Label: HAND SANITIZER- alcohol gel

  • NDC Code(s): 80524-000-15, 80524-000-30, 80524-000-53, 80524-000-60
  • Packager: Tempo Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 15, 2023

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 62%

    Purpose

    Antiseptic

  • Uses:

    For Hand Sanitizing

  • Warnings:

    For external use only-hands.

    Flammable. Keep away from heat and flame.

    When using this product

    • Keep out of eyes. In case of contact with eyes, flush thoroughly with water
    • Avoid contact with broken skin.
    • Do not inhale or ingest.

    Stop use and ask a doctor

    If skin irritation develops

    Keep out of reach of children

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

  • Directions:

    • Wet hands thoroughly with product and allow to dry without wiping.
    • For children under 6 age use only under adult supervision.
    • Not recommended for infants
  • Other Information:

    • Do not store above 105°F. 
    • May discolor some fabrics.
    • Harmful to wood finishes and plastics
  • Inactive Ingredients

    Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

  • Package Labeling:30ml

    30 ml30 ml

  • Package Labeling:53ml

    Bottle53ml

  • Package Labeling:60ml

    Bottle60ml

  • Package Labeling:15ml

    Bottle15mlABottle15mlB

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80524-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80524-000-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    2NDC:80524-000-5353 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    3NDC:80524-000-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    4NDC:80524-000-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)09/18/2020
    Labeler - Tempo Industries, Inc. (883232993)
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