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  5. Label Information: Painkoolers Topical Analgesic Patch

FDA Label for Painkoolers Topical Analgesic Patch

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. OTC - PURPOSE
    3. USES:
    4. WARNINGS:
    5. KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS:
    7. OTHER INGREDIENTS:
    8. PACKAGE LABEL

Painkoolers Topical Analgesic Patch Product Label

The following document was submitted to the FDA by the labeler of this product Ga Health And Beauty (foshan) Co., Ltd. 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:



Menthol 5.00%
Capsaicin 0.05%


Otc - 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.
  • Do not use if you are allergic to Menthol.
  • 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.
  • Or Rash, itching or excessive skin irritation occurs.

Keep Out Of Reach Of Children.



Consult Physician for children under 12.


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 area of pain
    Apply to affected area not more than 3 times daily
    Wash hands with soap after applying patch
    Reseal pouch containing unused patches


Other Ingredients:



Water, Glycerine, Sodium Polyacrylate, Polyscorbate 80, Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt, Diaxolidinyl Urea, Methylparaben, Iodoproynyl Butylcarbamate, Propylparaben.


Package Label



Painkoolers - Painkoolers

Painkoolers - Painkoolers


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