BABY ANTI MONKEY BUTT DIAPER RASH (ZINC OXIDE, FERRIC OXIDE RED) POWDER [CLARION BRANDS, LLC]

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BABY ANTI MONKEY BUTT DIAPER RASH (ZINC OXIDE, FERRIC OXIDE RED) POWDER [CLARION BRANDS, LLC]
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NDC 69693-815-06
Set ID 035ff2f0-a5ca-7f0e-a4ff-01be40187c74
Category HUMAN OTC DRUG LABEL
Packager Clarion Brands, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active Ingredients

    Calamine Powder 8.0%

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin and minor skin irritations due to diaper rash
    • helps protect from wetness
  • Warnings

    For external use only

  • When using this product

    • avoid contact with eyes
    • do not use on broken skin
    • keep powder away from child's face to avoid inhalation, which can cause breathing problems
  • 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

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years and older: apply freely up to 3 or 4 times daily. For best results, dry skin thoroughly before applying.
    • babies: change wet and soiled diaper promptly, cleanse the diaper area and allow to dry. Apply powder liberally as often as necessary, with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged. Apply powder close to the body away from child's face. Carefully shake the powder into the diaper or into the hand and apply to the diaper area.
  • Inactive ingredients

    cornstarch, fragrance, tricalciumphosphate

  • Questions?

    Call 1-844-426-8465

  • PRINCIPAL DISPLAY PANEL

    Baby Anti Monkey Butt®
    Diaper Rash Powder
    with Calamine

    Talc Free!

    Helps Treat and Prevent Diaper Rash

    NET WT 6 oz (170 g)

    Please recycle

    Tender Loving Care for Your Baby's Derrière

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

    Helps Protect from Wetness

    Sold by weight not by volume.
    Some settling will occur.

    For Products and Information:
    www.antimonkeybutt.com


    Distributed by: Clarion Brands, LLC
    27070 Miles Road, Suite A, Solon, OH 44139
    AML2000025C    ©2015

    Label

    Baby Anti Monkey Butt®
    AML3000025C

    Top Label
  • INGREDIENTS AND APPEARANCE
    BABY ANTI MONKEY BUTT DIAPER RASH  
    zinc oxide, ferric oxide red powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69693-815
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.076 g  in 1 g
    Ferric Oxide Red (UNII: 1K09F3G675) (Ferric Oxide Red - UNII:1K09F3G675) Ferric Oxide Red0.004 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Starch, Corn (UNII: O8232NY3SJ)  
    Tricalcium Phosphate (UNII: K4C08XP666)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69693-815-06170 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2016
    Labeler - Clarion Brands, LLC (079742703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thornton Industries, Inc.614259299MANUFACTURE(69693-815)
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