Cold and Heat Lidocaine Patch Plus Menthol

Cold and Heat Lidocaine Patch Plus Menthol is an FDA-registered drug product whose active ingredient is LIDOCAINE, MENTHOL. It is labelled by Cardinal Health, 110 dba LEADER taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 70000-0558, application M017, label effective 20260514. It is one of 13 FDA drug label records sharing the active ingredient LIDOCAINE, 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 LIDOCAINE, MENTHOL are most often described in connection with: temporarily relieves, minor pain. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

USES Temporarily relieves minor pain

DIRECTIONS Adults and children 12 years of age and over: Adults and children 12 years of age and over: Use as directed Clean and dry affected area, free of lotions, ointments and creams Carefully remove backing from patch starting at a corner Apply sticky side of patch to affected area Do not use more than one patch in a 12 hour period Maximum 2 patches per day Discard patch after single use Children under 12 years of age: Consult a physician

WARNINGS For External use only. ■ More than one patch on your body at a time ■ On cut, irritated or swollen skin ■ On puncture wounds ■ For more than one week without consulting a doctor ■ If you are allergic to any active or inactive ingredients ■ If pouch is damaged or opened. WHEN USING: ■ Use only as directed ■ Read and follow all directions and warnings on this carton ■ Do not allow contact with the eyes ■ Do not use at the same time as other topical analgesics ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use ■ Do not microwave ■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. Stop use and consult a doctor if ■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or clear up and occur again within a few days ■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied. If pregnant or breast feeding ask a health professional before use If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

FDA lists 13 drug label records with LIDOCAINE, 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 Cold and Heat Lidocaine Patch Plus Menthol used for?
USES Temporarily relieves minor pain

Who makes Cold and Heat Lidocaine Patch Plus Menthol?
Cardinal Health, 110 dba LEADER is the labeler of record for Cold and Heat Lidocaine Patch Plus Menthol. 13 FDA label records share the active ingredient LIDOCAINE, 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 Cold and Heat Lidocaine Patch Plus Menthol 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 Cold and Heat Lidocaine Patch Plus Menthol 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, MENTHOL?
Yes. 13 FDA drug label records list LIDOCAINE, 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 Cold and Heat Lidocaine Patch Plus Menthol 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.