Lidocaine 4% Patch

Lidocaine 4% Patch is an FDA-registered drug product whose active ingredient is LIDOCAINE 4%. It is labelled by Blue Heron Pharmaceuticals LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85622-521, application 505G(a)(3), label effective 20260811. 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 the temporary relief of pain

Directions Adult and children 12 years of age and over: Clean and dry affected area Peel patch off plastic liner and place patch on affected area for no more than 12 hours Wash hands after applying patch Under age 12, consult a physician before use For easier removal of the patch, apply rubbing alcohol or baby oil to adhesive edge while gently peeling Children under 12 years of age: Consult a doctor

Warnings For external use only

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 4% Patch used for?
Uses For the temporary relief of pain

Who makes Lidocaine 4% Patch?
Blue Heron Pharmaceuticals LLC is the labeler of record for Lidocaine 4% Patch. 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 4% Patch 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 Lidocaine 4% Patch 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 4% Patch 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.