Label: ETHYL RUBBING ALCOHOL 70 PERCENT- 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 December 22, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% by volume

  • Purpose

    First aid antiseptic

  • Use

    First aid to help prevent the risk of infection in.

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only.

    • Flammable, keep way from spark, heat and flame.
  • Ask a doctor before use for

    • deep wounds
    • animal bites
    • 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 1 week
  • Stop use and ask a doctor if

    condition persists or gets worse

  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

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

    • store at room temperature
    • will produce serious gastric disturbances if taken internally.
  • Inactive Ingredient

    Acetone 5%

    Methyl isobutyl ketone 1%

    bitrex

    purified water

  • Principal Display Panel

    NDC 46122-329-43
    RUBBING ALCOHOL
    ETHYL ALCOHOL     70%
    USP
    First Aid Antiseptic
    16 fl oz (1 pt) 473 mL

    Principal Display Panel NDC 46122-329-43 RUBBING ALCOHOL ETHYL ALCOHOL 70% USP First Aid Antiseptic 16 fl oz (1 pt) 473 mL

  • INGREDIENTS AND APPEARANCE
    ETHYL RUBBING ALCOHOL 70 PERCENT 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    METHYL ISOBUTYL KETONE (UNII: U5T7B88CNP)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-9100-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2016
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(0395-9100) , analysis(0395-9100) , pack(0395-9100) , label(0395-9100)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!