Lidocaine Menthol Pain Relief

LIDOCAINE, MENTHOL TOPICAL HUMAN OTC DRUG

Lidocaine Menthol Pain Relief is an FDA drug label for the active ingredient LIDOCAINE, MENTHOL manufactured by Amerisource Bergen 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 20260526.

Generic name
LIDOCAINE, MENTHOL
Manufacturer
Amerisource Bergen
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
46122-574
Application
M017
Label effective
20260526

About this product

Lidocaine Menthol Pain Relief is an FDA-registered drug product whose active ingredient is LIDOCAINE, MENTHOL. It is labelled by Amerisource Bergen taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 46122-574, application M017, label effective 20260526. It is one of 13 FDA drug label records sharing the active ingredient LIDOCAINE, MENTHOL. 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 LIDOCAINE, MENTHOL are most often described in connection with: temporary relief. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Lidocaine 4% Menthol 1%

Indications & Usage

USES For the temporary relief of pain

Dosage & Administration

DIRECTIONS Adults and children 12 years of age and over: Adults and children 2 years of age and over: Clean and dry affected area, free of lotions, ointments and creams Carefully remove backing from patch starting at a corner Apply sticky side of patch to affected area Do not use more than one patch in a 12 hour period Maximum 2 patches per day Discard patch after single use Children under 2 years of age: Do not use, ask a doctor

Warnings

WARNINGS For External use only. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. ■over raw surfaces or blistered areas If pregnant or breast feeding ask a health professional before use. WHEN USING: avoid contact with the eyes do not use more than one patch on your body at a time Stop use and consult a doctor if skin irritation develops condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days

More products with the same ingredient

LIDOCAINE, MENTHOL

Biofreeze Ultraflex Plus

Reckitt Benckiser LLC View label

Careland Lidocaine Plus Menthol Pain Relieving

Planet (Anhui) Pharmaceutical Co., Ltd View label

Careland Lidocaine Plus Menthol Pain Relieving Gel Patches

Planet (Anhui) Pharmaceutical Co., Ltd. View label

Cold and Heat Lidocaine Patch Plus Menthol

Cardinal Health, 110 dba LEADER View label

Lidozen

Proficient Rx LP View label

Lidozen Patch

Proficient Rx LP View label

MAXIMUM STRENGTH Lidocaine Plus Menthol

ARMY AND AIR FORCE EXCHANGE SERVICE View label

How products containing LIDOCAINE, MENTHOL compare

FDA lists 13 drug label records with LIDOCAINE, MENTHOL 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
— — Kareway Product, Inc. 2
— — Proficient Rx LP 2
— — ARMY AND AIR FORCE EXCHANGE SERVICE 1
— — ASCLEMED USA INC. 1
— — Amerisource Bergen 1

Recall and safety notices

2 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-1066-2013 Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22 AmeriSource Bergen Class II Terminated 20131009
D-1065-2013 Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4495-22 AmeriSource Bergen Class II Terminated 20131009

Frequently asked questions

What is Lidocaine Menthol Pain Relief used for?
USES For the temporary relief of pain

Who makes Lidocaine Menthol Pain Relief?
Amerisource Bergen is the labeler of record for Lidocaine Menthol Pain Relief. 13 FDA label records share the active ingredient LIDOCAINE, MENTHOL, 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 Lidocaine Menthol Pain Relief 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 Lidocaine Menthol Pain Relief 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 LIDOCAINE, MENTHOL?
Yes. 13 FDA drug label records list LIDOCAINE, MENTHOL 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 Lidocaine Menthol Pain Relief been recalled?
2 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.