Label: HAND SANITIZER- 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 March 21, 2022

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  • Active Ingredient(s)

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Use

    decreases bacteria on the skin that could cause disease
    I 1 recommended for repeated use

  • 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 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

  • Inactive ingredients

    Inactive Ingredients Water(aqua),fragrance (parfum ),
    Acrylates/C10-30 alkyl acrylate crosspolymer, Glycerin,
    Triethanolamine, Tocopheryl acetate, Aloe barbadensis leaf extract,
    Denatonium benzoate, Phenoxyethanol, Etylhexylglycerin

  • Package Label - Principal Display Panel

    1

    2

    3456

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-911
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-911-01325 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2020
    Labeler - Landy International (545291775)
    Registrant - Landy International (545291775)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(51706-911)
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