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  5. Label Information: Painkoolers Topical Analgesic

FDA Label for Painkoolers Topical Analgesic

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. USES:
    3. WARNINGS:
    4. DO NOT USE
    5. KEEP OUT OF REACH OF CHILDREN
    6. • DO NOT USE
    7. • STOP USE
    8. DIRECTIONS:
    9. HOW TO APPLY:
    10. INACTIVE INGREDIENTS:
    11. PACKAGE LABELING:

Painkoolers Topical Analgesic 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%


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 muccous membranes.

• Do not cover ​with bandage


Do Not Use



on wounds or damaged skin • ​ Do not use ​in combination with any other external analgesic products • Avoid contact with eyes and maccous membranes •  ​Do not use ​in combination with any external heat source. • ​ Do not use ​on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment


Keep Out Of Reach Of Children



• Consult physician for children under 12


• Do Not Use



if you are allergic or amenthol


• Stop Use



and ask a doctor id 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.


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 protected 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

Inactive Ingredients:



Purified Water,Glycerin,Polyvinyl Alcohol,Sodium Polyacrylate,Propylene Glycol,Polysorbate 80,Sorbitan Stearate,Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aanica Montana Extract, Rosemary Oil,Tartaric Acid,Dihydroxyaluminum Aminoacetate,Titanium Dioxide,Kaolin,Glydant Plus Liquid.


Package Labeling:



label - label

label - label


* Please review the disclaimer below.