ANTI MONKEY BUTT DIAPER RASH - zinc oxide and ferric oxide red cream
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.

----------

Drug Facts

Active Ingredients

Zinc Oxide 12.0%

Calamine Powder 2.0%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash
Protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

When using this product

Do not get into eyes

Stop use and ask a doctor if

Condition worsens
Symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control center right away.

Directions

Change wet and soiled diapers promptly
Cleanse the diaper area
Allow to dry
Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other Information

Store at 20° to 27°C (68° to 80°F)

Inactive Ingredients

Allantoin, calendula extract, castor oil, dowicil, fragrance, mineral oil, Peruvian balsam, white petrolatum.

PRINCIPAL DISPLAY PANEL

Baby
Anti Monkey
Butt®
Diaper Rash Cream
with Calamine
Helps Treat and Prevent Diaper Rash
NET WT 3 oz (85g)

PRINCIPAL DISPLAY PANEL
Baby Anti Monkey Butt Diaper Rash Cream

ANTI MONKEY BUTT DIAPER RASH
zinc oxide and ferric oxide red cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:89411-0003
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (ZINC OXIDE)	Zinc Oxide	0.139 g in 1 g
FERRIC OXIDE RED (FERRIC OXIDE RED)	FERRIC OXIDE RED	0.001 g in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN
CALENDULA OFFICINALIS FLOWER
CASTOR OIL
MINERAL OIL
Balsam Peru
PETROLATUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:89411-0003-1	85 g in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2010	04/16/2012

Labeler - DSE Healthcare Solutions, LLC. (603016069)

Establishment
Name	Address	ID/FEI	Operations
Denison Pharmaceuticals, Inc.		001207208	MANUFACTURE

Revised: 05/2010 DSE Healthcare Solutions, LLC.