Label: BIOPURE ANTIBACTERIAL HAND WIPES CITRUS SCENTED- benzalkonium chloride cloth

  • NDC Code(s): 74934-074-20
  • Packager: Zhejiang iColor Biotech Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 24, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

  • 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 of age.
    • 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 Contol 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°C (59°F-86°F).
    • Avoid freezing and excessive heat above 40°C (104°F).
  • Inactive ingredients

    Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Polyaminopropyl Biguanide, Propylene Glycol, Purified Water

  • Questions?

    call 718-975-2586

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    BIOPURE ANTIBACTERIAL HAND WIPES CITRUS SCENTED 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74934-074
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74934-074-2020 in 1 CANISTER12/13/202001/31/2026
    13.5 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/13/202001/31/2026
    Labeler - Zhejiang iColor Biotech Co., Ltd (554528308)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang iColor Biotech Co., Ltd554528308manufacture(74934-074)