PERSONAL DEFENSE HAND SANITIZER

PERSONAL DEFENSE HAND SANITIZER by

Drug Labeling and Warnings

PERSONAL DEFENSE HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by UNITED LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PERSONAL DEFENSE HAND SANITIZER- alcohol solution 
United Laboratories, Inc.

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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PERSONAL DEFENSE HAND SANITIZER

Drug Facts

Active ingredient[s]

Alcohol 80% v/v

Purpose

Antiseptic

Use[s]

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.

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

Manufactured and Sold Exclusively By:
UNITED LABORATORIES, INC.
320 37th Avenue St. Charles, IL 60174

PRINCIPAL DISPLAY PANEL - 18.9 L Pail Label

UNITED
MD SUPPLY™

United 664

PERSONAL DEFENSE
HAND SANITIZER
Alcohol Antiseptic 80%
Topical Solution

Hand Sanitizer
Non-sterile Solution

NET CONTENTS: 5 Gallons (18.9 L)

Manufactured and Sold Exclusively By:
UNITED LABORATORIES, INC.
320 37th Avenue St. Charles, IL 60174
1-800-323-2594 www.unitedlabsinc.com

PERSONAL DEFENSE HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63998-664
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)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63998-664-05	18900 mL in 1 PAIL; Type 0: Not a Combination Product	09/08/2021	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	09/08/2021	12/31/2021

Labeler - United Laboratories, Inc. (001759737)

Establishment
Name	Address	ID/FEI	Business Operations
United Laboratories, Inc.		001759737	MANUFACTURE(63998-664) , LABEL(63998-664)

Revised: 9/2021

Document Id: f7b95504-165b-4d2f-bd5f-eeaf9edb9583

34390-5

Set id: 5025f9d1-4298-411e-a71b-bb4a110f9e5d

Version: 3

Effective Time: 20210913