Maximum Strength Pain Relief

MENTHOL CREAM TOPICAL HUMAN OTC DRUG

Maximum Strength Pain Relief is an FDA drug label for the active ingredient MENTHOL CREAM manufactured by OWELL NATURALS LLC 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 20260604.

Generic name
MENTHOL CREAM
Manufacturer
OWELL NATURALS LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
83570-004
Application
M017
Label effective
20260604

About this product

Maximum Strength Pain Relief is an FDA-registered drug product whose active ingredient is MENTHOL CREAM. It is labelled by OWELL NATURALS LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 83570-004, application M017, label effective 20260604. 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 MENTHOL CREAM are most often described in connection with: temporarily relieves, minor aches, pains muscles, joints associated, simple backache, arthritis strains. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredient Menthol 8%

Indications & Usage

Uses Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage & Administration

Directions

Warnings

Warnings For external use only. Do not use on wounds or damaged skin. When using this product, avoid contact with eyes or mucous membranes. Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days.

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-0065-2025 THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 Unexo Life Sciences Private Limited Class II Terminated 20241204

Frequently asked questions

What is Maximum Strength Pain Relief used for?
Uses Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Who makes Maximum Strength Pain Relief?
OWELL NATURALS LLC is the labeler of record for Maximum Strength Pain Relief.

What form does Maximum Strength 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 Maximum Strength 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.

Has Maximum Strength Pain Relief 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.