Label: EVAXO ADVANCED HAND SANITIZER- ethyl alcohol gel

  • 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

    Ethyl alcohol 70% v/v

  • Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Use Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    For external use only.

    Flammable, Keep away from fire or flame.

    When using this product do not use in or near the eyes. in case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

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

  • Directions

    *Put enough product in your palm to cover hands and rub hands together briskly until dry.

    *Children under 6 years of age should be supervised when using EVAXO ADVANCED HAND SANITIZER.

  • Other information

    *Store below 110° (43°C).

    *May discolor certain fabrics or surfaces.

  • INACTIVE INGREDIENT

    Inactive ingredient Water (Aqua), Isopropyl Alcohol, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum).

  • SPL UNCLASSIFIED SECTION

    ALOE

    REFRESHING GEL

    Kills More Than 99.99% of Germs

    Leaves Hands Feeling Soft & Refreshed

    Formulated For Healthcare**

    Gentle Enough For Everyday Use

    VITAMIN E

    MOISTURIZERS

    * 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
    EVAXO ADVANCED HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78376-236
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78376-236-331000 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(78376-236)
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