Label: BIOPURE ANTIBACTERIAL HAND WIPE- benzalkonium chloride cloth

  • NDC Code(s): 78691-004-00, 78691-004-01, 78691-004-02, 78691-004-03
  • Packager: QUEST USA CORP.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 12, 2024

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.12%

    Purpose

    Antimicrobial

  • Uses

    • Hand sanitizer to help reduce bacteria.
    • For use when soap and water are not available.
  • Warnings

    For external use only.

    Do not use

    • in children less than 2 months old.
    • on open skin wounds.

    When using this product 

    do not get in eyes. If contact is made rinse thoroughly with water.

    Stop use and ask a doctor 

    if irritation or rash appears and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply to hands, allow to air dry without wiping.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store in a cool, dry place.
    • Avoid freezing and excessive heat.
  • Inactive ingredients

    Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water

  • Question?

    call 718-975-2586

  • Package Labeling:1600ct

    Label

  • Package Labeling:800ct

    Bottle2

  • Package Labeling:50ct

    Bottle3

  • Package Labeling:100ct

    Bottle4

  • INGREDIENTS AND APPEARANCE
    BIOPURE ANTIBACTERIAL HAND WIPE 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78691-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78691-004-001600 in 1 BAG09/15/2020
    13.44 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:78691-004-01800 in 1 BAG09/15/202010/09/2022
    23.25 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:78691-004-0250 in 1 POUCH09/15/202009/14/2022
    35.7 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    4NDC:78691-004-03100 in 1 CANISTER09/15/202009/22/2022
    45.37 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)09/15/2020
    Labeler - QUEST USA CORP. (079869689)
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