BABY ANTI MONKEY BUTT DIAPER RASH - zinc oxide and ferric oxide red powder 
DSE Healthcare Solutions, LLC.

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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)

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

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 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: 05/2010DSE Healthcare Solutions, LLC.