Label: ANTIBACTERIAL WIPES 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 4, 2020

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.2%

  • Purpose

    Antimicrobial

  • Use

    For hand sanitizing to decrease bacteria.

  • Warnings

    For external use only.

    Keep out of eyes. In case of eye contact, rinse eyes with water.

    Keep out of sunlight.

  • WHEN USING

    If eye contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if rednes or irritation develops;

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed get medical help or contact a Poison Control center right away.

  • Directions

    Peel back flap on front to pull out a towelette. Reseal the flap. No need to rinse.

  • Inactive ingredients

    Water, Glycerin, Propylene Glycol, Polyaminopropyl Biguanide, Phenoxyethanol, Iodopropynyl Butylcarbamate, Green Tea Extract.

  • Package Label - Principal Display Panel

    100 PATCH in 1 PACKET NDC: 40562-015-01 100pcs label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WIPES 
    antibacterial wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40562-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40562-015-01100 in 1 PACKET08/04/2020
    15.5 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/04/2020
    Labeler - Anhui Hanbon Daily Chemical Co., Ltd. (405624856)
    Establishment
    NameAddressID/FEIBusiness Operations
    Star Marketing Internation. Inc.026958555label(40562-015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anhui Hanbon Daily Chemical Co., Ltd.405624856manufacture(40562-015)
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