28 MILE TOUGH TOWN HAND SANITIZER- ethyl alcohol gel TOUGH TOWN HAND SANITIZER- ethyl alcohol gel

28 Mile Tough Town Hand Sanitizer by

Drug Labeling and Warnings

28 Mile Tough Town Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by 28 Mile Vodka Company LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

28 MILE TOUGH TOWN HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77340-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77340-004-04	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/07/2020

28 MILE TOUGH TOWN HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77340-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77340-006-05	3785.41 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/07/2020
2	NDC: 77340-006-04	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/07/2020

TOUGH TOWN HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77340-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77340-007-04	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/07/2020
2	NDC: 77340-007-05	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/07/2020

TOUGH TOWN HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77340-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77340-008-04	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/07/2020

TOUGH TOWN HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77340-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77340-009-04	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/07/2020

28 MILE TOUGH TOWN HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77340-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77340-005-04	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/07/2020

Labeler - 28 Mile Vodka Company LLC (107153056)

Registrant - 28 Mile Vodka Company LLC (107153056)

Establishment
Name	Address	ID/FEI	Business Operations
28 Mile Vodka Company LLC		107153056	manufacture(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)