betamethasone valerate

FDA Drug Profile — Betamethasone Valerate

Drug Details

Generic Name
betamethasone valerate
Brand Names
Betamethasone Valerate
Application Number
NDA018861
Sponsor
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
NDC Codes
7
Dosage Forms
CREAM, OINTMENT, POWDER, LOTION
Routes
TOPICAL
Active Ingredients
BETAMETHASONE VALERATE

Indications and Usage

INDICATIONS AND USAGE Betamethasone valerate foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.

Warnings

WARNING FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep out of reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C). Manufactured for: Xiromed, LLC. Florham Park, NJ 07932 Made in Spain For additional information: 844-XIROMED (844-947-6633) Or visit www.xiromed.com Revised: November 2018 PI-141-01