FDA Label for Gerigentle Frostyheat Pain Relief Patch Arm And Neck

View Indications, Usage & Precautions

Gerigentle Frostyheat Pain Relief Patch Arm And Neck Product Label

The following document was submitted to the FDA by the labeler of this product Geri-gentle Corporation. 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 Ingredient



Menthol 5%


Purpose



Topical anesthetic


Use



  • Temporarily relieves minor aches and pains of muscles and joints due to
  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises.

Warnings:



For external use only


Do Not Use



  • on wounds or damaged skin
  • with heating pad
  • if you are allergic to any ingredient of this product.

When Using This Product



  • use only as directed
  • avoid contact with eyes and mucous membranes or rashes

Stop Use And Ask A Doctor If



  • conditions worsen
  • excessive redness or irritation is present
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days.

If Pregnant Or Breast-Feeding,



ask a health care professional before use.


Keep Out Of Reach Of Children And Pets.



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


Directions:



Adults and children 12 years of age and over:Clean and dry affected area.

  • clean and dry affected area
  • remove film from patch and apply to skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily.
  • wear each patch up to 8 hours maximum.
  • Children under 12 years of age: consult a physician.


Other Information:



  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredients:



Glycerin, Sodium polyacrylate, Dihydroxyaluminum Aminoacetate, Methylparaben, Propylparaben, Titanium Dioxide, Kaolin, Polysorbate 80, Propylene Glycol, Tartaric Acid, PVP, Polyacrylic Acid, Water, Petrolatum, CMC, Mineral Oil.


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