Lidocaine Patch 4%

Lidocaine Patch 4% is an FDA-registered drug product whose active ingredient is LIDOCAINE 4%. It is labelled by Global America Group LLC taken by transdermal and marketed as a human otc drug product. Identifiers on file: NDC 87843-211, application M017, label effective 20260826. It is one of 31 FDA drug label records sharing the active ingredient LIDOCAINE 4%. 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 4% 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 temporary relief of pain

Directions Adult and children 12 years of age and over : clean and dry affected area apply 1 patch at a time to affected area,not more than 3 to 4 times daily remove patch from the skin after at most 8-hour application Children under 12 years of age : consult a doctor

Warnings (​For external use only) Do not use more than 1 patch at a time on wounds or damaged skin with a heating pad if you are allergic to any ingredients of this product When using this product use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly Stop use and ask a doctor if localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering condition worsen symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breast-feeding,​ ask a health professional before use. Keep out of reach of children.​ If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 31 drug label records with LIDOCAINE 4% 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 Lidocaine Patch 4% used for?
Uses For temporary relief of pain

Who makes Lidocaine Patch 4%?
Global America Group LLC is the labeler of record for Lidocaine Patch 4%. 31 FDA label records share the active ingredient LIDOCAINE 4%, 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 Lidocaine Patch 4% come in?
administered by transdermal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Lidocaine Patch 4% 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 4%?
Yes. 31 FDA drug label records list LIDOCAINE 4% 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 Lidocaine Patch 4% 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.