alclometasone dipropionate

FDA Drug Profile — Alclometasone Dipropionate

alclometasone dipropionate is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Alclometasone Dipropionate. Available dosage form: cream.

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 cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream and 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 cream and ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.