AMERICAN HAND SANITIZER- alcohol liquid
American Hand Sanitizer LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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American Hand Sanitizer Liquid 80

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

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. 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

label label label

AMERICAN HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79421-003
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79421-003-01	150 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
2	NDC:79421-003-02	3785 mL in 1 JUG; Type 0: Not a Combination Product	03/30/2020

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

Labeler - American Hand Sanitizer LLC (117295138)

Name	Address	ID/FEI	Business Operations
Establishment
American Hand Sanitizer LLC		117295138	manufacture(79421-003)