Capsaicin 0.035 Patch
FDA Label NDC 82461-421

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medcore Llc for the product Capsaicin 0.035 (NDC 82461-421). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, do not use, when using this product, stop use and ask a doctor if, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Capsaicin 0.035%

Purpose

Topical analgesic

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

    • If pregnant or breast-feeding, ask a health professional before use.

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: 82461-421-10

Medcore LLC

Capsaicin 0.035%

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

Figure (Capsaicin 01)

Figure (Capsaicin 01)

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