Label: BAC OFF- 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 June 2, 2010

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  • ACTIVE INGREDIENT

    Active ingredients                                                          Purpose

    Benzalkonium Chloride 0.1%..........................................Antimicrobial

  • INDICATIONS & USAGE

    Uses:

    For hand sanitizing to decrease bacteria on the skin.

    Recommended for repeated use.
  • WARNINGS

    Warnings

    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.

  • DOSAGE & ADMINISTRATION

    Directions:

    Pump a small amount of foam into palms of hand.

    Rub thoroughly over all surfaces of both hands.

    Rub hands together briskly until dry.


  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water (aqua), dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2-cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide.

  • PRINCIPAL DISPLAY PANEL

    Wayne

    Select Line

    BAC OFF

    Instant Foam Hand Sanitizer

    Manufactured by:

    Wayne Concept Manufacturing Co., Inc.

    Fort Wayne, IN 46825        260-482-8615

    Net Contents: 1 U.S. Gallon (3.785 L)

    Serving the maintenance community since 1933

    container label



  • INGREDIENTS AND APPEARANCE
    BAC OFF  
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64495-2362
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.1 mL  in 100 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:64495-2362-8532 mL in 1 BOTTLE, PUMP
    2NDC:64495-2362-13785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33303/31/2008
    Labeler - Wayne Concept Manufacturing Co Inc (198433179)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wayne Concept Manufacturing Co Inc198433179manufacture
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