BABY DIAPER RASH CREAM (ZINC OXIDE) CREAM [DOTERRA INTERNATIONAL, LLC]

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BABY DIAPER RASH CREAM (ZINC OXIDE) CREAM [DOTERRA INTERNATIONAL, LLC]
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NDC 71630-549-60
Set ID 641465a1-0daf-1bb9-e053-2a91aa0ab25d
Category HUMAN OTC DRUG LABEL
Packager doTERRA International, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT

    Zinc Oxide 25%

    Zinc Oxide

  • PURPOSE

    Skin protectant Drug Facts

  • INDICATIONS & USAGE

    Uses

    • Helps treat and prevent diaper rash
    • Protects chafed skin due to diaper rash and
    helps seal out wetness

  • WARNINGS

    For external use only.

    Drug Facts

  • WHEN USING

    When using this product do not get into eyes

  • STOP USE

    DF Diaper CreamStop 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

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

  • OTHER SAFETY INFORMATION

    Other information

    • Store between 20º to 25ºC (68º to 77ºF)
    • Do not use if quality seal is broken

  • INACTIVE INGREDIENT

    Inactive ingredients: Caprylic/Capric Triglyceride, Simmondsia chinensis
    (Jojoba) Seed Oil, Beeswax (Cera Alba),
    Butyrospermum parkii (Shea) Butter, Carthamus
    tinctorius (Safflower) Oleosomes, Water (Aqua),
    Caprylyl Glycol, Lavandula angustifolia (Lavender)
    Oil, Daucus carota sativa (Carrot) Seed Oil,
    Melaleuca alternifolia (Tea Tree) Leaf Oil

    DFP

  • QUESTIONS

    Questions? Call 1-800-411-8151

  • DOSAGE & ADMINISTRATION

    Active ingredient Purpose

    Zinc Oxide 25%...........................Skin Protectant

    Directions

    • Change wet or soiled diapers promptly
    • Cleanse 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

  • Principal Display Panel and Package Label

    doTERRA® baby

    Diaper Rash Cream

    Helps Treat, Soothe, and Prevent Diaper Rash

    Net wt. 2.1 oz/60 g

    PDP

  • INGREDIENTS AND APPEARANCE
    BABY DIAPER RASH CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71630-549
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71630-549-6060 g in 1 TUBE; Type 0: Not a Combination Product05/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/09/2018
    Labeler - doTERRA International, LLC (832274935)
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