Unburn

Unburn is an FDA-registered drug product whose active ingredient is LIDOCAINE HYDROCHLORIDE. It is labelled by Water-Jel Technologies taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 59898-500, application part348, label effective 20171201. It is one of 110 FDA drug label records sharing the active ingredient LIDOCAINE HYDROCHLORIDE. 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 HYDROCHLORIDE are most often described in connection with: temporary relief, pain associated, sunburn minor, skin irritations, insect bites. 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 associated with: sunburn minor burns minor skin irritations insect bites

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: consult a doctor

Warnings For external use only Do not use in large quantities, particularly over raw surfaces or blistered areas When using this product avoid contact with eyes Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days condition clears up and occurs again within a few days Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 110 drug label records with LIDOCAINE HYDROCHLORIDE 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.

1 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 Unburn used for?
Uses for the temporary relief of pain associated with: sunburn minor burns minor skin irritations insect bites

Who makes Unburn?
Water-Jel Technologies is the labeler of record for Unburn. 110 FDA label records share the active ingredient LIDOCAINE HYDROCHLORIDE, 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 Unburn 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 Unburn 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 HYDROCHLORIDE?
Yes. 110 FDA drug label records list LIDOCAINE HYDROCHLORIDE 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 Unburn been recalled?
1 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.