Label: BAROLON HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 30, 2020

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  • Drug Facts

  • Active Ingredients

    Ethyl Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Use:

    Hand sanitizer to help reduce bacteria on skin.

  • Warnings:

    Flammable. Keep away from fire or flame.
    For external use only.
    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash appears and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions:

    Put enough product in your palm to cover hands and rub hands together briskly until dry.
    Children under 6 years of age should be supervised when using.

  • Other information:

    Store below 110°F (43°C)

  • Inactive ingredients:

    Water (Aqua), Aloe Barbadensis Leaf Juice, Isopropyl Alcohol, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Tocopherol Acetate.

  • SPL UNCLASSIFIED SECTION

    MADE WITH PLANT EXTRACTS AND SKIN CONDITIONERS

    HIGH POTENCY 70% ALCOHOL FORMULA

    Dist By: BAROLON INC. SOUTH HOLLAND, IL 60473

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    BAROLON HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76723-100
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76723-100-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
    2NDC:76723-100-283785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/23/2020
    Labeler - Barolon Labs (099833566)
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