Q Shield Hand

Manufacturer
Axenic Health Solutions, Inc. | Filltech USA, LLC
Effective date
2020-12-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:46

Label at a glance#

ProductQ Shield Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Hand and skin Antiseptic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

* If you are allergic to any of our ingredients

* In you ears, mouth, or eyes

* If eye contact occurs, rinse thoroughly with water

OTC - ASK DOCTOR SECTION

Open wounds

Serious burns

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children should be supervised when using this product.

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.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

550 ml Label550 ml Label

50ml label50ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN1
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD1
1049254benzalkonium chloride 0.13 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81133-010-052023-01-30C16284748780-1f386c64a-1a37-0266-e053-dadaa90a7c1aDrug Facts
81133-010-552023-01-30C16284748780-1f386c64a-1a37-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81133-010-05Q Shield Hand50 mL in 1 BOTTLE, PUMPLIQUID501
81133-010-55Q Shield Hand550 mL in 1 BOTTLE, PUMPLIQUID5501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81133-010Q SHIELD HAND (BENZALKONIUM CHLORIDE) LIQUID [AXENIC HEALTH SOLUTIONS, INC.]1Legacy NDC, 2 package rows20201224_b710050a-b158-2592-e053-2995a90ad659.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81133-01081133-010-05, 81133-010-55

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b710050a-b159-2592-e053-2995a90ad659b710050a-b158-2592-e053-2995a90ad6592020-12-22WarningsExact identifier
spl id: b710050a-b159-2592-e053-2995a90ad659
spl set id: b710050a-b158-2592-e053-2995a90ad659

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.