Label: HY5- 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 9, 2010

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Antibacterial

  • PURPOSE

    • 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
    • Keep out of reach of children 2 years of age or younger
    • Avoid contact with eyes
    • If ingested, consult with a physician
  • DOSAGE & ADMINISTRATION

    • Apply thumbnail size amount to palm
    • Rub hands together thoroughly
    • No rinsing required
  • SPL UNCLASSIFIED SECTION

    Do not freeze

  • INACTIVE INGREDIENT

    Water, Cocamidopropyl Betaine, Propylene Glycol, Glycerine, Cetrimonium Chloride, Cocamidopropylamine Oxide, Triethanolamine, Citric Acid

  • QUESTIONS

    1-877-Hy5-5678   www.Hy5sanitizer.com

  • PRINCIPAL DISPLAY PANEL

    Image of 4L Jug Label

    Image of 4L Jug Label


  • INGREDIENTS AND APPEARANCE
    HY5   ALCOHOL FREE
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50136-555
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.13 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    Cetrimonium Chloride (UNII: UC9PE95IBP)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Glycerin (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50136-555-014 L in 1 JUG
    2NDC:50136-555-020.05 L in 1 BOTTLE, DISPENSING
    3NDC:50136-555-030.22 L in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33311/30/2009
    Labeler - MGS Brands, Inc. (805890329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries255106239manufacture
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