BABY ANTI MONKEY BUTT DIAPER RASH- ferric oxide red and zinc oxide powder 
DSE Healthcare Solutions, 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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Baby Anti Monkey Butt Diaper Rash Powder

Drug Facts

<content styleCode="bold italics">Active Ingredients</content>Active Ingredients

Calamine Powder 8.0%                                          

<content styleCode="bold italics">Purpose</content>Purpose

Skin Protectant

<content styleCode="bold italics">Uses</content>Uses

  • Helps treat and prevent diaper rash
  • Protects chafed skin and minor skin irritations due to diaper rash
  • Helps protect from wetness

<content styleCode="bold italics">Warnings</content>Warnings

For external use only

<content styleCode="bold">When using this product</content>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

<content styleCode="bold">Stop use and ask a doctor if</content>Stop use and ask a doctor if

  • Condition worsens
  • Symptoms do not get better within 7 days

<content styleCode="bold">Keep out of reach of children. </content>Keep out of reach of children.

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

<content styleCode="bold italics">Directions</content>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 diaper may be prolonged. Apply powder close to the body away from the child’s face. Carefully shake the powder into the diaper or into the hand and apply to the diaper area.

<content styleCode="bold italics">Inactive Ingredients</content>Inactive Ingredients

Cornstarch, fragrance, tricalciumphosphate

<content styleCode="bold">PRINCIPAL DISPLAY PANEL</content>PRINCIPAL DISPLAY PANEL

Tender Loving Care for
Your Baby’s Derrière
Helps Prevent & Treat
Diaper Rash       Chafing
Minor Skin Irritations
Helps Protect from Wetness
Baby
Anti Monkey
Butt®
Diaper Rash Powder
with Calamine
Helps Treat and Prevent Diaper Rash
NET WT 6oz (170g)
PRINCIPAL DISPLAY PANEL
Baby Anti Monkey Butt Diaper Rash Powder

BABY ANTI MONKEY BUTT DIAPER RASH 
ferric oxide red and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42364-0013
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:42364-0013-0170 g in 1 BOTTLE; Type 0: Not a Combination Product04/18/201210/14/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/18/201210/14/2014
Labeler - DSE Healthcare Solutions, LLC. (603016069)
Establishment
NameAddressID/FEIBusiness Operations
PTI Union LLC807308858MANUFACTURE(42364-0013)
Establishment
NameAddressID/FEIBusiness Operations
Thornton Industries, Inc.614259299MANUFACTURE(42364-0013)

Revised: 12/2018
 
DSE Healthcare Solutions, LLC.