XtraCare Ice Cold Topical Analgesic Gel

XtraCare Ice Cold Topical Analgesic Gel is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by Rejoice International taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 57337-052, application M017, label effective 20231024. 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: xtracare ice, cold topical, analgesic gel. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

XtraCare® Ice Cold Topical Analgesic Gel Net Wt 8 oz (227 g)

Directions see important warnings under "When using this product" adults & children 2 years of age & older: apply to the affected area not more than 3 to 4 times daily. children under 2 years of age: consult a physician

Warnings For external use only. Avoid contact with eyes. Ask a doctor before use if you have cough associated with smoking excessive phlegm asthma emphysema persistent or chronic cough When using this product do not heat microwave add to hot water or any container where heating water may cause splattering and result in burns use in eyes or directly on mucous membranes take by mouth or place in nostrils apply to wounds or damaged skin bandage skin Consult a doctor and discontinue use if condition worsens, persists for more than 1 week or tends to recur.

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 XtraCare Ice Cold Topical Analgesic Gel used for?
XtraCare® Ice Cold Topical Analgesic Gel Net Wt 8 oz (227 g)

Who makes XtraCare Ice Cold Topical Analgesic Gel?
Rejoice International is the labeler of record for XtraCare Ice Cold Topical Analgesic Gel. 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 XtraCare Ice Cold Topical Analgesic Gel 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 XtraCare Ice Cold Topical Analgesic Gel 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 XtraCare Ice Cold Topical Analgesic Gel 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.