Label: 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 3, 2020

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  • ACTIVE INGREDIENT

    Ethanol alcohol 80% v/v ……………………………………..………………………………………………………………………...Antiseptic

  • PURPOSE

    Hand sanitizer to help reduce bacteria that potentially can cause disease.

  • INACTIVE INGREDIENT

    glycerin, hydrogen peroxide, carbomer 940, triethanolamine, purified water USP

  • DOSAGE & ADMINISTRATION

    Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL

  • WHEN USING

    For external use only. Flammable. Keep away from heat or flame

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • DO NOT USE

    In children less than 2 months of age

    On open skin wounds

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INSTRUCTIONS FOR USE

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

    Supervise children under 6 years of age when using this product to avoid swallowing.

  • OTHER SAFETY INFORMATION

    Other Information

    Store between 15-30C (59-86F)

    Avoid freezing and excessive heat above 40C (104F)

  • DOSAGE FORMS & STRENGTHS

    Gel form

  • WARNINGS

    Warnings for external use only-hands

  • INDICATIONS & USAGE

    To help reduce bacteria on the hands that can potentially cause disease.

  • PRINCIPAL DISPLAY PANEL

    ME Bio Ethyl Alcohol

  • INGREDIENTS AND APPEARANCE
    ETHYL ALCOHOL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73764-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73764-002-01500 mL in 1 BOTTLE, PUMP; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)03/23/2020
    2NDC:73764-002-02236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/23/2020
    3NDC:73764-002-03177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/23/2020
    4NDC:73764-002-04473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/23/2020
    5NDC:73764-002-05250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/23/2020
    Labeler - Marine Essence Biosciences Corporation of USA (116587566)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marine Essence Biosciences Corporation of USA116587566manufacture(73764-002) , pack(73764-002) , label(73764-002)
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