hydrocortisone butyrate

FDA Drug Profile — Hydrocortisone Butyrate

Drug Details

Generic Name
hydrocortisone butyrate
Brand Names
Hydrocortisone Butyrate
Application Number
NDA018652
Sponsor
Oceanside Pharmaceuticals
NDC Codes
1
Dosage Forms
OINTMENT
Routes
TOPICAL
Active Ingredients
HYDROCORTISONE BUTYRATE

Indications and Usage

1 INDICATIONS AND USAGE Hydrocortisone Butyrate Cream (lipid), 0.1% is indicated for: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older. Hydrocortisone Butyrate Cream (lipid), 0.1% is a corticosteroid indicated for: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. ( 1 ) The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older. ( 1 )