Label: BIOPURE ANTIBACTERIAL HAND WIPE- benzalkonium chloride cloth

  • NDC Code(s): 78691-017-00, 78691-017-01
  • Packager: Quest USA Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Uses

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

    For external use only.

    Do not ues 

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

    When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or rash occurs. These may be signs of a serious condition.

    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

    Aloe Barbadensis Leaf Extract, Alpha-Tocopherol, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water

  • Questions?

    call 718-975-2586

  • 78691-017-00

    Label

  • 78691-017-01

    Label2

  • INGREDIENTS AND APPEARANCE
    BIOPURE ANTIBACTERIAL HAND WIPE 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78691-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78691-017-0050 in 1 CANISTER01/15/202312/31/2023
    12.9 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:78691-017-0150 in 1 CANISTER01/15/2023
    23.4 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)01/15/2023
    Labeler - Quest USA Corp (079869689)
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