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  5. Label Information: Biofreeze Foam

FDA Label for Biofreeze Foam

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. PURPOSE
    3. USES:
    4. WARNINGS:
    5. ASK A DOCTOR BEFORE USE
    6. WHEN USING THIS PRODUCT:
    7. DO NOT USE
    8. STOP USE AND ASK A DOCTOR IF:
    9. IF PREGNANT OR BREASTFEEDING:
    10. KEEP OUT OF REACH OF CHILDREN:
    11. DIRECTIONS:
    12. INACTIVE INGREDIENTS:
    13. QUESTIONS OR COMMENTS:
    14. PACKAGE LABELING:

Biofreeze Foam 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 7%


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

Flammable: Keep away from excessive heat or open flame


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 at room temperature 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 occur 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: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
• Children under 12 years of age: Consult physician


Inactive Ingredients:



Alcohol Denat., Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Bis-PEG-10 Dimethicone, Boswellia Carterii Resin Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Hydroxyethyl Cetyldimonium Phosphate, Ilex Paraguariensis Leaf Extract, Isopropyl Palmitate, Melissa Officinalis Leaf Extract, PEG-12 Dimethicone,Pentylene Glycol, PPG-24-Glycereth-24, Water


Questions Or Comments:



1-800-246-3733


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