Hand Sanitizer by AustarPharma, LLC HAND SANITIZER gel

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Alcohol 75%

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to remove dirt and germs from hands at any time; Prevent indirect transmission of germs and provide skin with better protection.

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 wound

WHEN USING

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

STOP USE

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

• side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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

• put enough product on hands to cover all surfaces and rub hands together until dry.
• supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Inactive ingredients

water, ethanol, glycerin, carbomer, aminomethyl propanol

Package Label - Principal Display Panel

2oz NDC: 35561-354-20

Package Label - Principal Display Panel

4oz NDC: 35561-354-21

Package Label - Principal Display Panel

8oz NDC: 35561-354-22

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35561-354
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35561-354-20	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
2	NDC: 35561-354-21	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020
3	NDC: 35561-354-22	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/27/2020

Labeler - AustarPharma, LLC (362785011)