Biofreeze

Biofreeze is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by Reckitt Benckiser LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 59316-833, application M017, label effective 20260513. It is one of 193 FDA drug label records sharing the active ingredient 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 MENTHOL are most often described in connection with: temporary relief, minor aches, pains sore, joints associated, arthritis backache. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis backache strains and sprains

Directions: Adults and children 12 years of age and older: Spray on to the affected areas not more than 4 times daily; massage not necessary Children under 12 years of age: Consult physician

Warnings For external use only. Flammable: Keep away from excessive heat or open flame. Contents Under Pressure. Do Not Punture Or Incinerate Do Not Store At Temperature Above 120°F Ask a Doctor Before using If You have: ■ you experience pain, swelling or blistering of the skin ■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ■ arthritic pain persists for more than 10 days, or redness is present When Using This Product Avoid contact with the eyes or mucous membranes; Do not apply to wounds or damaged skin; Do not use with other ointments, creams, sprays or liniments; Do not apply to irritated skin or if excessive irritation develops; Do not bandage; Wash hands after use with cool water; Do not use with heating pad or device; Store in a cool dry place Stop Use And Ask A Doctor If: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur If pregnant or breast-feeding: Ask a health professional before use Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately

FDA lists 193 drug label records with 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 used for?
Uses Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis backache strains and sprains

Who makes Biofreeze?
Reckitt Benckiser LLC is the labeler of record for Biofreeze. 193 FDA label records share the active ingredient 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 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 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 MENTHOL?
Yes. 193 FDA drug label records list 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 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.