Hand Sanitizer Spray 1 Gallon

Assured Bio Infection Protection Hand Sanitizer by

Drug Labeling and Warnings

Assured Bio Infection Protection Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Assured Bio Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ASSURED BIO INFECTION PROTECTION HAND SANITIZER- 80% alcohol liquid 
Assured Bio Labs, 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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Hand Sanitizer Spray 1 Gallon

Active ingredient

Ethyl alcohol 80% v/v

Purpose

Antiseptic

Use

Hand sanitizer to decrease bacteria on the skin that could cause disease. For use when soap and water are not available.

Warnings

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

Do not use

• on 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 and lasts.

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

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

• Do not store above 115°F
• May discolor some fabrics.
• May damage wood finishes or plastics.

Inactive ingredients

Fragrance, glycerin, isopropyl alcohol, purified water

Package Label - Principal Display Panel

3785 mL NDC: 79334-002-02

ASSURED BIO INFECTION PROTECTION HAND SANITIZER 
80% alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79334-002(NDC: 75029-029)
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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79334-002-02	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/30/2020	12/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/30/2020	12/30/2020

Labeler - Assured Bio Labs, LLC (965552503)

Revised: 9/2022

Document Id: e8a86ae8-319a-5949-e053-2a95a90a8e6f

34390-5

Set id: b2bd1bb3-faf7-5694-e053-2995a90a2527

Version: 2

Effective Time: 20220914