Label: HACCP QE2- benzalkonium chloride liquid

  • NDC Code(s): 59900-718-01, 59900-718-02, 59900-718-03
  • Packager: Best Sanitizers, Inc
  • 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 2, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.12% w/w

  • PURPOSE

    Purpose

    Antiseptic Hand Cleanser

  • INDICATIONS & USAGE

    Uses

    • handwash to help reduce bacteria that potentially can cause disease
    • helps to prevent cross-contamination by hand contact
    • helps to prevent drying of the skin
    • recommended for repeated use
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product do not use in or near eyes.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develop.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • wet hands and wrists with clean, running water
    • apply appropriate amount of product
    • lather and scrub hands, fingers, fingernails, cuticles and wrists for at least 20 seconds
    • rinse thoroughly with running water
    • dry hands completely (incomplete drying may result in chapped skin)
  • STORAGE AND HANDLING

    Other information

    store in a cool dry place below 104° F (40° C)

  • INACTIVE INGREDIENT

    Inactive ingredients Water, cocamidopropyl betaine, C12-14 amine oxides, 1,2-propanediol, glycerol, guar gum, xanthan gum, benzyl alcohol, dehydroacetic acid, tetra-sodium EDTA

  • QUESTIONS

    Questions?

    Contact Best Sanitizers at 888-225-3267 Mon-Fri 9am - 4pm PST

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    BEST SANITIZERS INC.

    P.O. Box 1360

    Penn Valley, CA 95946

    www.bestsanitizers.com

  • PRINCIPAL DISPLAY PANEL

    BEST SANITIZERS INC.

    HACCP QE2

    Sanitizing Liquid Soap

    NSF [Nonfood Compounds Program Listed (E2) Registration #149724]

    0.12% Benzalkonium Chloride (BAC) formula

    Rich, thick lather

    FOR FOOD INDUSTRY PROFESSIONALS

    Net Contents: 1 U.S. Gallon (3.78 liters)

    59900-718 new

  • INGREDIENTS AND APPEARANCE
    HACCP QE2 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59900-718
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1200 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GUAR GUM (UNII: E89I1637KE)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59900-718-011200 mL in 1 BOTTLE; Type 0: Not a Combination Product07/16/2014
    2NDC:59900-718-021000 mL in 1 BAG; Type 0: Not a Combination Product07/16/2014
    3NDC:59900-718-033785 mL in 1 JUG; Type 0: Not a Combination Product07/16/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/16/2014
    Labeler - Best Sanitizers, Inc (957473614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Best Sanitizers, Inc627278224manufacture(59900-718)
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