ONE EIGHT DISTILLING HAND SANITIZER liquid

One Eight Distilling Hand Sanitizer by

Drug Labeling and Warnings

One Eight Distilling Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by One-Eight Distilling, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient(s)

Alcohol 80% v/v ... Antiseptic

PURPOSE

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when water and soap are not available

DO NOT USE

Do not use

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and aska doctor if irritation or tash occurs. These may be signs of a serious condition.

WHEN USING

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

OTHER SAFETY INFORMATION

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

WARNINGS AND PRECAUTIONS

Warnings

For external use only. Flammable. Keep away from heat or flame.

INSTRUCTIONS FOR USE

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.

INACTIVE INGREDIENT

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

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.

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 right away.

INDICATIONS & USAGE

Use[s]

Hand Sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.

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.

PRINCIPAL DISPLAY PANEL

[DISTRICT MADE logo]

[WE ARE WASHINGTON DC logo]

[ONE EIGHT DISTILLING logo]

ONE EIGHT DISTILLING, LLC

BATCH ______ DATE: _______

ALCOHOL ANTISPECTIC 80%

TOPICAL SOLUTION

HAND SANITIZER

NON-STERILE SOLUTION

INGREDIENTS AND APPEARANCE

ONE EIGHT DISTILLING HAND SANITIZER 
one eight distilling hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74211-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	141.6 mL  in 177 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	32.6 mL  in 177 mL
GLYCEROL FORMAL (UNII: 3L7GR2604E)	2.57 mL  in 177 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.23 mL  in 177 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74211-0001-1	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
2	NDC: 74211-0001-2	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
3	NDC: 74211-0001-3	414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - One-Eight Distilling, LLC (061879997)

Establishment
Name	Address	ID/FEI	Business Operations
One-Eight Distilling, LLC		061879997	manufacture(74211-0001)