Drugplain

Biofreeze Overnight Relief .3 g/6g

Menthol, Unspecified Form · PATCH · Reckitt Benckiser LLC

No Recall History
Plain English

Biofreeze Overnight Relief is a patch containing menthol, unspecified form at .3 g/6g, taken topical. Manufactured by Reckitt Benckiser LLC.

Key Facts

Brand Name
Biofreeze Overnight Relief
Generic Name
Menthol, Unspecified Form
NDC Code (Product)
59316-005
Manufacturer
Reckitt Benckiser LLC
Strength
.3 g/6g
Dosage Form
PATCH
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
02/01/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

application site pain1 reports
hair disorder1 reports
hypoaesthesia1 reports
limb injury1 reports
nerve injury1 reports
pain in extremity1 reports
paraesthesia1 reports
skin burning sensation1 reports
stroke in evolution1 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 symptons 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 Overnight Relief used for?

Biofreeze Overnight Relief contains Menthol, Unspecified Form. It is a patch taken topical. Consult your doctor for specific uses.

Is Biofreeze Overnight Relief a controlled substance?

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

What is the generic name for Biofreeze Overnight Relief?

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

What is the NDC code for Biofreeze Overnight Relief .3 g/6g?

The NDC (National Drug Code) for Biofreeze Overnight Relief .3 g/6g is 59316-005, listed by Reckitt Benckiser LLC.