Benzalkonium Chloride
Benzalkonium Chloride is an FDA drug label for the active ingredient BENZALKONIUM CHLORIDE TOWELETTES manufactured by Trifecta Pharmaceuticals USA LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260820.
- Generic name
- BENZALKONIUM CHLORIDE TOWELETTES
- Manufacturer
- Trifecta Pharmaceuticals USA LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 69396-186
- Application
- M003
- Label effective
- 20260820
About this product
Benzalkonium Chloride is an FDA-registered drug product whose active ingredient is BENZALKONIUM CHLORIDE TOWELETTES. It is labelled by Trifecta Pharmaceuticals USA LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 69396-186, application M003, label effective 20260820. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing BENZALKONIUM CHLORIDE TOWELETTES are most often described in connection with: towelette help, risk skin. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Use Towelette to help prevent the risk of skin infection.
Dosage & Administration
Directions Tear open packet Unfold and clean the affected area discard after single use
Warnings
Warnings For external use only: Do Not insert into the Vagina
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0699-2026 | Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670, | Blaine Labs Inc | Class II | Ongoing | 20260708 |
| D-0693-2026 | TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01. | Blaine Labs Inc | Class II | Ongoing | 20260708 |
| D-0692-2026 | Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02. | Blaine Labs Inc | Class I | Ongoing | 20260708 |
| D-0509-2026 | Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950 | Water-Jel Technologies, LLC | Class III | Ongoing | 20260506 |
| D-0376-2026 | Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04. | ACME UNITED CORPORATION | Class II | Ongoing | 20260311 |
Frequently asked questions
What is Benzalkonium Chloride used for?
Use Towelette to help prevent the risk of skin infection.
Who makes Benzalkonium Chloride?
Trifecta Pharmaceuticals USA LLC is the labeler of record for Benzalkonium Chloride.
What form does Benzalkonium Chloride come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Benzalkonium Chloride prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Benzalkonium Chloride been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.