Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID aebf09e4-5a7f-c968-e053-2a95a90ab18b
Route
TOPICAL
Published
Effective Date 2020-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Rapidgel Ez1 Hydrogen Peroxide Glycerin Water Maltodextrin Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-07

Description

Ethyl Alcohol 70%

Purpose

Hand and Skin Antiseptic


Medication Information

Purpose

Hand and Skin Antiseptic

Description

Ethyl Alcohol 70%

Uses

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

Warning

For extgernal use only

Flammable

Keep away from heat or flame

Directions

* Place enough product on hands to cover all surfaces

* Rub Hands together until dry

Do Not Use

* In Children less than 2 months of age

* On open skin wounds

Active Ingredient

Ethyl Alcohol 70%

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

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

Ask A Doctor Before Use If You Have

* Irritation or rash occurs


Structured Label Content

Uses

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

Purpose

Hand and Skin Antiseptic

Warning

For extgernal use only

Flammable

Keep away from heat or flame

Directions

* Place enough product on hands to cover all surfaces

* Rub Hands together until dry

Do Not Use (Do not use)

* In Children less than 2 months of age

* On open skin wounds

Active Ingredient (Active ingredient)

Ethyl Alcohol 70%

Inactive Ingredients (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

Stop Use and Ask Docotr If (Stop use and ask docotr if)

* redness or skin irritation develop after use.

Keep Out of Reach of Children (Keep out of reach of children)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

* Irritation or rash occurs


Advanced Ingredient Data


Raw Label Data

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