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

Drug Label Information

Updated November 18, 2024

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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
    HEXYL SALICYLATE (UNII: 8F78EY72YL)  
    OCTOXYNOL-13 (UNII: 480KVF3EBY)  
    PROPYLENE OXIDE (UNII: Y4Y7NYD4BK)  
    NEROL (UNII: 38G5P53250)  
    CITRONELLOL (UNII: P01OUT964K)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    .ALPHA.-PINENE (UNII: JPF3YI7O34)  
    LINALOOL (UNII: D81QY6I88E)  
    ALLYL CYCLOHEXANEPROPIONATE (UNII: H4W9H3L241)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    GERANIOL (UNII: L837108USY)  
    CYCLOHEXANE (UNII: 48K5MKG32S)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETOL (UNII: Q4R969U9FR)  
    .GAMMA.-TERPINENE (UNII: 4YGF4PQP49)  
    ALOE BARBADENSIS LEAF EXTRACT (UNII: ZY81Z83H0X)  
    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 Drug505G(a)(3)08/01/2019
    Labeler - Betco Corporation, Ltd (005050158)
    Registrant - Betco Corporation, Ltd (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd005050158manufacture(65601-801) , label(65601-801)
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