Menthozen Hydrogel

Menthozen Hydrogel is an FDA-registered drug product whose active ingredient is MENTHOL, CAPSAICIN. It is labelled by Proficient Rx LP taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 71205-334, application M017, label effective 20231201. It is one of 3 FDA drug label records sharing the active ingredient MENTHOL, CAPSAICIN. 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.

Across FDA labelling, products containing MENTHOL, CAPSAICIN are most often described in connection with: temporary relief, minor aches, joints associated, simple backache, arthritis strains. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

DIRECTIONS: Adults and children 12-years and over: Apply to affected area; change patch 1-2 times dily. Children under 12, consult a physician before use. How to Apply : Remove patch from backing and apply directly to area of pain. Do not apply to affected area more than three times daily. Use only one patch at a time. Wash hands with soap and water immediately after application. Reseal pouch containg unused patches.

WARNINGS: For external use only. Use only as directed. • Avoid contact with eyes and mucous membranes. • Do not apply to open wounds or damaged skin. Do not use • in combination with any external heat source. • Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment. Keep out of reach of children. • Do not use if allergic to Menthol. Stop use and consult physician • if symptoms worsen or persist for more than 7 days. • Stop use if itching or excessive skin irritation occurs. If pregnant or breast feeding, • contact physician prior to use

FDA lists 3 drug label records with MENTHOL, CAPSAICIN 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.

What is Menthozen Hydrogel used for?
USES: For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Who makes Menthozen Hydrogel?
Proficient Rx LP is the labeler of record for Menthozen Hydrogel. 3 FDA label records share the active ingredient MENTHOL, CAPSAICIN, 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 Menthozen Hydrogel 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 Menthozen Hydrogel 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, CAPSAICIN?
Yes. 3 FDA drug label records list MENTHOL, CAPSAICIN 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 Menthozen Hydrogel 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.