Drugplain

Biofreeze Flexible Relief Strip 56 mg/g

MENTHOL · PATCH · Reckitt Benckiser LLC

No Recall History
Plain English

Biofreeze Flexible Relief Strip is a patch containing menthol at 56 mg/g, taken topical. Manufactured by Reckitt Benckiser LLC.

Key Facts

Brand Name
Biofreeze Flexible Relief Strip
Generic Name
MENTHOL
NDC Code (Product)
59316-004
Manufacturer
Reckitt Benckiser LLC
Strength
56 mg/g
Dosage Form
PATCH
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
03/31/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use92 reports
drug ineffective82 reports
dyspnoea82 reports
fatigue81 reports
pain75 reports
pruritus72 reports
dizziness65 reports
cough64 reports
headache63 reports
drug hypersensitivity58 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. do not stretch the patch during application as it should be comfortable and not tight do not overwrap or wrap patches over themselves for best adhesion: area should be clean, dry, and smooth 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 Flexible Relief Strip used for?

Biofreeze Flexible Relief Strip contains MENTHOL. It is a patch taken topical. Consult your doctor for specific uses.

Is Biofreeze Flexible Relief Strip a controlled substance?

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

What is the generic name for Biofreeze Flexible Relief Strip?

The generic name for Biofreeze Flexible Relief Strip is MENTHOL. There are 12 other brand versions of MENTHOL.

What is the NDC code for Biofreeze Flexible Relief Strip 56 mg/g?

The NDC (National Drug Code) for Biofreeze Flexible Relief Strip 56 mg/g is 59316-004, listed by Reckitt Benckiser LLC.