Hand Sanitizer Spray 5 oz

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 spray 
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 5 oz

Active ingredient

Ethyl alcohol 80% v/v

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

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

• Do not use in eyes. In case of contact with eyes, rinse with water.

Stop use and ask a doctor if redness and irritation develop and persist.

Keep out of reach of children. If swallowed, get medical help.

Directions

• Wet hands throughly with product and allow to dry without wiping.

Other information

• Do not store above 115°F

Inactive ingredients

Fragrance, glycerin, isopropyl alcohol, purified water

Package Label - Principal Display Panel

148 mL NDC: 79334-002-01

ASSURED BIO INFECTION PROTECTION HAND SANITIZER 
80% alcohol spray

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
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79334-002-01	148 mL in 1 BOTTLE, SPRAY; 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: e8a86606-151e-30e0-e053-2a95a90a8bee

34390-5

Set id: b2c2718b-4763-f9f0-e053-2a95a90aaab4

Version: 2

Effective Time: 20220914