Label: ANTIBACTERIAL WIPES UNSCENTED- benzethonium chloride solution

  • 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 March 17, 2021

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.28%

  • Purpose

    Effective Against：
    *Staphylococcus aureus *Pseudomonas aeruginosa *E.coil
    *Salmi nella choleraesuis *Proteus vulgaris

  • Use

    Avoid contamination of food.Avoid direct contact with eyes as may cause eye irritation, In case of direct eye contact, immediately flush eyes with plenty of water for atleast 15 minutes.If irritation persists seek medical attention.

  • Warnings

    1.Unscrew lid from dispenser and remove foil seal from top.
    2.Take first towelette from centre of roll and place through the dispensing eye on lid.
    3.Replace lid back and open dispensing cap.
    4.Pull towelettes out through the dispensing eye for disinfecting use.
    5.Close dispensing cap after each use to avoid evaporation of product liquid.
    6.Do not mix with other detergents or disinfectant solutions.

  • Do not use

    Do not mix with other detergents or disinfectant solutions.

  • WHEN USING

    1.Unscrew lid from dispenser and remove foil seal from top.
    2.Take first towelette from centre of roll and place through the dispensing eye on lid.
    3.Replace lid back and open dispensing cap.
    4.Pull towelettes out through the dispensing eye for disinfecting use.
    5.Close dispensing cap after each use to avoid evaporation of product liquid.
    6.Do not mix with other detergents or disinfectant solutions.

  • STOP USE

    /

  • KEEP OUT OF REACH OF CHILDREN

    /

  • Directions

    Instructions for use：
    1.Unscrew lid from dispenser and remove foil seal from top.
    2.Take first towelette from centre of roll and place through the dispensing eye on lid.
    3.Replace lid back and open dispensing cap.
    4.Pull towelettes out through the dispensing eye for disinfecting use.
    5.Close dispensing cap after each use to avoid evaporation of product liquid.
    6.Do not mix with other detergents or disinfectant solutions.

  • Other information

    /

  • Inactive ingredients

    Isopropyl Alcohol 18%
    Phenoxyethanol 0.3%
    Propylene glycol 0.3%
    Pure Water

  • Package Label - Principal Display Panel

    80593-008-01 180 solution in 1 Bag

    80593-008-01 180 solution in 1 Bag

    80593-008-02 220 solution in 1 Bag

    80593-008-02 220 solution in 1 Bag

    80593-008-03 80 solution in 1 canister

    80593-008-03 80 solution in 1 canister

    80593-008-04 100 solution in 1 canister

    80593-008-04 100 solution in 1 canister

    80593-008-05 160 solution in 1 canister

    80593-008-05 160 solution in 1 canister

    80593-008-06 180 solution in 1 canister

    80593-008-06 180 solution in 1 canister

    80593-008-07 220 solution in 1 canister

    80593-008-07 220 solution in 1 canister

    80593-008-08 300 solution in 1 canister

    80593-008-08 300 solution in 1 canister

    80593-008-09 500 solution in 1 canister

    80593-008-10 800 solution in 1 canister

    80593-008-10 800 solution in 1 canister

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WIPES UNSCENTED 
    benzethonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80593-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.28 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80593-008-01180 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    2NDC:80593-008-0380 in 1 CANISTER; Type 0: Not a Combination Product03/30/2020
    3NDC:80593-008-09500 in 1 CANISTER; Type 0: Not a Combination Product03/30/2020
    4NDC:80593-008-04100 in 1 CANISTER; Type 0: Not a Combination Product03/30/2020
    5NDC:80593-008-02220 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    6NDC:80593-008-05160 in 1 CANISTER; Type 0: Not a Combination Product03/30/2020
    7NDC:80593-008-06180 in 1 CANISTER; Type 0: Not a Combination Product03/30/2020
    8NDC:80593-008-07220 in 1 CANISTER; Type 0: Not a Combination Product03/30/2020
    9NDC:80593-008-10800 in 1 CANISTER; Type 0: Not a Combination Product03/30/2020
    10NDC:80593-008-08300 in 1 CANISTER; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - ZHANGZHOU WANSIKE ELECTRONICS CO., LTD (560452758)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHANGZHOU WANSIKE ELECTRONICS CO., LTD560452758manufacture(80593-008)
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