Label: BIOPURE 50CT ANTI BACTERIAL HAND WIPES- benzalkonium chloride cloth

  • NDC Code(s): 83535-001-01
  • Packager: QUANZHOU YUELIANGYUAN BIOTECHNOLOGY CO.,LTD
  • 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 June 18, 2023

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  • 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 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

  • Inactive ingredients

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

  • Question?

    Call 718-975-2586

  • Package label

    BP2672-DT

  • INGREDIENTS AND APPEARANCE
    BIOPURE 50CT ANTI BACTERIAL HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83535-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83535-001-0112 in 1 BOX06/18/2023
    150 in 1 CANISTER
    13.1 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/18/2023
    Labeler - QUANZHOU YUELIANGYUAN BIOTECHNOLOGY CO.,LTD (844148328)
    Establishment
    NameAddressID/FEIBusiness Operations
    QUANZHOU YUELIANGYUAN BIOTECHNOLOGY CO.,LTD844148328manufacture(83535-001)
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