Label: BABY ANTI MONKEY BUTT DIAPER RASH- zinc oxide, calamine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated December 27, 2017

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  • 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

  • PRINCIPAL DISPLAY PANEL

    Fragrance-Free

    Baby Anti Monkey Butt®
    Diaper Rash Cream
    with Calamine

    Helps Treat and Prevent Diaper Rash

    NET WT 3 oz (85 g)

    Tender Loving Care for Your Baby's Derrière

    Helps Prevent & Treat
    • Diaper Rash • Chafing • Minor Skin Irritations

    Helps Protect from Wetness

    For Products and Information:
    www.antimonkeybutt.com


    Distributed by: Clarion Brands, LLC
    27070 Miles Road, Suite A, Solon, OH 44139
    8942A    ©2015

    Label

    Baby Anti Monkey Butt®
    AML3000025C

  • INGREDIENTS AND APPEARANCE
    BABY ANTI MONKEY BUTT DIAPER RASH  
    zinc oxide, calamine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69693-818
    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:69693-818-0385 g in 1 TUBE; Type 0: Not a Combination Product03/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2016
    Labeler - Clarion Brands, LLC (079742703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(69693-818)
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