Label: HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 73326-001-01
  • Packager: Jacent Strategic Merchandising, LLC.
  • 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 August 27, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients:
    Ethanol 62%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use

    To decrease bacteria on the skin .

  • WARNINGS

    Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

    Do not use in the eyes.

  • STOP USE

    Discontinue use if irritation or redness develop. If condition persists for more that 72 hours, consult a doctor.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Rub into skin until dry.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Vitamin E, Glycerin, Propylene Glycol, Fragrance, Acrylates/C10-C30 alkyl acrylate crosspolymer, Triethanolamine.

  • OTHER SAFETY INFORMATION

    Other Information

    Store below 110F. Avoid direct sunlight, fluorescent lightning,heat and moisture.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73326-001
    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
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73326-001-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/28/2019
    Labeler - Jacent Strategic Merchandising, LLC. (081310578)
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