Label: BIOPURE ANTIBACTERIAL HAND WIPES UNSCENTED- benzalkonium chloride cloth

  • 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 August 31, 2020

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

  • Drug Facts

  • 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, Methylchloroisothiazolinone, Phenoxyethanol, Propylene Glycol, Purified Water

  • Question?

    call 718-975-2586

  • Package Labeling:

    Box

  • INGREDIENTS AND APPEARANCE
    BIOPURE ANTIBACTERIAL HAND WIPES UNSCENTED 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78691-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78691-008-001400 in 1 BAG09/20/2020
    12.29 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/20/2020
    Labeler - QUEST USA CORP. (079869689)