ANTISEPTIC WIPE
ANTISEPTIC WIPE is an FDA drug label for the active ingredient BENZALKONIUM CHLORIDE WIPE manufactured by Diamond Wipes International 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 20260701.
- Generic name
- BENZALKONIUM CHLORIDE WIPE
- Manufacturer
- Diamond Wipes International
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 64709-108
- Application
- 505G(a)(3)
- Label effective
- 20260701
About this product
ANTISEPTIC WIPE is an FDA-registered drug product whose active ingredient is BENZALKONIUM CHLORIDE WIPE. It is labelled by Diamond Wipes International taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 64709-108, application 505G(a)(3), label effective 20260701. 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 WIPE are most often described in connection with: hand sanitizing, decrease bacteria. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses ■for hand sanitizing to decrease bacteria on ■safe for repeated
Dosage & Administration
Directions ■thoroughly wipe hands for approximately 30 seconds ■throw use wipe in trash, do not flush
Warnings
Warnings For external use only When using this product avoid contact with eyes. If in eyes, flush thoroughly with water
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.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0630-2018 | WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA 91710, UPC 7 66670 03988 6. | Diamond Wipes International, Inc. | Class II | Terminated | 20180425 |
| D-0629-2018 | ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet Brands, Fort Lauderdale, FL 33316, UPC 8 54049 00358 0. | Diamond Wipes International, Inc. | Class II | Terminated | 20180425 |
| D-0365-2026 | Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort Meyers, FL, 33967, NDC 47682-122-33. | ACME UNITED CORPORATION | Class II | Ongoing | 20260311 |
| D-0374-2026 | Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73 | ACME UNITED CORPORATION | Class II | Ongoing | 20260311 |
| D-1675-2012 | ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA | Dukal Corp. | Class II | Terminated | 20120926 |
Frequently asked questions
What is ANTISEPTIC WIPE used for?
Uses ■for hand sanitizing to decrease bacteria on ■safe for repeated
Who makes ANTISEPTIC WIPE?
Diamond Wipes International is the labeler of record for ANTISEPTIC WIPE.
What form does ANTISEPTIC WIPE 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 ANTISEPTIC WIPE 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.
Has ANTISEPTIC WIPE 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.