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.

Drug Facts




Active Ingredients



Menthol 7%


Purpose



Topical analgesic


Uses



Temporarily relieves aches and pains of joints and muscles associated with: • backache • arthritis • bursitis • tendonitis • 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

If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.


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
• cut the patch to fit smaller areas
• 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.


Inactive Ingredients



Acrylic Adhesive, Aloe Vera (Aloe Barbadensis) Extract, Wild Celery (Angelica Anomala) Extract, Arnica (Arnica Montana) Extract, Safflower (Carthamus Tinctorius) Extract, Camphor (Cinnamomum Camphora) Extract, Chinese Cinnamon (Cinnamomum Cassia) Extract, Mandarin Orange (Citrus Reticulata) Extract, Myrrh (Commiphora Molmol) Extract, Turmeric (Curcuma Longa) Extract, White Turmeric (Curcuma zedoaria) Extract, Dragon's Blood (Daemonorops Draco) Extract, Basket Fern (Drynaria Fortunei) Extract, Mastic Sap (Pistacia Lentiscus) Extract, Tibetan Rhubarb (Rheum Officinale) Extract, Baikal Skullcap (Scutellaria Baicalensis) Extract.


Packaging




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