Drugplain

Biofreeze Precision Relief Pen 105 mg/mL

MENTHOL · LIQUID · Reckitt Benckiser LLC

No Recall History
Plain English

Biofreeze Precision Relief Pen is a liquid containing menthol at 105 mg/mL, taken topical. Manufactured by Reckitt Benckiser LLC.

Key Facts

Brand Name
Biofreeze Precision Relief Pen
Generic Name
MENTHOL
NDC Code (Product)
59316-830
Manufacturer
Reckitt Benckiser LLC
Strength
105 mg/mL
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
12/31/2020

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: shake well before use. Press pen straight down onto affected area and hold until tip is fully soaked with liquid. Using light pressure, dab onto skin and let dry. Apply to affected area not more than 3 to 4 times daily; massage not necessary children under 12 years of age: consult a physician wash hands after use with cool water

Warnings

Warnings For external use only. Flammable: Keep away from excessive heat or open flame 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 Precision Relief Pen used for?

Biofreeze Precision Relief Pen contains MENTHOL. It is a liquid taken topical. Consult your doctor for specific uses.

Is Biofreeze Precision Relief Pen a controlled substance?

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

What is the generic name for Biofreeze Precision Relief Pen?

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

What is the NDC code for Biofreeze Precision Relief Pen 105 mg/mL?

The NDC (National Drug Code) for Biofreeze Precision Relief Pen 105 mg/mL is 59316-830, listed by Reckitt Benckiser LLC.