Label: HAND SANITIZER 8OZ WITH VITAMIN E- ethyl alcohol 70%v/v liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 25, 2024

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  • Active ingredient

    Ethyl Alcohol 70%V/V

  • Purpose

    Antimicrobial

  • Uses

    For hand washing to decrease bacteria on the skin

    Recommended for repeated use

  • Warnings

    For external use only

    Flammable, keep away from heat and flame.

    Do not use

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

    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

    Briskly rub hands together until dry

    Supervise children under 6 years in the use of this product

  • Other information

    Store at room temperature

    May discolor certain fabrics

  • Inactive ingredients

    water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate

  • label

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 8OZ WITH VITAMIN E 
    ethyl alcohol 70%v/v liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-116
    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
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-116-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product01/25/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/25/2024
    Labeler - Midwood Brands, LLC (024472631)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Guoyao Jingyue Aerosol Co., Ltd.554529812manufacture(55319-116)
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