Label: 28 MILE TOUGH TOWN HAND SANITIZER- ethyl alcohol gel
TOUGH TOWN HAND SANITIZER- 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 October 30, 2020

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  • Active ingredient

    Ethyl Alcohol 70%

  • Purpose

    Hand and Skin Antiseptic

  • Uses

    Hand & Skin Antiseptic to help decrease pathogens (germs) on the skin

  • Warning

    For extgernal use only

    Flammable

    Keep away from heat or flame

    Do not use

    * In Children less than 2 months of age

    * On open skin wounds

    Ask a doctor before use if you have

    * Irritation or rash occurs

    Stop use and ask docotr if

    * redness or skin irritation develop after use.

    Keep out of reach of children

    Supervise children under 6 years of age when using this product to avoid swallowing

  • Directions

    * Place enough product on hands to cover all surfaces

    * Rub Hands together until dry

  • Inactive ingredients

    Water, Glycerine, PEG-6, Acrylates/Vinyl Cross polymer, Polyethylene Glycol, 1,2,3 - Propanetriol, 1,3-Propanediamine, Gycerol, Xanthan Gum, Maltodextrin, Fragrance

  • Principal Display Panel

    28 Mile Tough Town Hand sanitizer

    Tough Town Hand Sanitizer

    Cumuber Mint Scented

    Lavebder Rose Scented

    Unscented

    For external use only,

    Do not Drink

    28 Mile Distilling Company and Tough Town Hand Sanitizer are aptly named after Highwood, IL, the place we call home. Situated just 28 miles north of Chicago, Highwood had a reputation that once led President Theodore Roosevelt to call it "the toughest town in America". Out toughness and resiliency still holds true today as is reflected in the products we produce. Stay safe, stay clean, stay tough.

    Produce by:

    28 Mile Distilling Co.

    454 Sheridon Road, Highwood

    IL 60040

    Alcohol Antiseptic 70% Topical Solution

    Hand Sanitizer Non-sterile solution

    NDC: 77340-004-xx; 77340-005-xx; 77340-006-xx; 77340-007-xx; 77340-008-xx; 77340-009-xx

    009-04-Hand sanitizer

    008-04-Hand sanitizer

    007-05-Hand sanitizer

    007-04-Hand sanitizer

    006-05-Hand sanitizer

    006-04-Hand sanitizer

    005-04-Hand sanitizer

    004-04-Hand sanitizer

  • INGREDIENTS AND APPEARANCE
    28 MILE TOUGH TOWN HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77340-004
    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
    RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77340-004-04473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/07/2020
    28 MILE TOUGH TOWN HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77340-006
    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
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77340-006-053785.41 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/07/2020
    2NDC:77340-006-04473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/07/2020
    TOUGH TOWN HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77340-007
    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)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77340-007-04473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/07/2020
    2NDC:77340-007-053785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/07/2020
    TOUGH TOWN HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77340-008
    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
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77340-008-04473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/07/2020
    TOUGH TOWN HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77340-009
    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
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77340-009-04473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/07/2020
    28 MILE TOUGH TOWN HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77340-005
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77340-005-04473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/07/2020
    Labeler - 28 Mile Vodka Company LLC (107153056)
    Registrant - 28 Mile Vodka Company LLC (107153056)
    Establishment
    NameAddressID/FEIBusiness Operations
    28 Mile Vodka Company LLC107153056manufacture(77340-004, 77340-005, 77340-006, 77340-007, 77340-008, 77340-009) , label(77340-004, 77340-005, 77340-006, 77340-007, 77340-008, 77340-009)
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