HAND SANITIZER GEL- alcohol liquid

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Nine Mile Health, LLC, Economy Polymers. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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

Questions?

www.ninemilehealth.com

SPL UNCLASSIFIED SECTION

Manufactured by Economy Polymers and Chemicals
435 E Anderson Road, Houston, TX 77047

Distributed by Nine Mile Health, LLC
5500 Greenwood Plaza Blvd., Suite 130, Greenwood Village, CO 80111

PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label

NINE MILE
HEALTH

GEL

ALCOHOL ANTISEPTIC 80%
TOPICAL SOLUTION

1
GALLON
(3785 mL)
| NON-STERILE SOLUTION

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78697-128
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: 78697-128-01	3785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	03/30/2020

Labeler - Nine Mile Health, LLC (131106596)

Establishment
Name	Address	ID/FEI	Business Operations
Economy Polymers		008087603	MANUFACTURE(78697-128)