NDC 81133-010 Q Shield Hand

Benzalkonium Chloride

NDC Product Code 81133-010

NDC 81133-010-05

Package Description: 50 mL in 1 BOTTLE, PUMP

NDC 81133-010-55

Package Description: 550 mL in 1 BOTTLE, PUMP

NDC Product Information

Q Shield Hand with NDC 81133-010 is a a human over the counter drug product labeled by Axenic Health Solutions, Inc.. The generic name of Q Shield Hand is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Axenic Health Solutions, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Q Shield Hand Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Axenic Health Solutions, Inc.
Labeler Code: 81133
FDA Application Number: part333E What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-22-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Q Shield Hand Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Benzalkonium Chloride 0.13%

Otc - Purpose

Hand and skin Antiseptic

Indications & Usage

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


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 woundsSerious 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: contact@axenic.com

* Please review the disclaimer below.