EARTH BABY DIAPER RASH CREAM (ZINC OXIDE) CREAM [EARTH BABY, INC]

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EARTH BABY DIAPER RASH CREAM (ZINC OXIDE) CREAM [EARTH BABY, INC]
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NDC 62588-904-02
Set ID 42c5cf9a-0a35-5681-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Earth Baby, Inc
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT

    Active Ingredient
    Zinc Oxide 40%

  • PURPOSE


    Skin Protectant

  • WARNINGS

    Warnings
    For external use only.

  • WHEN USING

    When using this product Do not get into eyes

  • STOP USE

    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

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

  • DOSAGE & ADMINISTRATION

    Directions
    Change diaper promptly.
    Clean diaper area, allow to dry
    Apply a generous amount of creamwith each diaper change and before bedtime.

  • OTHER SAFETY INFORMATION

    Other information
    Store at 20° - 25°C (68° to 77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Avena Sativa (Oat) Kernel Protein, Aloe Barbadensis Leaf Juice*, Aqua/Water, Beeswax, Canola Oil, Carthamus Tinctorius (Safflower) Oleosomes*, Caryodendron Orinocense (Kahai) Seed Oil, Cucurbita Pepo (Pumpkin) Extract, Glycerin, Lavandula Intermedia (Lavender) Flower/Leaf/Stem Extract*, Locinera Japonica (Honeysuckle) Flower Extract, Lonicera Caprifolium (Honeysuckle) Extract, Parfum/Natural Fragrance, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hyaluronate, Tocopheryl Acetate (Vitamin E), Zea Mays (Corn) Starch.

  • INDICATIONS & USAGE

    Helps protect against diaper rash and irritation.

  • PRINCIPAL DISPLAY PANEL

    DRC

  • INGREDIENTS AND APPEARANCE
    EARTH BABY DIAPER RASH CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62588-904
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    CARYODENDRON ORINOCENSE WHOLE (UNII: J2T2D81BHU)  
    CUCURBITA PEPO WHOLE (UNII: 48V44WX64I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAVANDULA X INTERMEDIA WHOLE (UNII: 9Q3NSN290F)  
    LONICERA CAPRIFOLIUM WHOLE (UNII: 4F67A99YTF)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    JOJOBA OIL (UNII: 724GKU717M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62588-904-021 in 1 BOX02/01/201912/31/2022
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/201912/31/2024
    Labeler - Earth Baby, Inc (079298651)
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