FDA Label for Smartrx Natural Pain Relief Sleeve Elbow

View Indications, Usage & Precautions

Smartrx Natural Pain Relief Sleeve Elbow Product Label

The following document was submitted to the FDA by the labeler of this product Niche Brands, 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.

Smartrx Natural Pain Relief Sleeve Elbow





Active Ingredient



Methyl Salicylate 10%


Purpose



External Analgesic (Counterirritant)


Use



for the temporary relief of minor aches and pains of muscles and joints associated with • arthritis • strains • bruises • sprains.


Warnings



For external use only. Avoid contact with the eyes.


When Using This Product



  • Do not use otherwise than as directed.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use in conjunction with liniments, balms or lotions.
  • Do not use on damaged or broken skin.

Stop Use And Ask A Doctor If



  • Redness is present.
  • Excessive irritation of skin develops.
  • Condition worsens, or if symptoms persist for more than 7 days.

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children



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


Directions



Open pouch and remove. Pull woven sleeve containing external analgesic pads over ankle, positioning on either side of affected area.

  • Adults and children 3 years of age and older: Apply to the affected area not more than 3 to 4 times daily.
  • Children under 3 years of age: Consult a physician.

Other Information:



  • Store away from direct sunlight.
  • For your protection, this sleeve has been sealed in an aluminum pouch.
  • Do not use if tamper evident seal is missing, tampered, broken or destroyed.

Allergy Warning:



Contains Macadamia nut oil.


Inactive Ingredients



Macadamia nut oil, citronella oil, mandarin oil, coriander oil and rosemary oil.


Questions?:



000-000-0000


Smartrx Natural Pain Relief Sleeve Elbow 1 Count (60589-003-00)




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