Label: DUROKLEEN SANITIZING WIPE- 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 January 25, 2021

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.10%

  • Purpose

    Antiseptic, Hand Sanitizer, Antibacterial

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    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.

  • STOP USE

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Rub cloth product on hands to cover and wet all surfaces. Allow to dry without wiping
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    hydrogen peroxide, Ztrex 72 MUP, purified water USP, non-woven cloth

  • Package Label - Principal Display Panel

    DuroKlean FrontDuroklean Rear100 count in one canister NDC: 77368-911-10

  • INGREDIENTS AND APPEARANCE
    DUROKLEEN SANITIZING WIPE 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77368-912
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYLTETRADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: N7BH1NTV97) 0.2 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.2 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77368-912-10100 in 1 CANISTER03/30/2020
    1245 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:77368-912-20200 in 1 CANISTER03/30/2020
    2490 mL in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:77368-912-0770 in 1 PACKAGE03/30/2020
    3172 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - NuGenTec (090331927)
    Registrant - NuGenTec (090331927)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuGenTec090331927manufacture(77368-912)
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