Label: HY5 ALCOHOL FREE FRAGRANCE FREE FOAMING HAND 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 August 26, 2011

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  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses

    For hand sanitizing to reduce bacteria on the skin

  • WARNINGS

    Warnings

    For external use only

    When using this product avoid contact with eyes.  In case of eye contact, flush with water.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Apply one shot to dry hands, rub into skin

    No rinsing required

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Propylene Glycol, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Lauramine Oxide, Tetrasodium EDTA, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone

  • PRINCIPAL DISPLAY PANEL

    Hy5 Alcohol Free Hand Sanitizer

    Alcohol Free Fragrance Free Foaming Hand Sanitizer

    55833

    Manufactured for

    DermaCare, Inc.

    P.O. Box 25263, Sarasota, FL  34277

    Ph:  1-877-hy5-5678

    www.hy5sanitizer.com

    1200 mL 40.6 Fluid Ounces

    Rev. 08-11

    container label

  • INGREDIENTS AND APPEARANCE
    HY5 ALCOHOL FREE FRAGRANCE FREE FOAMING HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-138
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-138-121200 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/15/2011
    Labeler - Deb USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deb USA, Inc.607378015manufacture
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