NDC Code(s) : 0187-5183-60
Packager : Valeant Pharmaceuticals North America LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dermatopprednicarbate OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-5183
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
prednicarbate(UNII: V901LV1K7D)
(prednicarbate - UNII:V901LV1K7D) 		prednicarbate1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
petrolatum(UNII: 4T6H12BN9U)
octyldodecanol(UNII: 461N1O614Y)
GLYCERYL OLEATE(UNII: 4PC054V79P)
propylene glycol(UNII: 6DC9Q167V3)
citric acid monohydrate(UNII: 2968PHW8QP)
propyl gallate(UNII: 8D4SNN7V92)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0187-5183-6060 g in 1 TUBE Type 0: Not a Combination Product23/06/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019568 06/23/2014 04/01/2017

PRINCIPAL DISPLAY PANEL

NDC 0187-5183-60

Rx ONLY

DERMATOP® Ointment
prednicarbate ointment 0.1%

FOR DERMATOLOGIC USE ONLY — NOT FOR USE IN EYES

One 60 g Tube

VALEANT
Pharmaceuticals North America LLC

Principal Display Panel - 60g Tube Carton