Label: THINKBABY DIAPER RASH- zinc oxide 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 January 23, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    NON NANO ZINC OXIDE 14%

  • 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 in 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 a 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 any time exposure to wet diapers may be prolonged.
  • Contact information

    Info@GOthinkbaby.com • Thinkbaby,3112 Windsor Rd, Austin, Texas 78703 • 877.446.1616 • Protect product from heat

  • INGREDIENTS

    HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL 1 (1), RICINUS COMMUNIS (CASTOR) SEED OIL (1),CERA ALBA (BEESWAX) 1 (1), COCOS NUCIFERA (COCONUT) OIL 1 (1), SIMMONDSIA CHINENSIS (JOJOBA) OIL 1 (1), BUTYROSPERMUM PARKII (SHEA) BUTTER 1 (1), TOCOPHEROL (1)

    1
    CERTIFIED ORGANIC INGREDIENT(S)natural, mineral based formula
  • PRINCIPAL DISPLAY PANEL - 89 ml Tube Label

    DIAPER RASH
    OINTMENT

    Helps Prevent and Treat Diaper Rash

    thinkbaby™

    SAFER PRODUCTS FOR HEALTHIER BABIES

    natural, mineral based formula

    3 fl oz • 89ml

    The Solution for
    Diaper Rash

    PRINCIPAL DISPLAY PANEL - 89 ml Tube Label
  • INGREDIENTS AND APPEARANCE
    THINKBABY   DIAPER RASH
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60781-2018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE140 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60781-2018-189 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34701/01/2018
    Labeler - thinkOperations,LLC (808883636)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(60781-2018)
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