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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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:42364-0013
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:42364-0013-0	170 g in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/18/2012

Labeler - DSE Healthcare Solutions, LLC. (603016069)

Establishment
Name	Address	ID/FEI	Operations
PTI Union LLC		807308858	MANUFACTURE

Revised: 04/2012 DSE Healthcare Solutions, LLC.