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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. FLAMMABLE:
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE:
    7. WHEN USING THIS PRODUCT:
    8. STOP USE AND ASK A DOCTOR IF:
    9. IF PREGNANT OR BREASTFEEDING:
    10. KEEP OUT OF REACH OF CHILDREN:
    11. DIRECTIONS
    12. OTHER INFORMATION:
    13. INACTIVE INGREDIENTS:
    14. QUESTIONS OR COMMENTS?
    15. BIOFREEZE - MENTHOL SPRAY (59316-104-10)
    16. BIOFREEZE - MENTHOL SPRAY (59316-104-30)

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 10%


Purpose



Cooling Pain Reliever


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:



 -Avoid contact with the eyes or mucous membranes - Do not apply to wounds or damages 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


Stop Use And Ask A Doctor If:



Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur



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 / Children 12 years and older: Apply on to affected area up to 4 times daily

Children under 12 years of age: Consult a physician


Other Information:



Store in a cool dry place with lid closed tightly


Inactive Ingredients:



Arnica Montana, Calendula,Chamomile, Dimethyl Sulfone (MSM), Echinacea, Ethanol,  Lex Paraguarenis, Isopropyl Myristate, Juniper Berry, Purified Water USP, White Tea


Questions Or Comments?



1-800-246-3733


* Please review the disclaimer below.