Label: HAND SANITIZER GEL- 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 April 2, 2021

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  • Active ingredient

    Ethyl alcohol 70.3% w/w

  • Purpose

    Antimicrobial

  • Use

    • Hand sanitizer to help decrease bacteria on the skin
  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts

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

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using the product
  • Other information

    • Store below 110°F (43°C)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Water, Glycerin, Carbomer, Polyacrylate Crosspolymer-6, Octyldodeceth-16, Tromethamine, Ammonium Acryloyldimethyltaurate/VP Copolymer, Butylene Glycol, t-Butyl Alcohol, 1,2-Hexanediol, Portulaca Oleracea Extract

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81601-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.703 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    OCTYLDODECETH-16 (UNII: RJV574G0DE)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PURSLANE (UNII: M6S840WXG5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81601-001-0165 mL in 1 TUBE; Type 0: Not a Combination Product04/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/02/2021
    Labeler - Cellicon Lab Inc. (689056488)
    Registrant - Cellicon Lab Inc. (689056488)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cellicon Lab Inc.695097499manufacture(81601-001)
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