PlayMakar Roll On Cool Pain Relief

PlayMakar Roll On Cool Pain Relief is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by PlayMakar Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 72909-015, application M017, label effective 20231105. 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: 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 dail 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 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 PlayMakar Roll On Cool Pain Relief 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 PlayMakar Roll On Cool Pain Relief?
PlayMakar Inc. is the labeler of record for PlayMakar Roll On Cool 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 PlayMakar Roll On Cool 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 PlayMakar Roll On Cool 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 PlayMakar Roll On Cool 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.