Drugplain

Biofreeze Menthol

Menthol, Unspecified form · KIT · Reckitt Benckiser LLC

No Recall History
Plain English

Biofreeze Menthol is a kit containing menthol, unspecified form. Manufactured by Reckitt Benckiser LLC.

Key Facts

Brand Name
Biofreeze Menthol
Generic Name
Menthol, Unspecified form
NDC Code (Product)
59316-887
Manufacturer
Reckitt Benckiser LLC
Dosage Form
KIT
Marketing Status
Application #
M017
Marketing Start
03/10/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue57 reports
pain53 reports
diarrhoea46 reports
fall43 reports
drug ineffective42 reports
arthralgia40 reports
headache37 reports
pain in extremity34 reports
back pain33 reports
asthenia29 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage & Administration

Directions adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. Use on affected area 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

Warnings For external use only. When using this product use only as directed avoid contact with the eyes or on mucous membranes do not apply to wounds or damaged skin do not apply to irritated skin or if excessive irritation develops do not bandage tightly or use with heating pad or device Stop use and ask a doctor if 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Biofreeze Menthol used for?

Biofreeze Menthol contains Menthol, Unspecified form. It is a kit taken as directed. Consult your doctor for specific uses.

Is Biofreeze Menthol a controlled substance?

Biofreeze Menthol is not classified as a controlled substance by the DEA.

What is the generic name for Biofreeze Menthol?

The generic name for Biofreeze Menthol is Menthol, Unspecified form. There are 12 other brand versions of Menthol, Unspecified form.

What is the NDC code for Biofreeze Menthol ?

The NDC (National Drug Code) for Biofreeze Menthol is 59316-887, listed by Reckitt Benckiser LLC.