Obstetrical Towelette
Obstetrical Towelette is an FDA drug label for the active ingredient BENZALKONIUM CHLORIDE manufactured by Jianerkang Medical Co., Ltd 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 20231023.
- Generic name
- BENZALKONIUM CHLORIDE
- Manufacturer
- Jianerkang Medical Co., Ltd
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 34645-0015
- Application
- M003
- Label effective
- 20231023
About this product
Obstetrical Towelette is an FDA-registered drug product whose active ingredient is BENZALKONIUM CHLORIDE. It is labelled by Jianerkang Medical Co., Ltd taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 34645-0015, application M003, label effective 20231023. 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: first aid, antiseptic 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 First aid antiseptic to help reduce the risk of skin infection.
Dosage & Administration
Directions Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandaged. If bandaged, let dry first.
Warnings
For External Use Only Do Not Use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor. Stop Use and consult doctor: if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor. 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
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.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0369-2026 | Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02 | ACME UNITED CORPORATION | Class II | Ongoing | 20260311 |
Frequently asked questions
What is Obstetrical Towelette used for?
Use First aid antiseptic to help reduce the risk of skin infection.
Who makes Obstetrical Towelette?
Jianerkang Medical Co., Ltd is the labeler of record for Obstetrical Towelette. 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 Obstetrical Towelette 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 Obstetrical Towelette 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 Obstetrical Towelette 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.