MOMETASONE FUROATE CREAM

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC USE

DESCRIPTION

Mometasone furoate cream USP, 0.1% contains mometasone furoate, USP for dermatologic use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity.

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.

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 or older, although the safety and efficacy of the drug use for longer than 3 weeks have not been established (See PRECAUTIONS - Pediatric Use). Since safety and efficacy of mometasone furoate cream USP, 0.1% have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended.