KLEENEX Foam Hand Sanitizer

BENZALKONIUM CHLORIDE TOPICAL HUMAN OTC DRUG

KLEENEX Foam Hand Sanitizer is an FDA drug label for the active ingredient BENZALKONIUM CHLORIDE manufactured by Kimberly-Clark 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 20260429.

Generic name
BENZALKONIUM CHLORIDE
Manufacturer
Kimberly-Clark
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
55118-701
Application
M003
Label effective
20260429

About this product

KLEENEX Foam Hand Sanitizer is an FDA-registered drug product whose active ingredient is BENZALKONIUM CHLORIDE. It is labelled by Kimberly-Clark taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 55118-701, application M003, label effective 20260429. 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: personal hand, hygiene help, spread bacteria. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Benzalkonium Chloride 0.13%w/w

Indications & Usage

Use For personal hand hygiene to help prevent the spread of bacteria

Dosage & Administration

Directions For adults and children over 2 years old. Lather in hands with water for at least 30 seconds. Rinse well. Children under the age of 6 should be supervised by an adult when using this product. For occasional and personal domestic use.

Warnings

Warnings For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation or redness develops. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact Poison Control right away.

More products with the same ingredient

BENZALKONIUM CHLORIDE

24 7 life by 7 Eleven Antibacterial HAND WIPES

7-ELEVEN, INC. View label

ACTIVE WIPES

Hangzhou Yida Technology Co., Ltd. View label

AEROAID

Aero Healthcare US LLC View label

ALTA ANTIBACTERIAL HAND WIPES

Alta Sales Inc View label

Alcohol Free Foaming Hand Sanitizer

Betco Corporation, Ltd. View label

Alcohol Free Hand Sanitizer

NANTONG HAIYIWEI TEXTILE CO., LTD. View label

Alcohol Free Hand Sanitizer

FULLER INDUSTRIES, INC View label

Amazon Basics Citrus Scent Antibacterial Hand Wipes

Amazon.com Services LLC View label

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

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.

RecallProductFirmClassStatusReported
D-0319-2021 Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199 Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5 UPC 0 36000 91592 1 Kimberly-Clark Corporation Class II Terminated 20210414
D-1414-2012 Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076 Kimberly-Clark Corporation Class II Terminated 20120718
D-1415-2012 Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, Distributed by Kimberly Clark, LLC, Roswell, GA 30076 Kimberly-Clark Corporation Class II Terminated 20120718

Frequently asked questions

What is KLEENEX Foam Hand Sanitizer used for?
Use For personal hand hygiene to help prevent the spread of bacteria

Who makes KLEENEX Foam Hand Sanitizer?
Kimberly-Clark is the labeler of record for KLEENEX Foam Hand Sanitizer. 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 KLEENEX Foam Hand Sanitizer 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 KLEENEX Foam Hand Sanitizer 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 KLEENEX Foam Hand Sanitizer 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.