FDA Label for Pain Relief Patches

View Indications, Usage & Precautions

Pain Relief Patches Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health, 110 Dba Leader. 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



Active Ingredients Purpose

Camphor 3.1% ......................Topical Analgesic

Menthol 6.0% .......................Topical Analgesic

Methyl Salicylate 10.0% ........Topical Analgesic


For External Use Only



Allergy alert: If prone to allergic reaction from asprin or salicylates, consult a doctor before use


Do Not Use:



  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product

When Using This Product



  • Use only as directed
  • Avoid contact with eyes, mucous membranes or rashes
  • Do not bandage tighly
  • Do not use at the same time as other topical analgesics
  • Dispose of used patch in manner that keeps product away from childrens and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Questions



Customer Care Help Line
1-866-326-1313


Stop Use And Consult A Doctor



  • If rash, itching or excessive skin irritation develops
  • If condition worsens
  • if symptoms last more than 7 days or clear up and occur again with a few days

Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away


Uses



For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises.


Directions



Adults and children 12 years of age and over: Clean and dry affected area. Remove patch from film, apply to affected area not more than 3 to 4 times daily. Remove patch from the skin after at most, 8-hour application.

Children under 12 years of age: consult physician.


Inactive Ingredients



Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer


Indication And Usage



For temporary relief of minor aches and pains.


Pain Relief Patch Label




Other Information: Store in clean, dy place outside of direct sunlight. Protect from excessive moisture.


* Please review the disclaimer below.