Label: HAND SANITIZER- 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 February 19, 2021

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 68%

  • Purpose

     Antiseptic

  • Use

    Hand sanitizer to reduce bacteria on skin

  • Warnings

    Flammable, keep away from fire and flame.

    For external use only

    When using this product

    do not use in or near eyes, in case of contact, rinse eyes thoroughly with water.

    Keep out of reach of children.

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

  • Directions

    Place product on hands, rub until dry.

  • Inactive ingredients

    Glycerin, Propylene Glycol, Triethanolamine, Carbomer, Fragrance, Disodium EDTA, Tocopheryl acetate, Deionized Water

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75613-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75613-018-0120 mL in 1 BOTTLE; Type 0: Not a Combination Product02/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/19/2021
    Labeler - Ningbo Lanzi Cosmetic Technology Co., Ltd (554530929)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Lanzi Cosmetic Technology Co., Ltd554530929manufacture(75613-018)
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