Label: CLEARED FOR TAKE OFF HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% v/v

    Purpose

    Antiseptic

  • Use(s)

    To kill bacteria on the skin that could cause disease. Recommended for repeated use.

  • Warnings

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

    Do not us

    on open skin wounds or children less than 2 months of age 

    When using this product

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

    Stop us and ask a doctor 

    if irritation or rash occurs or condition persists for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

  • Directions

    Dispense a dime-sized amount onto your hands or sufficient amount to cover area, and massage thoroughly until the product is absorbed. Supervise children under 6 years of age when using this product. Not recommended for infants.

  • Inactive Ingredients

    Water (Aqua), Glycerin, Isopropyl Alcohol, Butylene Glycol, Lavandula Angustifolia (Lavender) Oil, Carbomer, Aminomethyl Propanol, Isopropyl Myristate, Linalool, Tocopheryl Acetate, Shea Butter Ethyl Esters, Sodium Ascorbyl Phosphate, Rosa Damascena Flower Extract, Geraniol, Limonene

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CLEARED FOR TAKE OFF HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83617-001
    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)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    ROSA X DAMASCENA FLOWER (UNII: JWB78P295A)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83617-001-0030 mL in 1 BOTTLE; Type 0: Not a Combination Product11/11/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)11/11/2022
    Labeler - Careeon LLC (119058531)
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