FDA Label for Medicated Pain Relief Hot

View Indications, Usage & Precautions

Medicated Pain Relief Hot Product Label

The following document was submitted to the FDA by the labeler of this product Kareway Product, Inc.. 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



L-Menthol 0.4%

Capsicum Extract (0.002% of Capsaicin)


Purposes



Topical analgesic

Topical analgesic


Uses



Temporarily relieves minor pain associated with:

  • arthritis
  • muscle strains
  • simple backache
  • bursitis
  • cramps
  • tendonitis
  • muscle sprains
  • bruises

Warnings



For external use only


When Using This Product



  • use only as directed
  • do not bandage tightly
  • do not use a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin
  • do not use if you are allergic to any ingredients of this product

Stop Use And Ask A Doctor If



  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

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 right away


Directions



Adults and children 12 years of age and older: Clean and dry affected area. Remove backing film and apply not more than 3 to 4 times daily.

Children under 12 years of age: Consult a physician.


Other Information



Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients



Purified water, Glycerin, Disodium edetate, Tartaric acid, Gelatine, Polyvinyl alcohol, Sodium polyacrylate, Vitamin E acetate, Aloe vera


Package Label



Pain Relief Hot Patch


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