FDA Label for Biofreeze

View Indications, Usage & Precautions

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 3.5%


Purpose



Cooling Pain Reliever


Uses



Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis - backache - strains - sprain


Warnings



For external use only.


Flammable



Keep away from excessive heat or open flame


Ask A Doctor Before Use If You Have:



sensitive skin


Otc - When Using



  • 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

Stop Use And Ask A Doctor If:



Condition worsens, or of 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 The Reach Of Children:



If accidentally ingested, get medical help or contact a Poison Control Center immediately.


Directions



  • Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary.
  • Children under 2 years of age : Consult physician

Other Information:



Store in a cool dry place with lid closed tightly


Inactive Ingredient



  • carbomer, FD and C blue # 1, FD and C yellow # 5, glycerine, herbal extract (llex paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol, silicon dioxide, triethanolamine, purified water U

Questions Or Comments?



1-330-633-8460


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