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  5. Label Information: Capsaicin Pain Relief

FDA Label for Capsaicin Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABEL

Capsaicin Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Kareway Product, 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.

Active Ingredient



Capsicum extract 0.025% as Capsaicin


Purpose



Topical analgesic


Uses



For temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings



For external use only.

Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower.


Do Not Use



  • on wounds or damaged skin
  • with a heating pad
  • with, or at the same times as other external analgesic products
  • if you are allergic to any ingredients of this product

When Using This Product



  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes

Stop Use And Ask A Doctor If



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

Keep Out Of Reach Of Children.



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


Directions



Adults and children 12 years of age and over:

  • Clean and dry affected area
  • Remove patch from film
  • Apply to affected area not more than 3 to 4 times daily for 7 days
  • Remove patch from the skin after at most 8 hour's application
    • Children under 12 years of age:
    • Consult a doctor


Other Information



  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredients



Butylated Hydroxytoluene, Hydrogenated Rosin Glycerol Ester, Maleated Rosin Glycerin Ester, Natural Rubber, Polybutene, Polyisobutylene, Silicon Dioxide, Titanium Dioxide, Zinc Oxide


Package Label



Capsaicin Hot Patch


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