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  5. Label Information: Painkoolers

FDA Label for Painkoolers

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS:
    3. PURPOSE
    4. USES:
    5. WARNINGS:
    6. DO NOT USE
    7. KEEP OUT OF REACH OF CHILDREN.
    8. STOP USE AND ASK A DOCTOR
    9. DIRECTIONS:
    10. OTHER INGREDIENTS:
    11. STORE
    12. PRODUCT LABEL

Painkoolers Product Label

The following document was submitted to the FDA by the labeler of this product Pure Source, 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.

Drug Facts




Active Ingredients:



Menthol  5.00%

Capsaicin 0.0375%


Purpose



Analgesic/Counterirritant

External Analgesic


Uses:



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


Warnings:



  • For external use only.  Use only as directed.  Avoid contact with eyes and mucous membranes.
  • Do not cover with bandage.

Do Not Use



  • on wounds or damaged skin.
  • in combination with any other external analgesic products.
  • in combination with any external heat source.
  • on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.
  • if you are allergic to Menthol.

Keep Out Of Reach Of Children.



Consult physician for children under 12.


Stop Use And Ask A Doctor



  • if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.
  • if rash, itching or excessive skin irritation occurs.

Directions:



  • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.
  • Children under 12 years, consult physician before use.
  • How to apply:
  • Clean and dry affected area
  • Cut open pouch and remove patch
  • Remove protective film and apply directly to the area of pain
  • Apply to affected area not more than 3 times daily
  • Wash hands with soap after applying patch
  • Reseal pouch containing unsed patches

Other Ingredients:



Water, Glycerine, Sodium Polyacrylate, Polysorbate 80Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt, Diazolidinyl Urea, Methylparaben, Iodoproynyl Butylcabamate, Propylparaben.


Store



 below 25 degrees.  Avoid direct sunlight.


Product Label



PainKoolers Topical Analgesic patch Menthol 5% Capsaicin 0.0375% Designed for better mobility 5 Patches

PainKoolersPatch - PainKoolersPatch

PainKoolersPatch - PainKoolersPatch


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