Label: HAND SANITIZER- alcohol liquid

  • NDC Code(s): 75214-502-12, 75214-502-50
  • Packager: HANUL CO.,LTD
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 9, 2024

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  • Active Ingredient(s)

    Alcohol 80% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    to decrease bacteria on the skin that can cause disease.

  • Warnings

    For external use only: hands. Flammable. Keep away from fire or flame

  • WHEN USING

    When using the 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

    Stop use and ask a doctor if irritation or redness develops condition persists for more than 72 hours

  • 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.

  • Directions

    Place enough product to hands to cover all surface

    Rub hands together until dry

    Not recommended for infants

  • Other information

    do not store above105°F/40°C

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • Inactive ingredients

    Water. Glycerin, Hydrogen peroxide, Carbomer, Aminomethyl Propanol, Fragrance

  • Package Label - Principal Display Panel

    500 mL NDC: 75214-502-50

    120mL NDC: 75214-502-12

    120ml

    hand sanitizer

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75214-502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.12 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 17.68 mL  in 100 mL
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.3 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75214-502-50500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
    2NDC:75214-502-12120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01603/30/2020
    Labeler - HANUL CO.,LTD (557814370)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANUL CO.,LTD557814370manufacture(75214-502)
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