berkley jensen
berkley jensen is an FDA drug label for the active ingredient BENZALKONIUM CHLORIDE manufactured by Apollo Health and Beauty Care 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 20260508.
- Generic name
- BENZALKONIUM CHLORIDE
- Manufacturer
- Apollo Health and Beauty Care
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 63148-350
- Application
- 505G(a)(3)
- Label effective
- 20260508
About this product
berkley jensen is an FDA-registered drug product whose active ingredient is BENZALKONIUM CHLORIDE. It is labelled by Apollo Health and Beauty Care taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 63148-350, application 505G(a)(3), label effective 20260508. 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, bacteria hands. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses Helps eliminate bacteria on hands.
Dosage & Administration
Directions Apply a small amount onto wet hands Work into a lather and rinse
Warnings
Warnings For external use only When using this product Avoid contact with eyes. If this occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation or redness develops and lasts Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison center immediately.
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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
2 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-0333-2022 | berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 150 count bottle, Made in the Czech Republic, Distributed by: BJ's WHolesale Club 25 Research Drive Westborough, MA 01581 | Perrigo Company PLC | Class II | Terminated | 20220112 |
| D-1026-2020 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01; NDC Berkley Jensen: 68391-852-56; NDC: CVS Health: 59779-540-01; NDC DG Health: 55910-011-01; NDC Kirkland: 63981-852-56; NDC Kroger: 30142-600-56; NDC Meijer: 41250-852-01; NDC Rite Aid: 11822-0852-4; NDC Walgreens: 0363-0852-01 | Perrigo Company PLC | Class II | Terminated | 20200325 |
Frequently asked questions
What is berkley jensen used for?
Uses Helps eliminate bacteria on hands.
Who makes berkley jensen?
Apollo Health and Beauty Care is the labeler of record for berkley jensen. 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 berkley jensen 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 berkley jensen 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 berkley jensen been recalled?
2 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.