Apply a thin film of mometasone furoate cream to the affected skin areas once daily. Mometasone furoate cream may be used in pediatric patients 2 years of age or older. Since safety and efficacy of mometasone furoate cream have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended (see PRECAUTIONS - Pediatric Use section). As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Safety and efficacy of mometasone furoate cream in pediatric patients for more than 3 weeks of use have not been established. Mometasone furoate cream should not be used with occlusive dressings unless directed by a physician. Mometasone furoate cream should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.