Label: EARTH BABY DIAPER RASH CREAM- 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 March 22, 2021

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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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