Label: BIOPURE 1400CT ANTI BACTERIAL HAND WIPES- benzalkonium chloride cloth

  • NDC Code(s): 79794-110-01
  • Packager: Zhejiang Furuisen Spunlaced Nonwovens 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 January 12, 2023

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  • Active ingredient

    Benzalkonium Chloride 0.12% ……………………………………………...Antibacterial

  • Uses

    ●Hand sanitizer to help reduce bacteria

  • PURPOSE

    ●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

  • STORAGE AND HANDLING

    ●Store in a cool, dry place， between 15°-30°C（59°F-86°F).

    ●Avoid freezing and excessive heat above 40°C（104°F）.

  • Inactive ingredients

    Glycerin, Phenoxyethanol, Propylene Glycol, Water

  • Question?

    Call 718-975-2586

  • PRINCIPAL DISPLAY PANEL

    1400CT

  • INGREDIENTS AND APPEARANCE
    BIOPURE 1400CT ANTI BACTERIAL HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79794-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 
    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:79794-110-011 in 1 BOX01/13/2023
    14 in 1 CARTON
    11400 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/13/2023
    Labeler - Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. (723796509)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.723796509manufacture(79794-110)
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