Otc - Active Ingredient
Benzalkonium Chloride 0.13%
Q Shield Hand
FDA Label NDC 81133-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Axenic Health Solutions, Inc. for the product Q Shield Hand (NDC 81133-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Hand and skin Antiseptic
Indications & Usage
Hand and Skin Antiseptic to help decrease pathogens (germs) on the skin
Warnings
For external use only
Otc - Do Not Use
* 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
Open wounds
Serious burns
Otc - Stop Use
Redness or skin irritation develop after use, and persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
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
Otc - Questions
Call: 833-747-8283 or e-mail: [email protected]
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 Label (Qshield Label Gold 550ml Rev 1204 Outlines)
50ml Label (Qshield Label Gold 50ml Rev 1204 Outlines)
* Please review the disclaimer below.
