Label: ZOEY NATURALS DIAPER 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 July 22, 2019

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  • Drug Facts

  • Active ingredient

    Zinc Oxide 15%

  • Purpose

    Skin Protectant

  • Uses

    • ZOEY Naturals DIAPER CREAM helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness.

  • Warnings

    For external use only.

    When using this product

    • do not get into eyes.

    • rinse with water to remove.

    Stop use and ask doctor if • condition worsens • rash or irritation develops and lasts more than 7 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 diaper area and allow to dry • Apply cream liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

  • Other information

    • Will stain clothing

    • Store at room temperature

  • Inactive ingredients

    (INCI): Cocoa nucifera (coconut) oil, butyrospermum parkii (shea) butter, helianthus annuus (sunflower) seed oil, cera alba (beeswax), ricinus communis (castor) seed oil, carthamus tinctorius (safflower) seed oil, vitis vinifera (grape) seed oil, maranta arundinacea (arrowroot) root powder, theobroma cacao (cocoa) seed butter, mangifera indica (mango) seed butter, persea gratissima (avocado) oil, kaolin clay, tocopheryl acetate (vitamin E).

  • Questions?

    Call us! 800-848-8498

  • SPL UNCLASSIFIED SECTION

    Fragrance Free

    SKIN PROTECTANT

    HYPOALLERGENIC, NO HARSH CHEMICALS, THERAPEUTIC RELIEF, ZINC BLEND

    made for babies

    loved by mamas

    www.Zoey-Naturals.com

    Manufactured by: Absolutely Natural, Inc.

    640 Atlantis Road, Melbourne, FL 32904

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ZOEY NATURALS DIAPER CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70793-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    KAOLIN (UNII: 24H4NWX5CO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70793-010-341 in 1 BOX03/09/2020
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/09/2020
    Labeler - Absolutely Natural (166425202)
    Establishment
    NameAddressID/FEIBusiness Operations
    Absolutely Natural166425202manufacture(70793-010)
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