Active Ingredient
Ethyl Alcohol 70%
28 Mile Tough Town Hand Sanitizer
FDA Label NDC 77340-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by 28 Mile Vodka Company Llc for the product 28 Mile Tough Town Hand Sanitizer (NDC 77340-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warning, do not use, ask a doctor before use if you have, stop use and ask docotr if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Please review the disclaimer below.
