FDA Label for Painfix Restore

View Indications, Usage & Precautions

Painfix Restore Product Label

The following document was submitted to the FDA by the labeler of this product Painfix 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 3%


Purpose



`Topical analgesic


Uses



Temporarily relieves aches and pains of joints and muscles associated with: • backache • arthritis • bursitis • tendonits • cramps • strains • bruises • sprains


Warnings



Avoid direct contact with eyes. For external use only.


When Using This Product



• use only as directed • avoid contact with eyes or mucous membranes • do not apply local heat to the area of use • do not apply to wounds, broken, damaged or irritated skin


Stop Use And Ask A Doctor If



• condition worsens or symptoms persist for more than 7 days • skin irritation develops or you experience signs of skin injury, such as pain, swelling, or blistering where product is applied


Keep Out Of Reach Of Children.



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


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Directions



Adults and children above 12 years:

  • open pouch and remove patch
  • peel off protective backing and carefully apply sticky side to affected area
  • if affected area is large, use more than one patch for best results
  • use each patch for up to 15 hours
  • apply a new patch each day
  • to better keep the patch in place, use the provided adhesive plasters
  • for best results, use with recommended exercises
  • Children 12 years and younger, ask a health professional


Other Information



Store in a cool, dry place, away from direct sunlight.


Ingredients



Aloe barbadensis extract, Aluminum glycinate, Angelica anomala extract, Carthamus tinctorius extract, Cinnamomum camphora extract, Cinnamomum cassia extract, Citrus reticulata extract, Commiphora molmol extract, Curcuma longa extract, Curcuma zedoaria extract, Daemonops draco extract, Disodium EDTA, Drynaria fortunei extract, Glycerine, Glyceryl stearate, Kaolin, Methylparaben, PEG-40 hydrogenated castor oil, Pistacia lentiscus extract, Polyvinylpyrrolidone, Rheum officinale extract, Sodium polyacrylate, Scutellaria baicalenis extract, Tartaric acid, Water (Aqua)


Package Labeling:




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