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


Warnings:



For external use only


When Using This Product:




■ use only as directed
■ avoid contact with the eyes or on mucous membranes
■ do not apply to wounds or damaged skin
■ do not apply to irritated skin or if excessive irritation develops
■ do not bandage tightly or 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 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 area not more
than 3 to 4 times daily
■ children under 12 years of age: consult a physician


■ wash hands after use with cool water


Inactive Ingredients:




Alcohol, Calcium Gluconate, Caprylic/Capric Triglyceride,
Caprylyl Glycol, Cetostearyl Alcohol, Dimethicone, Edetate Sodium, Fragrance, Gluconolactone, Glycerin,
Glyceryl Stearate, Grapeseed Oil Refined, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract,
Iodopropynyl Butylcarbamate, Isopropyl Alcohol, PEG-4 Laurate, Phenoxyethanol, Polysorbate 60,
PurifiedWater, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tocopheryl Acetate


Questions Or Comments:



1-800-246-3733


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