1. Home
  2. Labeler Index
  3. Rb Health (us) Llc
  4. 59316-833
  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. FLAMMABLE:
    6. ASK A DOCTOR BEFORE USING IF YOU HAVE:
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF:
    9. IF PREGNANT OR BREAST-FEEDING:
    10. KEEP OUT OF REACH OF CHILDREN:
    11. DIRECTIONS:
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS:
    14. PACKAGE LABELING:

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 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.


Ask A Doctor Before Using If You Have:



■ 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


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 and children 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


Questions Or Comments:



1-800-246-3733


* Please review the disclaimer below.