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  5. Label Information: Biofreeze Pain Relief

FDA Label for Biofreeze Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREIDENTS
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE:
    7. WHEN USING THIS PRODUCT:
    8. STOP USE AND ASK A DOCTOR IF:
    9. IF PREGNANT OR BREAT-FEEDING:
    10. KEEP OUT OF REACH OF CHILDREN:
    11. DIRECTIONS
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS
    14. PACKAGE LABELING

Biofreeze Pain 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.

Drug Facts




Active Ingreidents



Menthol 10%


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.


Ask A Doctor Before Use If You Have:



Sensitive skin


When Using This Product:



  •  Avoid contact with 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 Breat-Feeding:



Ask a health professional before use


Keep Out Of Reach Of Children:



If accidentally ingested, get medical help or contact a Poison Contropl Center immediately


Directions



  • Adults and children 12 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary.
  • Childern under 12 years of age:  Consult physician

Inactive Ingredients



Caprylic/Capric Triglyceride, Cetearyl Alcohol, Diazolidinyl Urea, Dimethicone, Glycerin, Glyceryl Stearate, Gluconolactone, Ilex Paraguariensis Leaf Extract, Iodopropynyl butylcarbamate, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) seed Oil, Water


Questions Or Comments



1-800-246-3733


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