Handsoap

BENZALKONIUM CHLORIDE TOPICAL HUMAN OTC DRUG

Handsoap is an FDA drug label for the active ingredient BENZALKONIUM CHLORIDE manufactured by CVS Pharmacy Inc. 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 20260520.

Generic name
BENZALKONIUM CHLORIDE
Manufacturer
CVS Pharmacy Inc.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
51316-705
Application
505G(a)(3)
Label effective
20260520

About this product

Handsoap is an FDA-registered drug product whose active ingredient is BENZALKONIUM CHLORIDE. It is labelled by CVS Pharmacy Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 51316-705, application 505G(a)(3), label effective 20260520. 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: helps eliminate. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Benzalkonium Chloride

Indications & Usage

Helps eliminate bacteria on the skin

Dosage & Administration

Apply onto dry hands, work into a lather, rinse and dry throughly.

Warnings

For external use only Avoid contact with eyes, If this occurs, rinse throughly with water. Stop use and ask a doctor if irritation or redness develops and lasts In case of accidental ingestion, seek medical attention or contact a poison control centre immediately.

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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

1 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-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

Frequently asked questions

What is Handsoap used for?
Helps eliminate bacteria on the skin

Who makes Handsoap?
CVS Pharmacy Inc. is the labeler of record for Handsoap. 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 Handsoap 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 Handsoap 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 Handsoap been recalled?
1 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.