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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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PACKAGE FILES

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Generic Name
MOMETASONE FUROATE, DIMETHICONE
Substance Name
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
Description
11 DESCRIPTION Mometasone Furoate Cream USP, 0.1% contains mometasone furoate for topical 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 Cl 2 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 in a white to off-white 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. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Mometasone Furoate Cream USP, 0.1% is white to off-white in color and supplied in 45-gram (NDC 81877-520-45) tubes; boxes of one. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat.
Indications & Usage
1 INDICATIONS AND USAGE Mometasone Furoate Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. Mometasone Furoate Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥2 years of age. ( 1 )
Dosage and Administration
2 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 established in pediatric patients below 2 years of age; use in this age group is not recommended [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] . Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1) ] . Do not use mometasone furoate cream with occlusive dressings unless directed by a physician. Do not apply mometasone furoate cream in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing. Avoid contact with eyes. Wash hands after each application. Avoid use on the face, groin, or axillae. Mometasone furoate cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use. 1. Apply a thin film to the affected skin areas once daily. ( 2 ) 2. Discontinue therapy when control is achieved. ( 2 ) 3. If no improvement is seen within 2 weeks, reassess diagnosis. ( 2 ) 4. Do not use with occlusive dressings unless directed by a physician. ( 2 )