Label: BIOPURE 40CT ANTI BACTERIAL HAND WIPES(FRESH SCENT)- benzalkonium chloride cloth

  • NDC Code(s): 83535-002-01, 83535-002-02
  • Packager: QUANZHOU YUELIANGYUAN BIOTECHNOLOGY CO.,LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 3, 2024

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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

  • 83535-002-01

    40

  • 83535-002-02

    83535-002-02

  • INGREDIENTS AND APPEARANCE
    BIOPURE 40CT ANTI BACTERIAL HAND WIPES(FRESH SCENT) 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83535-002
    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:83535-002-0124 in 1 BOX06/30/2023
    140 in 1 CANISTER
    13.9 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:83535-002-0236 in 1 BOX04/01/2024
    240 in 1 CANISTER
    23.9 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00306/30/2023
    Labeler - QUANZHOU YUELIANGYUAN BIOTECHNOLOGY CO.,LTD (844148328)
    Establishment
    NameAddressID/FEIBusiness Operations
    QUANZHOU YUELIANGYUAN BIOTECHNOLOGY CO.,LTD844148328manufacture(83535-002)
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