Label: BIOPURE 1400CT ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth

  • NDC Code(s): 83535-008-01
  • Packager: QUANZHOU YUELIANGYUAN BIOTECHNOLOGY CO.,LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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  • 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.

    ●Avoid freezing and excessive heat

  • Inactive ingredients

    Glycerin, Phenoxyethanol, Propylene Glycol, Water

  • Question?

    Call 718-975-2586

  • Package label

    1440art

  • INGREDIENTS AND APPEARANCE
    BIOPURE 1400CT ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83535-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83535-008-014 in 1 CARTON12/07/2023
    11400 in 1 POUCH
    11.8 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00312/07/2023
    Labeler - QUANZHOU YUELIANGYUAN BIOTECHNOLOGY CO.,LTD (844148328)
    Establishment
    NameAddressID/FEIBusiness Operations
    QUANZHOU YUELIANGYUAN BIOTECHNOLOGY CO.,LTD844148328manufacture(83535-008)
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