Label: ZIVA BABY WIPES- zinc oxide cloth

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 5, 2023

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  • Active Ingredient:

    Zinc Oxide 0.1%

  • PURPOSE

  • Direction for use

    Peel back the front label or open  the flip top slowly. Pull wipes as needed. Gently cleanse your baby's skin using one or more wipes. Reseal pouch by firmly running thumb over label to close the flip top to prevent moisture loss.

  • Precautions:

    For external use only. Do not apply to irritated or damaged skin. In case of gluteal erythema (redness of skin), contact your doctor or pharmacist. Keep in a cool place away from direct sunlight. Prevent contact with eyes. In case of irritation wash away with water immediately.

  • DOSAGE & ADMINISTRATION

  • Keep out of rech of children

  • SPL UNCLASSIFIED SECTION

    Store below 25°C

  • Ingredients:

    Aqua, Zinc Oxide, Pentylene Glycol and Glyceryl Caprylate / Caprate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Propylene Glycol, Sodium cocoamphoacetate, Disodium cocoamphodiacetate,  Cocamidoproply Betaine, PEG 40 Hydrogenated Castor Oil, Chamomile Extract, PEG-120 Methyl Glucose Dioleate,  Disodium EDTA, Citric Acid.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    ZIVA BABY WIPES 
    zinc oxide cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81450-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81450-005-0180 in 1 PACKAGE12/24/2021
    14.59 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00312/24/2021
    Labeler - Ziva Wetwipes FZCo (559186188)
    Registrant - Dirra USA (117678868)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ziva Wetwipes FZCO559186188manufacture(81450-005)
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