Label: HILLYARD ALCOHOL FREE FOAMING INSTANT HAND SANITIZER- benzalkonium chloride liquid

  • NDC Code(s): 76402-403-02, 76402-403-03, 76402-403-06, 76402-403-82
  • Packager: Hillyard GMP
  • 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, 2015

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  • Active ingredient

    Benzalkonium Chloride 0.10%

  • Purpose

    Antimicrobial

  • Uses

    •
    For hand sanitizing to decrease bacteria on the skin
    •
    Recommended for repeated use.
  • Warnings

    •
    For External Use Only
  • When using this product

    avoid contact with eyes. In case of eye contact, flush eyes thoroughly with water.

  • Stop use and ask a doctor if

    irritation or redness develops, or if condition persists for more than 72 hours.

  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •
    Pump small amount of foam into palm of hand
    •
    Rub thoroughly over all surfaces of both hands
    •
    Rub hands together briskly until dry
  • Inactive Ingredients

    Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Phenoxyethanol and Citric Acid.

  • Package/Label Principal Display Panel

    Hillyard
    Alcohol Free Foaming
    Instant Hand Sanitizer

    HIL0040303

    affinity
    DISPENSING SYSTEM

    Place cartridge into dispenser, label facing back, and gently push pump into receiver until it clicks into place.

    To remove the cartridge and pump, rotate the green ring clockwise and pull the pump out.

    HILLYARD INDUSTRIES
    PO Box 909,
    St. Joseph, MO
    64502-0909 U.S.A.
    Telephone: 816-233-1321
    www.hillyard.com

    NET CONTENTS 1.25 L (42.3 FL. OZ.)
    PEEL HERE

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    HILLYARD ALCOHOL FREE FOAMING INSTANT HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76402-403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76402-403-063785 mL in 1 JUG; Type 0: Not a Combination Product02/29/2012
    2NDC:76402-403-031250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/02/2012
    3NDC:76402-403-021000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/04/2012
    4NDC:76402-403-82414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/29/2012
    Labeler - Hillyard GMP (969081483)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hillyard GMP969081483MANUFACTURE(76402-403)
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