AMERICAN HAND SANITIZER- alcohol gel

American Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 80% v/v

Purpose

Antiseptic

Use

For hand sanitizer to decrease bacteria and viruses on the skin.

Recommended for repeated use.

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

When using this product avoid contact with eyes. In case of contact with flush eyes with water.

STOP USE

Stop use and ask a doctor if irritation or redness develops or if condition persists for more than 72 hours.

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.

Directions

• Read the entire label before using this product.
• Pump a small amout of liquid into palm of hand.
• Rub thoroughly over all surfaces on both hands for 15 seconds

Other information

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

Inactive ingredients

glycerin, hydrogen peroxide, water

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

AMERICAN HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79421-004
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
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79421-004-01	150 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
2	NDC: 79421-004-02	3785 mL in 1 JUG; Type 0: Not a Combination Product	03/30/2020
3	NDC: 79421-004-03	59 mL in 1 BOTTLE; 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 - American Hand Sanitizer LLC (117295138)

Establishment
Name	Address	ID/FEI	Business Operations
American Hand Sanitizer LLC		117295138	manufacture(79421-004)