Label: ETHYL RUBBING ALCOHOL- ethyl alcohol liquid

  • NDC Code(s): 70000-0020-1
  • Packager: Cardinal Health, 110 dba Leader
  • 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 July 6, 2023

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  • Active ingredient

    Ethyl alcohol 70%

  • Purpose

    First aid antiseptic

  • Uses

    first aid to help prevent the risk of infection in:

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only. If taken internally serious gastric disturbances will result.

    Flammable - keep away from fire or flame, heat spark, electrical

  • Ask a doctor before use

    for deep or puncture wounds, animal bites or serious burns

  • When using this product

    • do not get into eyes
    • do not inhale
    • do not apply over large areas of the body
    • do not use longer than 1 week
  • Stop use and ask a doctor if

    condition persists or gets worse

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Caution

    Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

  • Directions

    • clean the affected area
    • apply a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Inactive ingredients

    acetone, denatonium benzoate, methyl isobutyl ketone, water

  • Quesstions or comments?

    1-888-593-0593

  • Adverse event

    DSP-TN-21091 DSP-MO-20087

    DIST. BY CAH DUBLIN, OH 43017

    www.myleader.com      

    1-800-200-6313

    © 2023 Cardinal Health.

    CIN 5516059   REV. 5/23

  • Principal Panel Display

    LEADER

    NDC 70000-0020-1

    Ethyl

    Rubbing Alcohol

    70% by Volume

    Fisrt Aid Antiseptic

    For Rubbing and Massaging

    100% Money Back Guarantee

    16 FL OZ (1 PT) 473 mL

    WARNING FLAMMABLE - Keep away from heat, spark, electrical, fire or flame

    USE ONLY IN A WELL-VENTILATED AREA; FUMES CAN BE HARMFUL.

    CAUTION: DO NOT POINT AT SELF OR OTHERS; PRODUCT WILL SQUIRT WHEN SQUEEZED.

    image description

  • INGREDIENTS AND APPEARANCE
    ETHYL RUBBING ALCOHOL 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0020
    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
    ACETONE (UNII: 1364PS73AF)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    METHYL ISOBUTYL KETONE (UNII: U5T7B88CNP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0020-1473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/18/2019
    Labeler - Cardinal Health, 110 dba Leader (063997360)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(70000-0020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(70000-0020)
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