BAC OFF (BENZALKONIUM CHLORIDE) LIQUID [WAYNE CONCEPT MANUFACTURING CO INC]

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BAC OFF (BENZALKONIUM CHLORIDE) LIQUID [WAYNE CONCEPT MANUFACTURING CO INC]
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NDC 64495-2362-1, 64495-2362-8
Set ID 5fce3a50-3195-4891-a6ac-7b5aef4e80ea
Category HUMAN OTC DRUG LABEL
Packager Wayne Concept Manufacturing Co Inc
Generic Name
Product Class
Product Number
Application Number PART333
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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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