Lidocaine HCl

Lidocaine HCl is an FDA-registered drug product whose active ingredient is LIDOCAINE HCL. It is labelled by Topco Associates LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 76162-034, application M017, label effective 20260805. It is one of 11 FDA drug label records sharing the active ingredient LIDOCAINE HCL. 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 HCL are most often described in connection with: temporary relief, itching associated, minor burns, cuts scrapes, insect bites, skin irritations. 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 and itching associated with minor burns sunburn minor cuts scrapes insect bites minor skin irritations

Directions adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor

Warnings For external use only

Adverse Reaction DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 © TOPCO QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com Visit here for more information: http://topbrands.com/6csegg QUALITY GUARANTEED

FDA lists 11 drug label records with LIDOCAINE HCL 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 HCl used for?
Uses for the temporary relief of pain and itching associated with minor burns sunburn minor cuts scrapes insect bites minor skin irritations

Who makes Lidocaine HCl?
Topco Associates LLC is the labeler of record for Lidocaine HCl. 11 FDA label records share the active ingredient LIDOCAINE HCL, 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 HCl 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 HCl 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 HCL?
Yes. 11 FDA drug label records list LIDOCAINE HCL 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 HCl 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.