Zylotrol

Zylotrol is an FDA-registered drug product whose active ingredient is LIDOCAINE HCL 4%, MENTHOL 1%. It is labelled by Whitestone Products LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 81902-201, application M017, label effective 20231016. It is one of 2 FDA drug label records sharing the active ingredient LIDOCAINE HCL 4%, MENTHOL 1%. 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 LIDOCAINE HCL 4%, MENTHOL 1% are most often described in connection with: temporary relief. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses For the temporary relief of pain.

Directions Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times a daily. Children under 2 years of age: consult a doctor.

Warnings For external use only not intended for ingestion.

FDA lists 2 drug label records with LIDOCAINE HCL 4%, MENTHOL 1% 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 Zylotrol used for?
Uses For the temporary relief of pain.

Who makes Zylotrol?
Whitestone Products LLC is the labeler of record for Zylotrol. 2 FDA label records share the active ingredient LIDOCAINE HCL 4%, MENTHOL 1%, 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 Zylotrol 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 Zylotrol 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 LIDOCAINE HCL 4%, MENTHOL 1%?
Yes. 2 FDA drug label records list LIDOCAINE HCL 4%, MENTHOL 1% 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 Zylotrol 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.