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 25, 2021

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 75% v/v Purpose: Antiseptic

  • INDICATIONS & USAGE

    Keep out of eyes, ears, and mouth. In case of contact with the eyes, rinse eyes thoroughly with water.

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise with children under 6 years of age when using this product to avoid swallowing.
  • WARNINGS

    • on chilren less then 2 months of age
    • on open skin wounds

    if irritation or rash occurs. These may be signs of a serious condition.

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

  • DOSAGE & ADMINISTRATION

    Apply dime size amount to hands and

    Hand sanitizer to help reuce bacteria that potentially can cause disease. For use when soap and water are not available.

  • QUESTIONS

    Visit penta5usa.com or call toll free 1-800-511-5609

  • OTHER SAFETY INFORMATION

    • Store between 15-30 Degrees C (59-86 F)
    • Avoid freexing and excessive heat about 40 C (104 F)
  • INACTIVE INGREDIENT

    Water, Carbopol Aqua SF1, Hydrogen Peroxide 3%, Glycerol, Fragrance, AMP PC2000

  • PRINCIPAL DISPLAY PANEL

    236 ML Bottle- NDC 80589-001-01236 ML, NDC: 80589-001-01

  • PRINCIPAL DISPLAY PANEL

    59 mL NDC 80589-001-02

    59 mL NDC 80589-001-02

  • PRINCIPAL DISPLAY PANEL

    3785 mL, NDC 80589-001-03 3785 mL NDC 80589-001-03

  • PRINCIPAL DISPLAY PANEL

    60 mL NDC 80589-001-04

    60 ML NC 80589-001-04

  • PRINCIPAL DISPLAY PANEL

    133 mL NDC 80589-001-05 133 mL NDC 80589-001-05

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80589-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
    .ALPHA.,.BETA.-METHYLENE ADENOSINE 5'-DIPHOSPHATE (UNII: 0T2A5439OE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80589-001-01236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/29/2021
    2NDC:80589-001-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product03/29/2021
    3NDC:80589-001-033785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/29/2021
    4NDC:80589-001-0459 mL in 1 BOTTLE; Type 0: Not a Combination Product03/29/2021
    5NDC:80589-001-05133 mL in 1 POUCH; Type 0: Not a Combination Product03/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/29/2021
    Labeler - Black Irish Products, LLC. (131420039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Redi-2-PaQ Home Products, LLC.081148102manufacture(80589-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Black Irish Products131420039label(80589-001)
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