Lidocaine 4% Cream

Lidocaine 4% Cream is an FDA-registered drug product whose active ingredient is LIDOCAINE. It is labelled by Medcore LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 82461-419, application M017, label effective 20260507. It is one of 152 FDA drug label records sharing the active ingredient LIDOCAINE. 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 are most often described in connection with: temporarily relieves, itching due, minor cuts, burns insect, skin irritations. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporarily relieves pain and itching due to: minor cuts sunburn minor scrapes minor burns insect bites minor skin irritations

DIRECTIONS Adults and children 2 years and older: apply externally to the affected area up to 3 to 4 times a day Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day. children under 2 years ask a doctor

Warnings For external use only. When using this product do not use in or near the eyes do not use in large quantities, particularly over raw surfaces or blistered areas do not use If pregenant or breastfeeding.

FDA lists 152 drug label records with LIDOCAINE 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% Cream used for?
Uses Temporarily relieves pain and itching due to: minor cuts sunburn minor scrapes minor burns insect bites minor skin irritations

Who makes Lidocaine 4% Cream?
Medcore LLC is the labeler of record for Lidocaine 4% Cream. 152 FDA label records share the active ingredient LIDOCAINE, 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% Cream 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% Cream 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?
Yes. 152 FDA drug label records list LIDOCAINE 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% Cream 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.