Label: DUROKLEEN SANITIZER- benzalkonium chloride liquid

  • 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

    • Spray product on hands to cover and wet all surfaces. Rub thoroughly. 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

    Ztrex 72 MUP, purified water USP

  • Package Label - Principal Display Panel

    750mL is one bottle NDC: 77368-901-75 DuroKleanSpray FrontDuroKleanSpray Back

  • INGREDIENTS AND APPEARANCE
    DUROKLEEN SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77368-902
    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
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77368-902-75750 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/14/2021
    2NDC:77368-902-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/14/2021
    3NDC:77368-902-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2021
    4NDC:77368-902-0518927 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2021
    5NDC:77368-902-013786 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2021
    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(77368-902)
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