BABY ANTI MONKEY BUTT DIAPER RASH- zinc oxide, ferric oxide red powder 
Clarion Brands, LLC

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.

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Drug Facts

Active Ingredients

Calamine Powder 8.0%

Purpose

Skin Protectant

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin and minor skin irritations due to diaper rash
  • helps protect from wetness

Warnings

For external use only

When using this product

  • avoid contact with eyes
  • do not use on broken skin
  • keep powder away from child's face to avoid inhalation, which can cause breathing problems

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 2 years and older: apply freely up to 3 or 4 times daily. For best results, dry skin thoroughly before applying.
  • babies: change wet and soiled diaper promptly, cleanse the diaper area and allow to dry. Apply powder liberally as often as necessary, with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged. Apply powder close to the body away from child's face. Carefully shake the powder into the diaper or into the hand and apply to the diaper area.

Inactive ingredients

cornstarch, fragrance, tricalciumphosphate

Questions?

Call 1-844-426-8465

PRINCIPAL DISPLAY PANEL

Baby Anti Monkey Butt®
Diaper Rash Powder
with Calamine

Talc Free!

Helps Treat and Prevent Diaper Rash

NET WT 6 oz (170 g)

Please recycle

Tender Loving Care for Your Baby's Derrière

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

Helps Protect from Wetness

Sold by weight not by volume.
Some settling will occur.

For Products and Information:
www.antimonkeybutt.com


Distributed by: Clarion Brands, LLC
27070 Miles Road, Suite A, Solon, OH 44139
AML2000025C    ©2015

Label

Baby Anti Monkey Butt®
AML3000025C

Top Label
BABY ANTI MONKEY BUTT DIAPER RASH 
zinc oxide, ferric oxide red powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69693-815
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.076 g  in 1 g
Ferric Oxide Red (UNII: 1K09F3G675) (Ferric Oxide Red - UNII:1K09F3G675) Ferric Oxide Red0.004 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Starch, Corn (UNII: O8232NY3SJ)  
Tricalcium Phosphate (UNII: K4C08XP666)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69693-815-06170 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/201612/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/201612/13/2022
Labeler - Clarion Brands, LLC (079742703)
Establishment
NameAddressID/FEIBusiness Operations
Thornton Industries, Inc.614259299MANUFACTURE(69693-815)

Revised: 12/2022
Document Id: bbe5d1fa-f3a7-4f54-bc3a-fe1d1b03f328
Set id: 035ff2f0-a5ca-7f0e-a4ff-01be40187c74
Version: 6
Effective Time: 20221227
 
Clarion Brands, LLC