Hand Sanitizer by Omni Distributors, LLC / Boya Biotechnology Company Limited

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Omni Distributors, LLC, Boya Biotechnology Company Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- ethyl alcohol 75% liquid 
Omni Distributors, 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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Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 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. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

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

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

500 mL NDC: 79624-002-01

HAND SANITIZER 
ethyl alcohol 75% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79624-002
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER 940 (UNII: 4Q93RCW27E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79624-002-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	05/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	05/19/2023

Labeler - Omni Distributors, LLC (117528966)

Establishment
Name	Address	ID/FEI	Business Operations
Boya Biotechnology Company Limited		403701144	manufacture(79624-002)

Revised: 1/2022

Document Id: d4680a4e-47d1-3d36-e053-2a95a90a2b24

34390-5

Set id: ab8e02fd-aac9-731c-e053-2a95a90a7bf4

Version: 2

Effective Time: 20220117