hydrocortisone acetate

FDA Drug Profile — Hemmorex-HC, Cortifoam, Poli-A, HYDROCORTISONE ACETATE

Drug Details

Generic Name
hydrocortisone acetate
Brand Names
Hemmorex-HC, Cortifoam, Poli-A, HYDROCORTISONE ACETATE
Application Number
NDA017351
Sponsor
Laser Pharmaceuticals, LLC
NDC Codes
6
Dosage Forms
SUPPOSITORY, AEROSOL, FOAM, OINTMENT, POWDER
Routes
RECTAL, TOPICAL
Active Ingredients
HYDROCORTISONE ACETATE

Indications and Usage

INDICATIONS: Based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: “Possibly” Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); monliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation.