MAXIM Assure
MAXIM Assure is an FDA drug label for the active ingredient PCMX, DISHWASHING AND HAND SOAP manufactured by Midlab Incorporated 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 20260819.
- Generic name
- PCMX, DISHWASHING AND HAND SOAP
- Manufacturer
- Midlab Incorporated
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 70542-701
- Application
- 505G(a)(3)
- Label effective
- 20260819
About this product
MAXIM Assure is an FDA-registered drug product whose active ingredient is PCMX, DISHWASHING AND HAND SOAP. It is labelled by Midlab Incorporated taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 70542-701, application 505G(a)(3), label effective 20260819. It is one of 2 FDA drug label records sharing the active ingredient PCMX, DISHWASHING AND HAND SOAP. 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 PCMX, DISHWASHING AND HAND SOAP are most often described in connection with: handwash help, decrease bacteria. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Use Handwash to help decrease bacteria on the skin.
Dosage & Administration
Directions Apply a small amount of product to wet hands, work into lather for 30 seconds, and rinse thoroughly. Children under 6 years of age should be supervised when using this product.
Warnings
Warnings For external use only. Do Not Use in the eyes. In case of contact, immediately fush eyes with water. Stop use and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
How products containing PCMX, DISHWASHING AND HAND SOAP compare
FDA lists 2 drug label records with PCMX, DISHWASHING AND HAND SOAP 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 |
|---|---|---|---|
| — | — | Cyan Labs, S.A. de C.V. | 1 |
| — | — | Midlab Incorporated | 1 |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
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-0090-2025 | ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139 | Midlab Incorporated | Class II | Ongoing | 20241211 |
| D-0091-2025 | Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339 | Midlab Incorporated | Class II | Ongoing | 20241211 |
| D-0087-2025 | MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303 | Midlab Incorporated | Class II | Ongoing | 20241211 |
| 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-0088-2025 | boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015 | Midlab Incorporated | Class II | Ongoing | 20241211 |
Frequently asked questions
What is MAXIM Assure used for?
Use Handwash to help decrease bacteria on the skin.
Who makes MAXIM Assure?
Midlab Incorporated is the labeler of record for MAXIM Assure. 2 FDA label records share the active ingredient PCMX, DISHWASHING AND HAND SOAP, 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 MAXIM Assure 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 MAXIM Assure 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 PCMX, DISHWASHING AND HAND SOAP?
Yes. 2 FDA drug label records list PCMX, DISHWASHING AND HAND SOAP 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 MAXIM Assure 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.