NDC Code(s) : 42364-0003-1
Packager : DSE Healthcare Solutions, LLC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Anti Monkey Butt Diaper Rash Zinc Oxide and Ferric Oxide Red CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42364-0003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc Oxide(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		Zinc Oxide0.139 g in 1 g
FERRIC OXIDE RED(UNII: 1K09F3G675)
(FERRIC OXIDE RED - UNII:1K09F3G675) 		FERRIC OXIDE RED0.001 g in 1 g
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN(UNII: 344S277G0Z)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
CASTOR OIL(UNII: D5340Y2I9G)
MINERAL OIL(UNII: T5L8T28FGP)
Balsam Peru(UNII: 8P5F881OCY)
PETROLATUM(UNII: 4T6H12BN9U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42364-0003-185 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 04/18/2012

PRINCIPAL DISPLAY PANEL

Baby
Anti Monkey
Butt®
Diaper Rash Cream
with Calamine
Helps Treat and Prevent Diaper Rash
NET WT 3 oz (85g)

PRINCIPAL DISPLAY PANEL Baby Anti Monkey Butt Diaper Rash Cream