North Star Nutritionals Soothanol X3 Pain Relieving Drops

MENTHOL TOPICAL HUMAN OTC DRUG

North Star Nutritionals Soothanol X3 Pain Relieving Drops is an FDA drug label for the active ingredient MENTHOL manufactured by NEWMARKET HEALTH PRODUCTS, 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 20260521.

Generic name
MENTHOL
Manufacturer
NEWMARKET HEALTH PRODUCTS, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
50972-950
Application
M017
Label effective
20260521

About this product

North Star Nutritionals Soothanol X3 Pain Relieving Drops is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by NEWMARKET HEALTH PRODUCTS, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 50972-950, application M017, label effective 20260521. 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, muscle aches, joint pain, backaches arthritis, discomfort strains. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients Menthol 13% Purpose Topical Analgesic

Indications & Usage

Uses For temporary relief of: • Muscle aches • Joint pain • Backaches • Arthritis discomfort • Strains and sprains

Dosage & Administration

Directions Adults and children 12 years of age and older: Dispense a small amount using the dropper. Apply to affected area. Massage gently until absorbed. Use up to 3–4 times daily or as directed by a healthcare professional. Children under 12 years of age: consult a physician. Do not use otherwise than as directed.

Warnings

Warnings For external use only. Avoid contact with eyes and mucous membranes. Do not apply to damaged or irritated skin. Do not bandage tightly. Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately. Stop use and ask a doctor if: Condition worsens. Symptoms persist for more than 7 days or clear up and occur again within a few days. Excessive irritation occurs If pregnant or breast feeding, ask a health professional before use.

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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 North Star Nutritionals Soothanol X3 Pain Relieving Drops used for?
Uses For temporary relief of: • Muscle aches • Joint pain • Backaches • Arthritis discomfort • Strains and sprains

Who makes North Star Nutritionals Soothanol X3 Pain Relieving Drops?
NEWMARKET HEALTH PRODUCTS, LLC is the labeler of record for North Star Nutritionals Soothanol X3 Pain Relieving Drops. 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 North Star Nutritionals Soothanol X3 Pain Relieving Drops 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 North Star Nutritionals Soothanol X3 Pain Relieving Drops 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 North Star Nutritionals Soothanol X3 Pain Relieving Drops 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.