BABY ANTI MONKEY BUTT DIAPER RASH (ZINC OXIDE, CALAMINE) CREAM [CLARION BRANDS, LLC]

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BABY ANTI MONKEY BUTT DIAPER RASH (ZINC OXIDE, CALAMINE) CREAM [CLARION BRANDS, LLC]
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NDC 69693-818-03
Set ID e4424d74-f89c-5943-42e8-bf3a38e68619
Category HUMAN OTC DRUG LABEL
Packager Clarion Brands, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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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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