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  5. Label Information: Biofreeze Flexible Relief Strip

FDA Label for Biofreeze Flexible Relief Strip

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS:
    3. PURPOSE
    4. USES:
    5. WARNINGS:
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE:
    7. WHEN USING THIS PRODUCT:
    8. DO NOT USE
    9. STOP USE AND ASK A DOCTOR IF:
    10. IF PREGNANT OR BREASTFEEDING:
    11. KEEP OUT OF REACH OF CHILDREN:
    12. DIRECTIONS:
    13. INACTIVE INGREDIENTS:
    14. QUESTIONS OR COMMENTS:
    15. PACKAGE LABELING:(59316-004-01)
    16. PACKAGE LABELING:(59316-004-04)

Biofreeze Flexible Relief Strip 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 Ingredients:



Menthol 5.6%


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 
  • 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
  • Do not overwrap or wrap strips over themselves
  • Wash hands after use with cool water
  • Do not bandage or use with heating pad or device
  • Store in a cool dry place away from direct sunlight

Stop Use And Ask A Doctor If:



You experience pain, swelling or blistering; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days


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, partially peel back protective film and apply exposed strip to site of pain. Carefully remove remaining film while pressing the strip to the skin and leave in place for up to 8 hours. Do not stretch the strip during application as it should be comfortable and not tight. Use on affected areas not more than 4 times daily. For best adhesion: area should be clean, dry, and smooth 
  • Children under 12 years of age: Consult physician

Inactive Ingredients:



Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Benzalkonium Chloride, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Isopropyl Myristate, Kaolin, L-Tartaric Acid, Lauralkonium Chloride, Mineral Oil, Nonoxynol-10, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium Dioxide, Water


Questions Or Comments:



1-800-246-3733


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