Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID b710050a-b158-2592-e053-2995a90ad659

Route

TOPICAL

Published

Effective Date 2020-12-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Dimethyloctadecyl(3-(trimethoxysilyl)propyl)ammonium Chloride Alcohol Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-12-22

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

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

Dosage and Administration

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

Description

Benzalkonium Chloride 0.13%

Section 50565-1

Children should be supervised when using this product.

Section 50566-9

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

Section 50569-3

Open wounds

Serious burns

Section 50570-1

* If you are allergic to any of our ingredients

* In you ears, mouth, or eyes

* If eye contact occurs, rinse thoroughly with water

Section 51727-6

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

Section 51945-4

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

FDA Registered.

Made in the USA

NDC: 81133-010-XX

Section 53413-1

Call: 833-747-8283 or e-mail: [email protected]

Section 55105-1

Hand and skin Antiseptic

Section 55106-9

Benzalkonium Chloride 0.13%

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Children should be supervised when using this product.

Section 50566-9 (50566-9)

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

Section 50569-3 (50569-3)

Open wounds

Serious burns

Section 50570-1 (50570-1)

* If you are allergic to any of our ingredients

* In you ears, mouth, or eyes

* If eye contact occurs, rinse thoroughly with water

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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

FDA Registered.

Made in the USA

NDC: 81133-010-XX

Section 53413-1 (53413-1)

Call: 833-747-8283 or e-mail: [email protected]

Section 55105-1 (55105-1)

Hand and skin Antiseptic

Section 55106-9 (55106-9)

Benzalkonium Chloride 0.13%

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE", "unii": "IQ36O85WQ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Hand and Skin Antiseptic to help decrease pathogens (germs) on the skin", "34068-7": "Apply 3 pumps onto clean, dry hands. Ensure covergae on skin and under fingernails.", "34071-1": "For external use only", "50565-1": "Children should be supervised when using this product.", "50566-9": "Redness or skin irritation develop after use, and persists for more than 72 hours.", "50569-3": "Open wounds Serious burns", "50570-1": "* If you are allergic to any of our ingredients * In you ears, mouth, or eyes * If eye contact occurs, rinse thoroughly with water", "51727-6": "1-Octadecyldimethyl (3-Trimethoxysilylpropyl) ammonium chloride, deionized water, and ethanol", "51945-4": "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", "53413-1": "Call: 833-747-8283 or e-mail: contact@axenic.com", "55105-1": "Hand and skin Antiseptic", "55106-9": "Benzalkonium Chloride 0.13%"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:12.034358 · Updated: 2026-03-14T22:59:04.734496