Anti Monkey Butt Diaper Rash

Dosage form: cream
Ingredients: Zinc Oxide 0.139g in 1g, FERRIC OXIDE RED 0.001g in 1g
Labeler: DSE Healthcare Solutions, LLC.
NDC Code: 42364-0003

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.

Anti Monkey Butt Diaper Rash Cream

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)

ANTI MONKEY BUTT DIAPER RASH  
zinc oxide and ferric oxide red cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42364-0003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (ZINC OXIDE) Zinc Oxide0.139 g  in 1 g
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED0.001 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
CALENDULA OFFICINALIS FLOWER 
CASTOR OIL 
MINERAL OIL 
Balsam Peru 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:42364-0003-185 g in 1 TUBE
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
Denison Pharmaceuticals, Inc.001207208MANUFACTURE(42364-0003)

Revised: 04/2012
 
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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