Antibacterial

BENZALKONIUM CHLORIDE TOPICAL HUMAN OTC DRUG

Antibacterial is an FDA drug label for the active ingredient BENZALKONIUM CHLORIDE manufactured by Rubbermaid Commercial Products 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 20260611.

Generic name
BENZALKONIUM CHLORIDE
Manufacturer
Rubbermaid Commercial Products LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
65321-031
Application
505G(a)(3)
Label effective
20260611

About this product

Antibacterial is an FDA-registered drug product whose active ingredient is BENZALKONIUM CHLORIDE. It is labelled by Rubbermaid Commercial Products LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 65321-031, application 505G(a)(3), label effective 20260611. It is one of 231 FDA drug label records sharing the active ingredient BENZALKONIUM CHLORIDE. 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 are most often described in connection with: hand washing, decrease bacteria, skin repeat. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredient 0.13% Benzalkonium Chloride

Indications & Usage

Use For hand washing to decrease bacteria on skin. Repeat as needed.

Dosage & Administration

Directions Wet hands, place hands under the dispenser to allow 0.8ml of hand wash to squirt into hands, wash thoroughly for at least 30 seconds, rinse hands thoroughly with potable water after washing.

Warnings

Warnings For external use only. When using this product avoid contact with eyes . In case of eye contact, flush with water. Stop use and ask a doctor, if irritation or redness persist. Do not ingest. Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

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How products containing BENZALKONIUM CHLORIDE compare

FDA lists 231 drug label records with BENZALKONIUM CHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — USA Broom LLC 28
— — Apollo Health and Beauty Care 11
— — Enviro Specialty Chemicals Inc 11
— — H E B 10
— — Jianerkang Medical Co., Ltd 7

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.

RecallProductFirmClassStatusReported
D-0363-2026 Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01 ACME UNITED CORPORATION Class II Ongoing 20260311
D-0364-2026 Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02 ACME UNITED CORPORATION Class II Ongoing 20260311
D-0088-2025 boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015 Midlab Incorporated Class II Ongoing 20241211
D-0090-2025 ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139 Midlab Incorporated Class II Ongoing 20241211
D-0092-2025 Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670 Midlab Incorporated Class II Ongoing 20241211

Frequently asked questions

What is Antibacterial used for?
Use For hand washing to decrease bacteria on skin. Repeat as needed.

Who makes Antibacterial?
Rubbermaid Commercial Products LLC is the labeler of record for Antibacterial. 231 FDA label records share the active ingredient BENZALKONIUM CHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Antibacterial 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 Antibacterial 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.

Are there other products containing BENZALKONIUM CHLORIDE?
Yes. 231 FDA drug label records list BENZALKONIUM CHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Antibacterial 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.