Antibacterial Foaming Hand
Antibacterial Foaming Hand is an FDA drug label for the active ingredient BENZALKONIUM CHLORIDE manufactured by Cintas 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 20260605.
- Generic name
- BENZALKONIUM CHLORIDE
- Manufacturer
- Cintas
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 42961-615
- Application
- 505G(a)(3)
- Label effective
- 20260605
About this product
Antibacterial Foaming Hand is an FDA-registered drug product whose active ingredient is BENZALKONIUM CHLORIDE. It is labelled by Cintas taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 42961-615, application 505G(a)(3), label effective 20260605. 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
Indications & Usage
Use For hand washing to decrease bacteria on skin. Repeat as neeeded.
Dosage & Administration
Directions Wet hands, place hands under the dispenser to allow 0.4 mL 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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View labelHow 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 form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | 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
3 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-1310-2019 | ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6/1000ML pouches per case, 5063-OS1000; d) INOFOAM Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6-1000ml pouches per case, 5063-FL1000, Inopak LTD., 24 Executive Parkway, Ringwood, NJ 07456. | Inopak Ltd | Class II | Terminated | 20190605 |
| D-0864-2018 | Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ | Inopak Ltd | Class II | Terminated | 20180620 |
| D-0002-2018 | Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02 | Inopak Ltd | Class II | Terminated | 20171011 |
Frequently asked questions
What is Antibacterial Foaming Hand used for?
Use For hand washing to decrease bacteria on skin. Repeat as neeeded.
Who makes Antibacterial Foaming Hand?
Cintas is the labeler of record for Antibacterial Foaming Hand. 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 Foaming Hand 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 Foaming Hand 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 Foaming Hand been recalled?
3 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.