Drugplain

BIOFREEZE 40 mg/mL

MENTHOL · GEL · Reckitt Benckiser LLC

No Recall History
Plain English

BIOFREEZE is a gel containing menthol at 40 mg/mL, taken topical. Manufactured by Reckitt Benckiser LLC.

Key Facts

Brand Name
BIOFREEZE
Generic Name
MENTHOL
NDC Code (Product)
59316-102
Manufacturer
Reckitt Benckiser LLC
Strength
40 mg/mL
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
01/03/2012

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

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

Frequently Asked Questions

What is BIOFREEZE used for?

BIOFREEZE contains MENTHOL. It is a gel taken topical. Consult your doctor for specific uses.

Is BIOFREEZE a controlled substance?

BIOFREEZE is not classified as a controlled substance by the DEA.

What is the generic name for BIOFREEZE?

The generic name for BIOFREEZE is MENTHOL. There are 12 other brand versions of MENTHOL.

What is the NDC code for BIOFREEZE 40 mg/mL?

The NDC (National Drug Code) for BIOFREEZE 40 mg/mL is 59316-102, listed by Reckitt Benckiser LLC.