NDC Code(s) : 68220-142-10
Packager : Alaven Pharmaceutical LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Proctofoam hydrocortisone acetate and pramoxine hydrochloride AEROSOL, FOAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68220-142
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE(UNII: 3X7931PO74)
(HYDROCORTISONE - UNII:WI4X0X7BPJ) 		HYDROCORTISONE ACETATE100 mg in 10 g
PRAMOXINE HYDROCHLORIDE(UNII: 88AYB867L5)
(PRAMOXINE - UNII:068X84E056) 		PRAMOXINE HYDROCHLORIDE100 mg in 10 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
TROLAMINE(UNII: 9O3K93S3TK)
ISOBUTANE(UNII: BXR49TP611)
PROPANE(UNII: T75W9911L6)
STEARETH-10(UNII: FD0913P475)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYSORBATE 60(UNII: CAL22UVI4M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68220-142-101 in 1 CARTON
110 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086195 07/26/1978

PRINCIPAL DISPLAY PANEL

NDC 68220-142-10
STORE UPRIGHT

10 g net wt

proctofoam® HC
(hydrocortisone acetate 1% and
pramoxine hydrochloride 1%)

topical aerosol

Rx Only

HOLD UPRIGHT TO
DISPENSE

SHAKE WELL BEFORE
USE

Principal Display Panel - 10 g Label