Label: MYHEALTH ALCOHOL ANTISEPTIC HAND SANITIZER- alcohol liquid

  • NDC Code(s): 80661-001-01
  • Packager: Aeroflex Industria de Aerosol Ltda
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 10, 2024

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  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Warnings

    For external use only.Flammable.Keep away from heat or flame.

    Do not use

    • in children less than 2 months of age
    • on open skin wounds

    When using this productkeep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctorif irritation or rash occurs.These may be signs of a serious condition.

  • Keep out of reach of children.

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

  • Uses

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

  • Directions

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

    • Store between 15-30C (59-86F)
    •  Avoid freezing and excessive heat above 40C (104F)
  • Inactive Ingredients

    aqua, butane, isobutane, propane, glycerin, parfum, triclosan, denatonium benzoate,butylphenyl methylpropional, linalool.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    MYHEALTH ALCOHOL ANTISEPTIC HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80661-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTANE (UNII: 6LV4FOR43R)  
    SULFURYL FLUORIDE (UNII: 64B59K7U6Q)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPANE (UNII: T75W9911L6)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80661-001-01150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00309/26/2020
    Labeler - Aeroflex Industria de Aerosol Ltda (898397347)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aeroflex Industria de Aerosol Ltda898397347manufacture(80661-001)
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