FDA Label for Biofreeze

View Indications, Usage & Precautions

Biofreeze 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 Ingredients



Menthol USP 10.5%


Purpose



Cooling Pain Relief


Uses:



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


Warnings:



For external use only.

Flammable: Keep away from excessive heat or open flame.

Contents Under Pressure. Do Not Puncture Or Incinerate Do Not Store At Temperature Above 120°F


Ask A Doctor Before Using If You Have:



 Sensitive skin


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.


Directions:



Adults andchildren 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


Inactive Ingredients:



Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone (MSM), Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water


Questions Or Comments?



1-800-246-3733


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