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  5. Label Information: Biofreeze

FDA Label for Biofreeze

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. PURPOSE
    3. USES:
    4. WARNINGS:
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE:
    6. WHEN USING THIS PRODUCT:
    7. STOP USE AND ASK A DOCTOR IF:
    8. IF PREGNANT OR BREASTFEEDING:
    9. KEEP OUT OF REACH OF CHILDREN:
    10. DIRECTIONS:
    11. INACTIVE INGREDIENTS:
    12. QUESTIONS OR COMMENTS:
    13. 69316-889-04
    14. 59316-993-32
    15. PACKAGE LABELING: 59316-993-33

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 5%


Purpose



Cooling Pain Relief


Uses:



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


Warnings:



For external use only


Ask A Doctor Before Use If You Have:



Sensitive skin


When Using This Product:



• Use only as directed • Do not bandage tightly or use with heating pad or device • 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 • Store in a cool dry place away from direct sunlight


Stop Use And Ask A Doctor If:



Burning discomfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and recur


If Pregnant Or Breastfeeding:



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 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 areas not more than 4 times daily. Wash hands with cool water after use
• Children under 12 years of age: Consult physician


Inactive Ingredients:



Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Diazolidinyl Urea, Dihydroxyaluminum Aminoacetate, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water


Questions Or Comments:



1-800-246-3733


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