U ICE COLD

U ICE COLD is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by UNIVERSAL DISTRIBUTION CENTER LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 52000-045, application M017, label effective 20230901. 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: affected area, directions clean, applying products, children years, older apply, times daily. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Directions clean affected area before applying products adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily

Uses: for the temporary relief of minor aches and pains in muscles and joints associated with: simple backache, strains, sprains, sports injuries, arthritis, bruises

Warnings: External Use Only For external use only.

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 U ICE COLD used for?
Directions clean affected area before applying products adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily

Who makes U ICE COLD?
UNIVERSAL DISTRIBUTION CENTER LLC is the labeler of record for U ICE COLD. 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 U ICE COLD 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 U ICE COLD 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 U ICE COLD 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.