Label: EVAXO 91% ISOPROPYL ALCOHOL- isopropyl 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 4, 2020

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  • Drug Facts

  • Active ingredient (by volume)

    Isopropyl alcohol (91% conc.)

  • 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.

    *if taken internally, serious gastric disturbances will result

    Flammable, Keep away from fire or flame.

    *Use only in a well-ventilated area; fumes may be toxic.

    Ask a doctor before use if you have deep or puncture 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 unless directed by doctor.

    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

    *does not contain, nor is intended as a substitute for grain or ethyl alcohol

  • INACTIVE INGREDIENT

    Inactive ingredient purified water

  • SPL UNCLASSIFIED SECTION

    Antiseptic

    * Topical Antiseptic and Sanitizer.

    * Antibacterial Cleansing Agent for Minor Cuts and Abrasions.

    * For Preparation of Skin Prior to an Injection.

    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 91% ISOPROPYL ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78376-241
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL91 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78376-241-32946.6 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - Evaxo International Inc (003464270)
    Establishment
    NameAddressID/FEIBusiness Operations
    Evaxo International Inc003464270manufacture(78376-241)
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