Label: BABY ANTI MONKEY BUTT DIAPER RASH- zinc oxide, calamine cream
- NDC Code(s): 69693-818-03
- Packager: Clarion Brands, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 27, 2017
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- Active Ingredients
- Purpose
- Uses
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- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
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- Inactive ingredients
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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
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INGREDIENTS AND APPEARANCE
BABY ANTI MONKEY BUTT DIAPER RASH
zinc oxide, calamine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69693-818 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.12 g in 1 g Ferric Oxide Red (UNII: 1K09F3G675) (Ferric Oxide Red - UNII:1K09F3G675) Ferric Oxide Red 0.02 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 1 NDC:69693-818-03 85 g in 1 TUBE; Type 0: Not a Combination Product 03/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/01/2016 Labeler - Clarion Brands, LLC (079742703) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals, LLC 001207208 manufacture(69693-818)