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| Product NDC Code | 72749-008 | ||||
|---|---|---|---|---|---|
| Drug Name | Painfix restore |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 2590922 | ||||
| Application Number | part348 | ||||
| Labeler Name | PainFix LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Menthol 7%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Temporarily relieves aches and pains of joints and muscles associated with: • backache • arthritis • bursitis • tendonitis • cramps • strains • bruises • sprains
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.PainFix Restore Menthol MENTHOL, UNSPECIFIED FORM MENTHOL ALOE VERA LEAF ANGELICA ANOMALA ROOT ARNICA MONTANA WHOLE CARTHAMUS TINCTORIUS FLOWER BUD CINNAMOMUM CAMPHORA RESIN CHINESE CINNAMON CITRUS RETICULATA WHOLE MYRRH TURMERIC CURCUMA ZEDOARIA ROOT DRAGON'S BLOOD DRYNARIA FORTUNEI ROOT PISTACIA LENTISCUS RESIN OIL RHEUM OFFICINALE ROOT SCUTELLARIA BAICALENSIS ROOT
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging Patch-008
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
UNLOCK YOUR BODY TAKE ME WITH YOU! I don't belong in the medicine cabinet. Throw me in your purse or gym bag, or take me along when you're exploring the world or pushing your limits. Think of me as a tool to unlock a higher experience for moments that matter in your life. 1. Peel off the transparent layer 2. Place the patch on the affected area. Use as many as you need. 3. Use each patch for up to 15 hours. 4. For best results, use the patch with the exercises in your personalized regimen. www.painfixbody.com Welcome to our community. Share your # UnlockedBody Story: Made in USA Manufactured for PainFix LLC 195 Plymouth Street, Suite 404 Brooklyn, New York 11201
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store in a cool, dry place, away from direct sunlight.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API