Antiseptic Hand

CHLOROXYLENOL TOPICAL HUMAN OTC DRUG

Antiseptic Hand is an FDA drug label for the active ingredient CHLOROXYLENOL manufactured by Image Supply, Inc. 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 20260511.

Generic name
CHLOROXYLENOL
Manufacturer
Image Supply, Inc.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
16496-544
Application
M003
Label effective
20260511

About this product

Antiseptic Hand is an FDA-registered drug product whose active ingredient is CHLOROXYLENOL. It is labelled by Image Supply, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 16496-544, application M003, label effective 20260511. It is one of 45 FDA drug label records sharing the active ingredient CHLOROXYLENOL. 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 CHLOROXYLENOL are most often described in connection with: drug facts, box otc-indications, usage section, hand-washing decrease. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Drug Facts Box OTC-Active Ingredient Section Chloroxylenol 0.3%

Indications & Usage

Drug Facts Box OTC-Indications & Usage Section for hand-washing to decrease bacteria on the skin

Dosage & Administration

Drug Facts Box OTC-Dosage & Administration Section wet hands and forearms apply 5 milliliters (teaspoonful) or palmful to hands and forearms scrub thoroughly for 1 minute and rinse

Warnings

Drug Facts Box OTC-Warnings Section For external use only

More products with the same ingredient

CHLOROXYLENOL

1012 Antimicrobial

ABC Compounding Co., Inc. View label

ASEPSO ANTISEPTIC ORIGINAL

CODAA Switzerland AG View label

Antibacterial Lotions Skin Cleanser

Betco Corporation, Ltd. View label

Antimicrobial Hand Wash

Henry Schein, Inc. View label

Antimicrobial Hand Wash

Henry Schein, Inc. View label

Asepso Aloe Scented Antiseptic

CODAA Switzerland AG View label

Asepso Fresh Scented Antiseptic

CODAA SWITZERLAND AG View label

How products containing CHLOROXYLENOL compare

FDA lists 45 drug label records with CHLOROXYLENOL 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
— — ABC Compounding Co., Inc. 6
— — CODAA SWITZERLAND AG 4
— — Avro Enterprises LLC 2
— — CODAA Switzerland AG 2
— — Fuller Industries, Inc 2

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.

RecallProductFirmClassStatusReported
D-0089-2025 Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509 Midlab Incorporated Class II Ongoing 20241211
D-0254-2023 Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00050 9 Frenda Corporation Class II Terminated 20230208
D-0796-2021 Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO. Grupo Asimex de Mexico SA de CV Class II Terminated 20210922
D-0795-2021 Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO. Grupo Asimex de Mexico SA de CV Class I Terminated 20210922
D-0361-2021 Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.UPC 7 53727 26257 1 NDC: 64009-336-85 Spartan Chemical Co Inc Class II Terminated 20210421

Frequently asked questions

What is Antiseptic Hand used for?
Drug Facts Box OTC-Indications & Usage Section for hand-washing to decrease bacteria on the skin

Who makes Antiseptic Hand?
Image Supply, Inc. is the labeler of record for Antiseptic Hand. 45 FDA label records share the active ingredient CHLOROXYLENOL, 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 Antiseptic Hand 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 Hand 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 CHLOROXYLENOL?
Yes. 45 FDA drug label records list CHLOROXYLENOL 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 Antiseptic Hand 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.