Label: HYDRO KLEEN AF- 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 August 1, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Uses

    • Provide hand sanitizing when soap and water not available
    • Kills or reduces 99.9% of harmful bacteria/germs
    • Recommended for repeated use
  • Warnings

    • For external use only

    • Do not use in or near the eyes

    • In case of contact with eyes, flush thoroughly with water

    • If ingested, consult with a physician

    • Keep out of range of children 2yrs of age or younger
  • Directions

    • Apply thumbnail size amount to palm
    • Rub hands together thoroughly
    • No rinsing required
  • Other Information

    Do not freeze

  • Inactive Ingredients

    Water, Polysorbate 20, Glycerin, Citric Acid, Butylene Glycol, Cocamidopropylamine Oxide, Sodium Hydroxide, Cocamidopropyl Betaine, Cetrimonium Chloride

  • Questions?

    1-877-446-8088 • www.ProductivePractices.net

  • PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

    ALCOHOL-FREE

    HYDROKLEENAF
    HAND SANITIZER

    ANTISEPTIC
    ANTI-BACTIERIAL
    DYE FREE
    FRAGRANCE FREE

    DISTRIBUTED BY

    6.7 fl oz (200ml)

    Principal Display Panel - 200 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HYDRO KLEEN AF 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69129-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.13 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Glycerin (UNII: PDC6A3C0OX)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Cocamidopropylamine Oxide (UNII: M4SL82J7HK)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69129-010-01200 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E07/31/2014
    Labeler - Productive Practices (010122499)
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