FDA Label for Gerigentle Frostyheat Pain Relief Patch 4 Lodocaine Back

View Indications, Usage & Precautions

Gerigentle Frostyheat Pain Relief Patch 4 Lodocaine Back 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



Lidocaine 4%


Purpose



Topical anesthetic


Uses



For temporary relief of pain


Warnings:



For external use only


Do Not Use



  • More than 1 patch at a time
  • 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
  • do not bandage tightly

Stop Use And Ask A Doctor If



  • localized skin reactions, such as rash, itching, redness, pain swelling and blistering develop
  • Condition worsens
  • 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 over 12 years:

  • 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 12 years or younger: consult a physcian

Other Information:



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

Inactive Ingredients:



Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.


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