Label: HAND SANITIZER DR. BUTLER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 January 9, 2023

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 62%

  • PURPOSE


    Antiseptic

  • INDICATIONS & USAGE

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

  • WARNINGS

    For external use only. Flammable-keep away from fire or flame. When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water, avoid contact with broken skin, and do not inhale or ingest. Stop use and ask a doctor if rash or irritation develops and lasts for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

  • INACTIVE INGREDIENT

    Water, Isopropyl Alcohol, Tocopheryl Acetate, Glycerin, Propylene Glycol, Isopropyl Myristate, Carbomer, Aminomethyl Propanol.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  DR. BUTLER
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-157
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70942-157-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/26/2020
    Labeler - Beyond Health P.A. (026781064)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(70942-157)
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