Burn Cream

Burn Cream is an FDA-registered drug product whose active ingredient is BENZALKONIUM CHLORIDE, LIDOCAINE HCI. It is labelled by Trifecta Pharmaceuticals USA LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 69396-105, application M003, label effective 20260909. It is one of 4 FDA drug label records sharing the active ingredient BENZALKONIUM CHLORIDE, LIDOCAINE HCI. 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 BENZALKONIUM CHLORIDE, LIDOCAINE HCI are most often described in connection with: temporary relief, pain associated, minor cuts, burns helps, protect against, harmful bacteria. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporary Relief of pain associated with minor cuts, scrapes and burns. Helps protect against harmful bacteria.

Directions Clean the affected area Apply a small amount not more than 3 times daily May be covered with a sterile bandage

Warnings For external Use Only Do not use in eyes in large quantities over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns for more than one week unless directed by a doctor

FDA lists 4 drug label records with BENZALKONIUM CHLORIDE, LIDOCAINE HCI 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 Burn Cream used for?
Uses Temporary Relief of pain associated with minor cuts, scrapes and burns. Helps protect against harmful bacteria.

Who makes Burn Cream?
Trifecta Pharmaceuticals USA LLC is the labeler of record for Burn Cream. 4 FDA label records share the active ingredient BENZALKONIUM CHLORIDE, LIDOCAINE HCI, 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 Burn 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 Burn 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 BENZALKONIUM CHLORIDE, LIDOCAINE HCI?
Yes. 4 FDA drug label records list BENZALKONIUM CHLORIDE, LIDOCAINE HCI 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 Burn 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.