80% HAND SANITIZER- ethyl alcohol gel

80% Hand Sanitizer by

Drug Labeling and Warnings

80% Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by FAB DISTRO UNLIMITED, LLC., FAB DISTRO UNLIMITED, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Alcohol 80%

Purpose

Antiseptic

Uses

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

Warnings

For external use only. Highly flammable liquid and vapor. Causes serious eye irritation. Keep away from heat or flame.

Do Not Use

• If you are allergic to any of the ingredients
• In children less than 2 months of age
• On open skin wounds

When using this product

When using this product avoid contact with eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

Stop use or ask a doctor if

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 (1-800-222-1222) right away.

PRECAUTIONS

• Keep away from heat/sparks/open flame/hot surfaces.
• No Smoke. Keep container tightly closed.
• Avoid breathing vapors/mist/spray.
• Contaminated work clothing should not be allowed out of the workplace.
• Wear protective eye protection/face protection.
• Store in a well-ventilated place. Keep cool.
• Dispose of contents/container to a licensed treatment, storage or disposal facility (TSRF)
• If in eyes rinse continuously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.
• In case of fire use CO2, Halon (if permitted), dry chemical, or foam for extinction.

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.

Other Information

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

Inactive ingredients

Glycerin, hydrogen peroxide, purified water USP

80% Hand Sanitizer

INGREDIENTS AND APPEARANCE

80% HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78339-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78339-100-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/25/2020

Labeler - FAB DISTRO UNLIMITED, LLC. (081156943)

Establishment
Name	Address	ID/FEI	Business Operations
FAB DISTRO UNLIMITED, LLC		081156943	manufacture(78339-100)