NDC Code(s) : 68220-144-10
Packager : Alaven Pharmaceutical LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Epifoamhydrocortisone acetate and pramoxine hydrochloride AEROSOL, FOAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68220-144
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
hydrocortisone acetate(UNII: 3X7931PO74)
(hydrocortisone - UNII:WI4X0X7BPJ) 		hydrocortisone100 mg in 10 g
pramoxine hydrochloride(UNII: 88AYB867L5)
(pramoxine - UNII:068X84E056) 		pramoxine100 mg in 10 g
Inactive Ingredients
Ingredient Name Strength
propylene glycol(UNII: 6DC9Q167V3)
cetyl alcohol(UNII: 936JST6JCN)
glyceryl monostearate(UNII: 230OU9XXE4)
laureth-23(UNII: N72LMW566G)
polyoxyl 40 stearate(UNII: 13A4J4NH9I)
methylparaben(UNII: A2I8C7HI9T)
propylparaben(UNII: Z8IX2SC1OH)
trolamine(UNII: 9O3K93S3TK)
water(UNII: 059QF0KO0R)
isobutane(UNII: BXR49TP611)
propane(UNII: T75W9911L6)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68220-144-101 in 1 CARTON
110 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086457 12/19/1979

PRINCIPAL DISPLAY PANEL

NDC 68220-144-10
STORE UPRIGHT

epifoam®
(hydrocortisone acetate 1% and
pramoxine hydrochloride 1%)

topical aerosol

Rx Only

ALAVEN®
PHARMACEUTICAL LLC

10 g net wt

Principal Display Panel - 10 g Carton

PRINCIPAL DISPLAY PANEL

NDC 68220-144-10
STORE UPRIGHT

10 g net wt

epifoam®
(hydrocortisone acetate 1% and
pramoxine hydrochloride 1%)

topical aerosol

Rx Only

HOLD UPRIGHT TO DISPENSE

WARNINGS: 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).

Principal Display Panel - 10 g Label