Lidocaine Cream

Lidocaine Cream is an FDA-registered drug product whose active ingredient is LIDOCAINE. It is labelled by InvaDerm Corporation taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 71457-525, application M015, label effective 20260901. 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, itchingdue anorectal. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporarily relieves pain and itchingdue to anorectal disorders.

Directions When practical, clean affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. Children under 12 years of age: Ask a doctor.

Warnings When using this product avoid contact with eyes do not exceed recommended dosage unless directed by a doctor Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs redness, irritation, swelling, pain or other symptoms begin or increase symptoms clear up and return within a few days

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.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Lidocaine Cream used for?
Uses Temporarily relieves pain and itchingdue to anorectal disorders.

Who makes Lidocaine Cream?
InvaDerm Corporation is the labeler of record for Lidocaine 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 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 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 Cream been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.