BABY ANTI MONKEY BUTT DIAPER RASH- zinc oxide, calamine cream 
Denison Pharmaceuticals, 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 Anit Monkey Butt Diaper Rash

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, mineral oil, Peruvian balsam, white petrolatum

Questions?

Call 1-844-426-8465

BABY ANTI MONKEY BUTT DIAPER RASH (ZINC OXIDE, CALAMINE) CREAM

Label Image
BABY ANTI MONKEY BUTT DIAPER RASH 
zinc oxide, calamine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-8942
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.12 g  in 1 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
CASTOR OIL (UNII: D5340Y2I9G)  
MINERAL OIL (UNII: T5L8T28FGP)  
BALSAM PERU (UNII: 8P5F881OCY)  
PETROLATUM (UNII: 4T6H12BN9U)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-8942-4685 g in 1 TUBE; Type 0: Not a Combination Product01/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/201702/14/2022
Labeler - Denison Pharmaceuticals, LLC. (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC.001207208manufacture(0295-8942)

Revised: 2/2022
 
Denison Pharmaceuticals, LLC.