FDA Label for Alivio Medicated Pain

View Indications, Usage & Precautions

Alivio Medicated Pain Product Label

The following document was submitted to the FDA by the labeler of this product Alivio Medical Products, Llc. 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 5.00%

Capsacin 0.03%


Purpose



External Analgesic

External Analgesic


Uses:



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


Warnings:



  • For external use only.
  • Avoid contact with eyes.

Do Not



  • apply to open wounds or damages skin.
  • bandage tightly
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children



If swallwed, consult physician.


If Pregnant Or Breast Feeding,



contact physician prior to use.


Directions:



  • Clean and dry affected area.
  • Remove patch from backing and apply to affected area.  Apply directly to effected area.
  • Use only on patch at a time, and a maximum of four patches per day.
  • Leave patch on affected area for up eight hours.
  • Do not use patches for more than five consecutive days.
  • Children under 12 should consult a physician prior to use.

Other Ingredients:



acrylic acid ,aluminum hydroxide .carmellose sodium 2-ethylhexyl acrylate .glycerin . isopropyl myristate .methyl acrylate

nonoxynol-30 .polyacrylate.polyacrylic acid .polysorbate 80 sorbitan sesquioleate starch .talc .tartaric acid. titanium dioxide. water (245-114)


Store



at room temperature.  Avoid direct sunlight


Package Label



Alivio Patch

MEDICATED PAIN PATCH

15 PATCHES

Distributed by:

Alivio Medical Products

Hollywood, FL 33020


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