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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. ASK A DOCTOR BEFORE USE IF YOU HAVE:
    6. WHEN USING THIS PRODUCT:
    7. STOP USE AND ASK A DOCTOR IF:
    8. IF PREGNANT OR BREASTFEEDING:
    9. KEEP OUT OF REACH OF CHILDREN:
    10. DIRECTIONS:
    11. INACTIVE INGREDIENTS:
    12. QUESTIONS OR COMMENTS:
    13. 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 USP 10%


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


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 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 four times daily; massage not necessary
• Children under 12 years of age: Consult physician


Inactive Ingredients:



Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Gluconolactone Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water


Questions Or Comments:



1-800-246-3733


Package Labeling:



Label - Label

Label - Label


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