Label: ALCOHOL FREE EVAXO 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 June 2, 2020

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Use To decrease bacterial on the skin that could cause disease. Recommended for repeated use.

  • Warnings

    For external use only.

    Avoid contact with eyes. In case of contact with eyes, flush thoroughly with water.

    Stop use and ask a doctor if skin irritation develops.

    Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.

  • Directions

    For adults and children 2 yrs. and older. Apply a thumbnail size amount on palms and rub hands thoroughly until dry.

  • Other information

    Do not freeze

  • INACTIVE INGREDIENT

    Inactive ingredient Water, Cocamidopropyl Betaine, Propylene Glycol, Glycerine, Citric Acid, Cocamidopropylamine Oxide, Triethanolamine (TEA)

  • SPL UNCLASSIFIED SECTION

    Safe for Kids

    Non-dry to hands

    Non flammable

    Hypoallergenic

    Fragrance Free

    Kills 99.99% of Germs Instantly!

    * Kills More Than 99.99% of Most Common Germs that may make you sick.

    * Ounce for ounce outperforms EVAXO ADVANCED HAND SANITIZER original formulations when used on hands as directed

    THE GREEN SOURCES

    DISTRIBUTED BY: EVAXO INTERNATIONAL INC.

    Tampa, FI 33619

    All rights reserved. Made in U.S.A

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE EVAXO HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78376-239
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78376-239-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - Evaxo International Inc (003464270)
    Establishment
    NameAddressID/FEIBusiness Operations
    Evaxo International Inc003464270manufacture(78376-239)
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