FDA Label for Biofreeze Overnight Roll-on
View Indications, Usage & Precautions
Biofreeze Overnight Roll-on 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.
Active
Mentol USP 4%
Purpose
Pain Relieving Gel
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with:
■simple backache
■arthritis
■strains
■bruises
■sprains
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 ■children 2 years to under 12 years of age: use only under adult supervision
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, or in conditions affecting children under 12 years of age
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 2 years of age and older:
rub a thin film over affected area not more than 3 to 4 times daily
■children under 2 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 Ingredients
Alcohol, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer Interpolymer, Colloidal Silicon Dioxide, Fragrance, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melissa Officinalis Leaf Extract, Purified Water, Tocopherol Acetate, Trolamine
Questions Or Comments
1-800-246-3733
Other
Dist. by: RB Health (US), Parsippany, NJ 07054-0224
Principal Display Panel - 74 Ml Bottle Label
CLINICALLY RECOMMENDED
NDC 59316-207-14
BIOFREEZE
COOL THE PAIN
ROLL-ON
MENTHOL- PAIN RELIEVING GEL
2.5 FL OZ (74mL)
SHAKE WELL BEFORE EACH USE
* Please review the disclaimer below.