Label: ZIVA WATER WIPES- benzalkonium chloride cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 23, 2021

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  • Active Ingredient: 

    Benzalkonium Chloride 0.01%

  • PURPOSE

  • Direction for use

    For external use only. Open the flip top & peel back the front label slowly. Pull one wipe at a time. Gently cleanse your baby's skin using one or more wipes. Reseal pouch by firmly running thumb over label and close the flip top to prevent moisture loss.

  • Precautions:

    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 REACH OF CHILDREN

  • Other information

    Store below 25°C 

  • Ingredients

    Aqua, Pyrus Malus (apple) fruit extract, Benzalkonium Chloride.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    ZIVA WATER WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81450-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.01 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    APPLE FRUIT OIL (UNII: 9NT987I3A8)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81450-006-01100 in 1 PACKAGE12/24/2021
    16.12 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/24/2021
    Labeler - Ziva Wetwipes FZCo (559186188)
    Registrant - Dirra USA (117678868)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ziva Wetwipes FZCO559186188manufacture(81450-006)
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