FDA Label for Biofreeze Day And Overnight
View Indications, Usage & Precautions
Biofreeze Day And Overnight Product Label
The following document was submitted to the FDA by the labeler of this product Rb Health (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Menthol 5%
Pain Relieving Patch
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.