Label: BIOPURE 1600CT ANTIBACTERIAL HAND WIPES- benzalkonium chloride patch

  • NDC Code(s): 79794-112-01
  • 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 August 30, 2023

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  • Active ingredient

    0.12% Benzalkonium Chloride

  • 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

    do not get in eyes. If contact is made rinse thoroughly with water.

  • Stop use and ask a doctor if

    irritation or rash appears and lasts.

  • 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, Phenoxyethanol, Propylene Glycol, Water

  • Question?

    Call 718-975-2586

  • Package label

    CT 1600

  • INGREDIENTS AND APPEARANCE
    BIOPURE 1600CT ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79794-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79794-112-014 in 1 CARTON08/30/2023
    11600 in 1 POUCH
    10.77 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 finalpart333E08/30/2023
    Labeler - Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. (723796509)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.723796509manufacture(79794-112)
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