Label: HAND SANITIZER- 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 May 17, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    • for hand sanitizing to decrease bacteria on skin
    • recommended for repeated use
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product avoid contact with the eyes. In case of eye contact, flush eyes with water.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develop

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally into palm of hand
    • rub hands together until dry
    • no need to rinse
  • INACTIVE INGREDIENT

    Inactive ingredients Purified Water, Glycerin, Aloe Barbadensis Leaf Juice, Decyl Glucoside

  • SPL UNCLASSIFIED SECTION

    Manufactured for Terraboost Media, LLC, 3109 Grand Avenue #300, Miami, FL 33133

    www.tazzabrands.com

    A Product of Terraboost® • or Made in Taiwan • www.tazzabrands.com

  • PRINCIPAL DISPLAY PANEL

    Tazza Instant Hand Sanitizer Foam

    fragrance free

    alcohol-free

    Kills 99.99% of Germs

    6000 PUMPS

    81.15 Fl. OZ. (2,400mL)

    76370-0002 BZK LIQTW 11-17

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76370-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76370-0002-51000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/27/2015
    2NDC:76370-0002-62400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/27/2015
    3NDC:76370-0002-7300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2020
    4NDC:76370-0002-830 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2020
    5NDC:76370-0002-9500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/27/2015
    Labeler - Tazza Brands East Inc. (117842371)
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