Painfix Restore
FDA Label NDC 72749-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Painfix Llc for the product Painfix Restore (NDC 72749-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Patch-008 (7274900803 4)
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