NUMOTIZINE

NUMOTIZINE is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by Hobart Laboratories, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 10546-100, application M017, label effective 20231020. 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.

Across FDA labelling, products containing MENTHOL are most often described in connection with: topical analgesic, provides temporary, relief muscle, pain soreness, strains sprains, tendon injuries. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses For use as a topical analgesic Provides temporary relief of muscle pain, soreness and stiffness Temporary pain relief on strains, sprains, ligament and tendon injuries Arthritis

Directions Stir in any liquid at top of jar. Keep sealed when not in use. Spread 1/8" to 1/4" of ointment to the skin. Cover the ointment with a cloth or bandage to protect clothing. Remove with warm water before totally dry (usually 8 to 12 hours). Application may be repeated every 12 hours as needed.

Warnings: For external use only. Use only as directed. Avoid contact with eyes and mucous memebranes. Do not apply to irritated or broken skin or to large areas of the body.

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.

What is NUMOTIZINE used for?
Uses For use as a topical analgesic Provides temporary relief of muscle pain, soreness and stiffness Temporary pain relief on strains, sprains, ligament and tendon injuries Arthritis

Who makes NUMOTIZINE?
Hobart Laboratories, Inc. is the labeler of record for NUMOTIZINE. 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 NUMOTIZINE 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 NUMOTIZINE 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 NUMOTIZINE 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.