Label: ADVANCED ALCOHOL GEL SANITIZER- alcohol gel

  • NDC Code(s): 65601-801-04, 65601-801-19, 65601-801-29, 65601-801-55, view more
    65601-801-57, 65601-801-99
  • Packager: Betco Corporation, Ltd
  • 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 2, 2022

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  • Active Ingredient

    Active Ingredient

    Ethyl Alcohol 70%

  • Uses

    Uses

    • Hand sanitizer to reduce microorganisms on the skin.

    • Use this product when soap and water are not available.

  • Purpose

    Purpose

    Antiseptic

  • Warnings

    Warnings

    • For external use only.

    • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    • FLAMMABLE. This product contains ethyl alcohol. Keep away from

    sources of ignition.

    • Discontinue use if irritation or redness develops.

    • If irritation persists for more than 72 hours, consult a physician.

    • KEEP OUT OF REACH OF CHILDREN.

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

  • Directions

    Directions

    • Read the entire label before using this product.

    • Place enough product on your palm to thoroughly cover your hands.

    • Rub hands together briskly until dry.

  • Inactive Ingredients

    Inactive Ingredients

    Water, PEG/PPG-8/3 Laurate, Gycerin, Carbomer, Tetrahydroxypropylethylendiamine, Fragrance.

  • Warnings

    KEEP OUT OF REACH OF CHILDREN.

  • Principal Display Panel

    AdvancedAlcoholGelSanitizer

  • INGREDIENTS AND APPEARANCE
    ADVANCED ALCOHOL GEL SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETOL (UNII: Q4R969U9FR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65601-801-19900 mL in 1 BAG; Type 1: Convenience Kit of Co-Package08/01/2019
    2NDC:65601-801-291000 mL in 1 BAG; Type 0: Not a Combination Product08/01/2019
    3NDC:65601-801-57550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2019
    4NDC:65601-801-043780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2019
    5NDC:65601-801-55208198 mL in 1 DRUM; Type 0: Not a Combination Product08/01/2019
    6NDC:65601-801-991041000 mL in 1 CONTAINER; Type 0: Not a Combination Product07/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2019
    Labeler - Betco Corporation, Ltd (024492831)
    Registrant - Betco Corporation, Ltd (024492831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd024492831manufacture(65601-801) , label(65601-801)
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