Otc - Active Ingredient
Menthol 5%
Pain Relieving Patch
Biofreeze Patch
FDA Label NDC 59316-992
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Biofreeze (NDC 59316-992). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, uses, warnings, directions, other information, inactive ingredient, questions, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Temporarily relieves minor aches and pains of muscles and
joints associated with:
■ simple backache
■ arthritis
■ strains
■ bruises
■ sprains
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
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
Other Information
■ store at 20-25°C (68-77°F)
■ store in a cool dry place away from direct sunlight
Inactive Ingredient
Large Patch:
1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower
Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract,
Carboxymethylcellulose Sodium, DihydroxyaluminumAminoacetate, Ethylhexylglycerin,
Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Petrolatum,
Phenoxyethanol, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol,
PurifiedWater, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide
Overnight Relief Patch:
Benzalkonium Chloride, Carboxymethylcellulose Sodium, Dihydroxyaluminum
Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Lauralkonium Chloride,
Lavender Oil, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80,
Povidone, Propylene Glycol, Purified Water, Sodium Polyacrylate,
Tartaric Acid, Titanium Dioxide
Questions
1-866-682-4639
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Purpose
Menthol 5%
Purpose:
Pain Relieving Patch
* Please review the disclaimer below.
