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  5. Label Information: Capsaicin 0.03% Patch

FDA Label for Capsaicin 0.03% Patch

View Indications, Usage & Precautions

Table of Contents

    1. ​
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS
    11. OTHER INFORMATION
    12. PRINCIPAL DISPLAY PANEL

Capsaicin 0.03% Patch Product Label

The following document was submitted to the FDA by the labeler of this product Medcore 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.

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Drug Facts


Active Ingredient



Capsaicin 0.03%


Purpose



Topical analgesic


Uses



For temporary relief of pain


Warnings



(​For external use only)


Do Not Use



  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • 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
  • do not bandage tightly

Stop Use And Ask A Doctor If



  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • condition worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Directions



Adult and children 12 years of age and over:

  • clean and dry affected area
  • apply 1 patch at a time to affected area,not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application

    • Children under 12 years of age: consult a doctor


Inactive Ingredients



Poly(acrylic acid) solution,Polysorbate 80,Glycerin,SORBITOL,Carboxymethyl Cellulose Sodium, aluminium magnesium silicate,PHENOXYETHANOL, EDTA Disodium salt,Lemon oil,Water, Peppermint oil.


Other Information



Store at room temperature 15°-30°C (59°-86°F)
Avoid storing product in direct sunlight and protect product from excessive moisture.


Principal Display Panel



NDC: 82461- 418-10

Medcore LLC

Capsaicin 0.03%

Pain Relieving Hydrogel Technology

Contains:

10 Patches

Manufactured for: Medcore LLC 3048 Valley Rd Basking Ridge, NJ 07920

Store in a dry, cool place. For Comments or Questions, call 908-280-2269

Capsaicin - Capsaicin 01

Capsaicin - Capsaicin 01


* Please review the disclaimer below.