Q SHIELD HAND- benzalkonium chloride liquid 
Axenic Health Solutions, 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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Drug Facts

Benzalkonium Chloride 0.13%

Hand and skin Antiseptic

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

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.

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

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

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

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

550 ml Label

50ml label

Q SHIELD HAND 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81133-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81133-010-0550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/22/2020
2NDC:81133-010-55550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/22/2020
Labeler - Axenic Health Solutions, Inc. (117556611)
Registrant - Axenic Health Solutions, Inc. (117556611)
Establishment
NameAddressID/FEIBusiness Operations
Filltech USA, LLC926433855manufacture(81133-010) , pack(81133-010) , label(81133-010) , analysis(81133-010)

Revised: 12/2020
Document Id: b710050a-b159-2592-e053-2995a90ad659
Set id: b710050a-b158-2592-e053-2995a90ad659
Version: 1
Effective Time: 20201222
 
Axenic Health Solutions, Inc.