Label: OPI PERSONAL CARE SUPPLIES INSTANT FOAMING HAND SANITIZER NON ALCOHOL- husky 514 solution

  • 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 March 8, 2010

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Uses

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

    For external use only

    When using this product avoid contact with eyes. In case of eye contact, flush eyes 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 a 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, dihydroxpropyl PEG-5 linoleammonium chloride, glycereth-2 cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

  • Principal Display Panel

    OPI Personal Care Supplies

    Instant Foaming Hand Sanitizer Non Alcohol

    Ready-to-Use

    • Enhanced with Moisturizers
    • Kills disease causing germs within seconds
    • Effective against MRSA, VRE, E. coli (0157:H7) Staphylococcus, Streptococcus and other organisms
    • Assists with OSHA Bloodborne Pathogen Standard Compliance

    See Drug Facts panel for additional information.

    For Hospital and Professional Use Only

    Instant Foaming Hand Sanitizer Non Alcohol Label
  • INGREDIENTS AND APPEARANCE
    OPI PERSONAL CARE SUPPLIES INSTANT FOAMING HAND SANITIZER NON ALCOHOL 
    husky 514 solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43196-514
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    dihydroxypropyl peg-5 linoleammonium chloride (UNII: 0Y0NQR2GH1)  
    glycereth-2 cocoate (UNII: JWM00VS7HC)  
    behentrimonium chloride (UNII: X7GNG3S47T)  
    dihydroxyethyl cocamine oxide (UNII: 8AR51R3BL5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43196-514-053785 mL in 1 BOTTLE
    2NDC:43196-514-83550 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33311/16/2009
    Labeler - OPI Correctional Industries (809174501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canberra Corporation068080621MANUFACTURE
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