COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF

MENTHOL TOPICAL HUMAN OTC DRUG

COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF is an FDA drug label for the active ingredient MENTHOL manufactured by NATURAL ESSENTIALS, 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 20180927.

Generic name
MENTHOL
Manufacturer
NATURAL ESSENTIALS, INC.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
66902-114
Application
part348
Label effective
20180927

About this product

COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by NATURAL ESSENTIALS, INC. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 66902-114, application part348, label effective 20180927. It is one of 193 FDA drug label records sharing the active ingredient 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 MENTHOL are most often described in connection with: temporary relief, 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 INGREDIENTS NATURAL Menthol USP 3.7%

Indications & Usage

*USES: For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Dosage & Administration

DIRECTIONS: Adults and children 12 years and older Apply and gently massage painful joints and/or muscles. Repeat as needed no more than 4 times a day. Wash hands after each use with cold water

Warnings

WARNINGS: Use only as directed. For external use only If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. Avoid contact with eyes or mucous membranes Pregnancy - Breast Feeding Warning: If pregnant or breast feeding, ask a physician before use. Do not use with other topical products Do not use with heating devices Do not use on open wounds, damaged or irritated skin Keep away from excessive heat or open flame. KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN. Accidental ingestion: Seek professional help and contact Poison Control immediately.

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How products containing MENTHOL compare

FDA lists 193 drug label records with 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
— — Reckitt Benckiser LLC 23
— — Mondelez Global LLC 6
— — BLUE SPRING WELLNESS, L.L.C. 5
— — Shanghai Chuangshi Medical Technology (Group) Co., Ltd. 5
— — Bestco 4

Frequently asked questions

What is COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF used for?
*USES: For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Who makes COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF?
NATURAL ESSENTIALS, INC. is the labeler of record for COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF. 193 FDA label records share the active ingredient 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 COLD LEAF NUTRITION MUSCLE AND JOINT 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 COLD LEAF NUTRITION MUSCLE AND JOINT 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 MENTHOL?
Yes. 193 FDA drug label records list 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 COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.