Softsoap Antibacterial Clean and Protect Cool Splash

BENZALKONIUM CHLORIDE TOPICAL HUMAN OTC DRUG

Softsoap Antibacterial Clean and Protect Cool Splash is an FDA drug label for the active ingredient BENZALKONIUM CHLORIDE manufactured by COLGATE PALMOLIVE COMPANY 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 20260820.

Generic name
BENZALKONIUM CHLORIDE
Manufacturer
COLGATE PALMOLIVE COMPANY
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
35000-254
Application
505G(a)(3)
Label effective
20260820

About this product

Softsoap Antibacterial Clean and Protect Cool Splash is an FDA-registered drug product whose active ingredient is BENZALKONIUM CHLORIDE. It is labelled by COLGATE PALMOLIVE COMPANY taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 35000-254, application 505G(a)(3), label effective 20260820. 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

Active ingredient Benzalkonium Chloride 0.13%

Indications & Usage

Use helps eliminate bacteria on hands

Dosage & Administration

Directions wash hands and rinse

Warnings

Warnings For external use only. When using this product, avoid contact with eyes. In case of contact, flush with water. Keep out of reach of children, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

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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

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.

RecallProductFirmClassStatusReported
D-1084-2023 hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distributed by Hello Products LLC, Montclair, NJ 07042, UPC 8 19156 02026 4 (carton), 12-count case GTIN: 20819156020268; strawberry tubes also sold in Strawberry 3-pack overwrap UPC 8 19156 02349 4, UPC 10819156023491 case; in the variety 3-pack of Strawberry + Unicorn + Grape UPC 8 19156 02332 6, UPC 10819156023323 case; and in a 24-count Toothpaste Floorstand, UPC 819156020684 (case). Colgate Palmolive Company Class II Terminated 20230823

Frequently asked questions

What is Softsoap Antibacterial Clean and Protect Cool Splash used for?
Use helps eliminate bacteria on hands

Who makes Softsoap Antibacterial Clean and Protect Cool Splash?
COLGATE PALMOLIVE COMPANY is the labeler of record for Softsoap Antibacterial Clean and Protect Cool Splash. 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 Softsoap Antibacterial Clean and Protect Cool Splash 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 Softsoap Antibacterial Clean and Protect Cool Splash 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 Softsoap Antibacterial Clean and Protect Cool Splash 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.