NDC Code(s) : 69693-818-03
Packager : Clarion Brands, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BABY ANTI MONKEY BUTT DIAPER RASH ZINC OXIDE, CALAMINE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69693-818
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 Oxide0.12 g in 1 g
Ferric Oxide Red(UNII: 1K09F3G675)
(Ferric Oxide Red - UNII:1K09F3G675) 		Ferric Oxide Red0.02 g in 1 g
Inactive Ingredients
Ingredient Name Strength
Allantoin(UNII: 344S277G0Z)
Calendula Officinalis Seed Oil(UNII: 9JS8DS42SV)
Castor Oil(UNII: D5340Y2I9G)
Mineral Oil(UNII: T5L8T28FGP)
Balsam Peru(UNII: 8P5F881OCY)
Petrolatum(UNII: 4T6H12BN9U)
Calendula Officinalis Flower(UNII: P0M7O4Y7YD)
Glycerin(UNII: PDC6A3C0OX)
Water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69693-818-0385 g in 1 TUBE Type 0: Not a Combination Product03/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M016 03/01/2016

LABELER - Clarion Brands, LLC(079742703)

PRINCIPAL DISPLAY PANEL

Fragrance-Free

Baby Anti Monkey Butt®
Diaper Rash Cream
with Calamine

Helps Treat and Prevent Diaper Rash

NET WT 3 oz (85 g)

Tender Loving Care for Your Baby's Derrière

Helps Prevent & Treat
• Diaper Rash • Chafing • Minor Skin Irritations

Helps Protect from Wetness

For Products and Information:
www.antimonkeybutt.com


Distributed by: Clarion Brands, LLC
27070 Miles Road, Suite A, Solon, OH 44139
8942A    ©2015

Baby Anti Monkey Butt®
AML3000025C