FDA Label for Protec Pain Relief Cold Therapy

View Indications, Usage & Precautions

Protec Pain Relief Cold Therapy Product Label

The following document was submitted to the FDA by the labeler of this product Ahc Ventures. 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 Ingredient



Menthol USP 8.0%


Purpose



Pain Reliever


Uses:



Temporary relieves minor aches and pains associated with

  • sore muscles and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises

Warnings:



For external use only


When Using This Product:



  • Use only as directed
  • Do not bandage or use a heating pd or device
  • Avoid contact with eyes and mucous membranes
  • Do not apply to open wounds or damaged skin
  • Do not use with other ointments, creams, sprays, liniments
  • After applying wash hands thoroughly with cool water

Stop Use And Ask Doctor If:



  • condition worsens or symptoms persist for more than 7 days or clear up and recur
  • Redness is present or irritation develops

If Pregnant Or Breast Feeding



Ask a health professional before use


Keep Out Of Reach Of Children:



In case of accidential ingestion get medical help or contact a Poison Control Center immediately


Directions:



Adults and children 2 years of age and older: Spray directly onto affected area without the need to rub, massage or bandage. Repeat as necessary but do not apply more the 4 times daily
Children under 2 years of age: Consult a Physician


Other Information:



Store in a cool dry place with lid or cap closed tightly.
Flammable: Keep away from excessive heat or open flame


Inactive Ingredients



Ilex Paraguariensis Leaf Extract, Arnica, Boswellia Serrata, Eucalyptus Oil, Peppermint Oil, Hyaluronic Acid, Yucca Extract, Nitric Oxide, Dimethyl Sulfone, Citric Acid, SD Alcohol 39 C, Purified Water


* Please review the disclaimer below.