FDA Label for Biofreeze Overnight Relief
View Indications, Usage & Precautions
Biofreeze Overnight Relief 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.
Other
Drug Facts
Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
Made in China
Active Ingredient
Menthol 5%
Purpose
Topical analgesic
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 symptons 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
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° (68-77°F)
- store in a cool dry place away from direct sunlight
Inactive Ingredients
Benzalkonium Chloride, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Lauralkonium Chloride, Lavandula Angustifolia (Lavender) Oil, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
Questions Or Comments?
1-800-246-3733
Principal Display Panel - 4 Patch Pouch Carton
CLINICALLY
RECOMMENDED
NDC 59316-005-04
BIOFREEZE®
COOL THE PAIN
OVERNIGHT
RELIEF
PATCHES
MENTHOL-TOPICAL
ANALGESIC
Overnight pain relief patch
Scented with lavender
essential oil
Designed to stay on
through the night
Optimized for comfort
and flexibility
4 PATCHES
5.125 in x 2.6 in
(13 cm x 6.6 cm) each
* Please review the disclaimer below.