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  5. Label Information: Biofreeze Precision Relief Pen

FDA Label for Biofreeze Precision Relief Pen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. PURPOSE
    3. USES:
    4. WARNINGS:
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE:
    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:59316-830-37
    15. PACKAGE LABELING:59316-830-38

Biofreeze Precision Relief Pen 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 • sprains


Warnings:



For external use only


Ask A Doctor Before Use If You Have:



Sensitive skin

Flammable: Keep away from excessive heat or open flame


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 • 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: Press pen straight down onto affected area and hold until tip is fully soaked with liquid. Using light pressure, dab onto affected area and let dry. Repeat use not more than 4 times daily. Massage not necessary
• Children under 12 years of age: Consult physician


Inactive Ingredients:



Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone, Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water


Questions Or Comments:



1-800-246-3733


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