Label: JOURNEYMAN DISTILLERY HAND SANITIZER- ethanol solution

  • 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 May 20, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Alcohol 80% v/v

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Use

    • hand sanitizer to help reduce bacteria that potentially can cause disease.
    • for use when soap and water are not available.
  • WARNINGS

    Warnings
    For external use only.

    Flammable. Keep away from heat or flame.

    Do not use

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

    When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • 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.
  • STORAGE AND HANDLING

    Other information

    • store between 15-30°C (59-86°F)
    • avoid freezing and excessive heat above 40“C (104°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • SPL UNCLASSIFIED SECTION

    JOURNEYMAN DISTILLERY
    THREE OAKS, MI 49128
    269-820-2050
    JOURNEYMANDISTILLERY.COM

  • PRINCIPAL DISPLAY PANEL

    JOURNEYMAN Distillery

    HAND SANITIZER

    WARNING: NOT FOR CONSUMPTION

    ALCOHOL ANTISEPTIC 80%

    NON-STERILE TOPICAL SOLUTION

    2 FL OZ / 59 ML

    Journeyman HS 2 oz_FINAL

  • INGREDIENTS AND APPEARANCE
    JOURNEYMAN DISTILLERY HAND SANITIZER 
    ethanol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77395-001
    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)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77395-001-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/20/2020
    Labeler - Journeyman Distillery, LLC (013794196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Journeyman Distillery, LLC013794196manufacture(77395-001)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!