alclometasone dipropionate

FDA Drug Profile — Alclometasone Dipropionate

Drug Details

Generic Name
alclometasone dipropionate
Brand Names
Alclometasone Dipropionate
Application Number
ANDA076973
Sponsor
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
ALCLOMETASONE DIPROPIONATE

Indications and Usage

INDICATIONS AND USAGE Alclometasone Dipropionate Ointment USP, 0.05% is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use ). Since the safety and efficacy of alclometasone dipropionate ointment has not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.