EXOTEN-C

EXOTEN-C is an FDA-registered drug product whose active ingredient is METHYL SALICYLATE, MENTHOL, CAPSAICIN. It is labelled by Asclemed USA, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 76420-947, application M017, label effective 20231016. It is one of 4 FDA drug label records sharing the active ingredient METHYL SALICYLATE, 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 METHYL SALICYLATE, MENTHOL, CAPSAICIN are most often described in connection with: temporary relief, minor aches, joints associated, arthritis simple, backache sprains. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Directions Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age consult a physician.

Warnings For external use only. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician. Keep out of reach of children. If swallowed, consult physician. Do not apply to wounds or damaged skin. Do not bandage tightly. If pregnant or breast feeding, contact physician prior to use.

FDA lists 4 drug label records with METHYL SALICYLATE, 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 EXOTEN-C used for?
Indications For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Who makes EXOTEN-C?
Asclemed USA, Inc. is the labeler of record for EXOTEN-C. 4 FDA label records share the active ingredient METHYL SALICYLATE, 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 EXOTEN-C 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 EXOTEN-C 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 METHYL SALICYLATE, MENTHOL, CAPSAICIN?
Yes. 4 FDA drug label records list METHYL SALICYLATE, 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 EXOTEN-C 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.