Label: BIOPURE ANTIBACTERIAL HAND WIPES BENZALKONIUM CHLORIDE 0.12% - 250 WIPES- benzalkonium chloride cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2024

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.12%

    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 use

    • 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, between 15°-30° (59°-86°F). • Avoid freezing and excessive heat above 40°C (104°F).

  • Inactive ingredients

    Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water

  • Questions?

    call 718-975-2586

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    BIOPURE ANTIBACTERIAL HAND WIPES BENZALKONIUM CHLORIDE 0.12% - 250 WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78691-009
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78691-009-00250 in 1 CONTAINER09/20/2020
    12.8 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)09/20/2020
    Labeler - QUEST USA CORP. (079869689)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.723796509manufacture(78691-009)
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