pramoxine hydrochloride and hydrocortisone acetate

FDA Drug Profile — EPIFOAM

Drug Details

Generic Name
pramoxine hydrochloride and hydrocortisone acetate
Brand Names
EPIFOAM
Application Number
ANDA086457
Sponsor
Viatris Specialty LLC
NDC Codes
1
Dosage Forms
AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients
HYDROCORTISONE ACETATE, PRAMOXINE HYDROCHLORIDE

Indications and Usage

INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Warnings

WARNINGS Not for prolonged use. If redness, pain, irritation or swelling persists, discontinue use and consult a physician. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). Keep this and all medicines out of the reach of children.