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Name:Baby Anti Monkey Butt Diaper Rash
Manufacturer:Dse Healthcare Solutions, Llc.
Category:Over-the-counter (OTC) Marketed Drugs


Baby Anti Monkey Butt Diaper Rash Powder

BABY ANTI MONKEY BUTT DIAPER RASH - zinc oxide and ferric oxide red 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

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)
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 Type HUMAN OTC DRUG Item Code (Source) NDC:89411-0013
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.076 g  in 1 g
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED 0.004 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
TRICALCIUM PHOSPHATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:89411-0013-0 170 g in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 05/01/2010

Labeler - DSE Healthcare Solutions, LLC. (603016069)

Revised: 05/2010 DSE Healthcare Solutions, LLC.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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