Baby Anti Monkey Butt Diaper Rash

Dosage form: powder
Ingredients: ZINC OXIDE 0.076g in 1g, FERRIC OXIDE RED 0.004g in 1g
Labeler: DSE Healthcare Solutions, LLC.
NDC Code: 42364-0013

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.

Baby Anti Monkey Butt Diaper Rash Powder

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 do not get better within 7 days

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact 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 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.

Inactive Ingredients

Cornstarch, fragrance, tricalciumphosphate

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)

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.076 g  in 1 g
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED0.004 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
TRICALCIUM PHOSPHATE 
Packaging
#Item CodePackage Description
1NDC:42364-0013-0170 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/18/2012
Labeler - DSE Healthcare Solutions, LLC. (603016069)
Establishment
NameAddressID/FEIOperations
PTI Union LLC807308858MANUFACTURE(42364-0013)
Establishment
NameAddressID/FEIOperations
Thornton Industries, Inc.614259299MANUFACTURE(42364-0013)

Revised: 07/2012
 
DSE Healthcare Solutions, LLC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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