Label: HAND SANITIZER 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 28, 2021

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  • Active ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Use

    ■For handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only: hands
    Flammable, keep away from fire or flame

  • When using this product

    ■keep out of eyes.In case of contact with eyes flush thoroughly with water.
    ■avoid contact with broken skin
    ■do not inhale or ingest

  • Stop use and ask a doctor if

    ■irritation and redness develop
    ■condition persists for more than 72 hours

  • 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.

  • Directions

    ■wet hands thoroughly with product and allow to dry without wiping
    ■for children under 6, use only under adult supervision
    ■not recommended for infants

  • Other information

    ■do not store above 105°F
    ■may discolor some fabrics
    ■harmful to wood finishes and plastics

  • Inactive ingredients

    Water(Aqua), PEG-40 Hydrogenated Castor Oil, Fragrance(Parfum) , Acrylates/ C10-30Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Aloe Barbadensis Extract, Butylene Glycol, 1,2-Hexanediol, Caprylhydroxamic Acid, Citric Acid, Disodium EDTA, Tocopheryl Acetate, Red 33, Yellow 5

  • Package Label

    73549-016-01 30ml 73549-016-01 30ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73549-016
    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
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73549-016-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/30/2020
    Labeler - Fortress Expert Co., Ltd (543358697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fortress Expert Co., Ltd543358697manufacture(73549-016)
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