Label: EVAXO 70% ETHYL RUBBING ALCOHOL- ethyl alcohol 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

    Ethyl alcohol (70% by volume)

  • Purpose

    First aid antiseptic

  • INDICATIONS & USAGE

    Uses First aid to help prevent the risk of infection in minor cuts, scrapes, and burns.

  • Warnings

    For external use only.

    Flammable, Keep away from fire or flame.

    Ask a doctor before use if you have deep wounds, animal bites, or serious burns

    When using this product

    *do not get into eyes.

    *do not apply over large areas of the body.

    *do not use longer than one week.

    Stop use and ask a doctor if condition persists or gets worse.

    Keep out of reach of children. in case of ingestion, get medical help or contact a poison control center right away.

  • Directions

    *Clean affected area.

    *Apply small amount of this product on the area 1-3 times daily.

    *if bandaged, let dry first.

    *may be covered with a sterile bandage.

  • Other information

    *Store at room temperature

    *will produce serious gastric disturbances if taken internally.

  • INACTIVE INGREDIENT

    Inactive ingredient purified water, Acetone 5%, Methyl isobutyl Ketone 1% and bitrex.

  • SPL UNCLASSIFIED SECTION

    keep away from heat, spark, electrical, fire or flame.

    Use only in a well-ventilated area;

    Fumes may be harmful.

    Caution: do not point at self or others; product will squirt when squeezed.

    THE GREEN SOURCES

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    DISTRIBUTED BY: EVAXO INTERNATIONAL INC.

    Tampa, FI 33619

    All rights reserved. Made in U.S.A

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    EVAXO 70% ETHYL RUBBING ALCOHOL 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78376-235
    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)  
    ACETONE (UNII: 1364PS73AF)  
    METHYL ISOBUTYL KETONE (UNII: U5T7B88CNP)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78376-235-16473 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(78376-235)
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