Q SHIELD HAND- benzalkonium chloride liquid

Q Shield Hand by

Drug Labeling and Warnings

Q Shield Hand by is a Otc medication manufactured, distributed, or labeled by Axenic Health Solutions, Inc., Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride 0.13%

PURPOSE

Hand and skin Antiseptic

INDICATIONS & USAGE

Hand and Skin Antiseptic to help decrease pathogens (germs) on the skin

WARNINGS

For external use only

* If you are allergic to any of our ingredients

* In you ears, mouth, or eyes

* If eye contact occurs, rinse thoroughly with water

Open wounds

Serious burns

Redness or skin irritation develop after use, and persists for more than 72 hours.

Children should be supervised when using this product.

DOSAGE & ADMINISTRATION

Apply 3 pumps onto clean, dry hands. Ensure covergae on skin and under fingernails.

INACTIVE INGREDIENT

1-Octadecyldimethyl (3-Trimethoxysilylpropyl) ammonium chloride, deionized water, and ethanol

QUESTIONS

Call: 833-747-8283 or e-mail: contact@axenic.com

PRINCIPAL DISPLAY PANEL

Axenic Q Shield

Benzalkonium Chloride Formula

Hand Sanitizer

Kills 99.9% of Germs and Bacteria on Hands

Distributed by:

Axenic Health Solutions

5700 Terryson Pkwy, Suite #300 Plano, TX 75024

(C)2020. All rrights Researved.

FDA Registered.

Made in the USA

NDC: 81133-010-XX

INGREDIENTS AND APPEARANCE

Q SHIELD HAND 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81133-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81133-010-05	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/22/2020
2	NDC: 81133-010-55	550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/22/2020

Labeler - Axenic Health Solutions, Inc. (117556611)

Registrant - Axenic Health Solutions, Inc. (117556611)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		926433855	manufacture(81133-010) , pack(81133-010) , label(81133-010) , analysis(81133-010)