Biofreeze Ultraflex Plus

Biofreeze Ultraflex Plus is an FDA-registered drug product whose active ingredient is LIDOCAINE, MENTHOL. It is labelled by Reckitt Benckiser LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 59316-898, application M017, label effective 20260602. It is one of 13 FDA drug label records sharing the active ingredient LIDOCAINE, MENTHOL. 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, MENTHOL are most often described in connection with: temporary relief. 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

Directions 􀂄 adults and children 12 years of age and older: Clean and dry affected area, cut open pouch and remove patch from protective film by first peeling back center film. Apply exposed patch to affected area. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. (see images on carton) 􀂄 use 1 patch at a time and not more than 3 to 4 times daily 􀂄 children under 12 years of age: consult a physician 􀂄 wash hands after use with cool water

Warnings For external use only. Do not use 􀂄 more than 1 patch on your body at a time or with other topical anesthetics at the same time 􀂄 on wounds, damaged skin, rashes, or swollen skin 􀂄 with a heating pad or apply local heat to the area of use 􀂄 in large quantities, particularly over raw surfaces or blistered areas When using this product 􀂄 use only as directed 􀂄 do not bandage tightly 􀂄 avoid contact with the eyes or on mucous membranes 􀂄 dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. Stop use and ask a doctor if 􀂄 the condition for which this preparation is used persists or if a rash, redness or irritation develops 􀂄 condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within few days 􀂄 you experience pain, swelling or blistering of the skin If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children and pets . If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 13 drug label records with LIDOCAINE, MENTHOL 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 Biofreeze Ultraflex Plus used for?
Uses For the temporary relief of pain

Who makes Biofreeze Ultraflex Plus?
Reckitt Benckiser LLC is the labeler of record for Biofreeze Ultraflex Plus. 13 FDA label records share the active ingredient LIDOCAINE, MENTHOL, 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 Biofreeze Ultraflex Plus 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 Biofreeze Ultraflex Plus 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, MENTHOL?
Yes. 13 FDA drug label records list LIDOCAINE, MENTHOL 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 Biofreeze Ultraflex Plus 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.