Label: ALCOHOL- 73938-2020 liquid

  • NDC Code(s): 73938-2020-1, 73938-2020-2
  • Packager: Louisville Distilling Company, LLC
  • 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 March 25, 2020

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  • ACTIVE INGREDIENT

    Alcohol 80% v/v

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

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

  • DO NOT USE

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

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • WARNINGS

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

  • DOSAGE & ADMINISTRATION

    • 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 SAFETY INFORMATION

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

  • INACTIVE INGREDIENT

    Inactive ingredients glycerin, hydrogen peroxide, purified water USP

  • PRINCIPAL DISPLAY PANEL

    Label 2

  • INGREDIENTS AND APPEARANCE
    ALCOHOL 
    73938-2020 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73938-2020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73938-2020-156780 mL in 1 DRUM; Type 0: Not a Combination Product03/24/2020
    2NDC:73938-2020-2208190 mL in 1 DRUM; Type 0: Not a Combination Product03/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/24/2020
    Labeler - Louisville Distilling Company, LLC (939097189)
    Registrant - Louisville Distilling Company LLC, (939097189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Louisville Distilling Company, LLC939097189manufacture(73938-2020)
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