Label: VITABATH BABY SOOTHING RELIEF 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 June 13, 2019

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  • Active Ingredients

    Zinc Oxide 14% w/w

  • Purpose

    Skin protectant

  • Uses

    Uses: •helps treat and prevent diaper rash •protects
    chafed skin due to diaper rash •helps seal out wetness

  • Warnings

    For external use only.

    When using this product •avoid contact with eyes

  • WHEN USING

    When using this product •avoid contact with eyes

  • STOP USE

    Stop use and ask a doctor if •condition worsens or
    does not improve within 7 days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical
    help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Change wet or soiled diapers promptly.
    Clean the diaper area and 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.

  • OTHER SAFETY INFORMATION

    Other Information: •Remove quality seal. •Do not use if
    quality seal is broken.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Helianthus Annuus (Sunflower)
    Seed Oil, Beeswax white, Ricinus Communis (Castor)
    Seed Oil, Butyrospermum Parkii (Shea) Butter, Cocos
    Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit
    Oil, Tocopherol, Salvia Sclarea (Clary) Oil, Simmondsia
    Chinensis (Jojoba) Seed Oil, Vitis Vinifera (Grape)
    Seed Oil, Avena Sativa (Oat) Kernel Oil, Calophyllum
    Inophyllum Seed Oil.

  • QUESTIONS

    Questions? Call toll-free 1-888-673-3377

  • PRINCIPAL DISPLAY PANEL

    Tube Label

  • INGREDIENTS AND APPEARANCE
    VITABATH BABY SOOTHING RELIEF DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73172-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TAMANU OIL (UNII: JT3LVK84A1)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73172-004-01113 g in 1 TUBE; Type 0: Not a Combination Product06/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/13/2019
    Labeler - Vitabath Inc. (203461637)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canadian Custom Packaging Comapany207062514manufacture(73172-004)
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