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  5. Label Information: Biofreeze Professional

FDA Label for Biofreeze Professional

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL

Biofreeze Professional 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.

Other



Drug Facts

Dist. by: RB Health (US), Parsippany, NJ 07054-0224


Active Ingredient



Menthol 10.5%


Purpose



Pain Relieving Spray


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

Contents under pressure. Do not puncture or incinerate.

Do not store at temperature above 120°F.


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

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

Otc - Pregnancy Or Breast Feeding



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 12 years of age and older: spray on to affected area not more than 3 to 4 times daily; massage not necessary
  • children under 12 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

Questions Or Comments?



1-800-246-3733


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