Capsaicin 0.035% Patch

Manufacturer
Medcore LLC
Effective date
2026-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-08 02:02:10

Label at a glance#

ProductCapsaicin 0.035
Active ingredientCAPSAICIN
Label structure13 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Pain Relief Patch

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.035%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

INDICATIONS & USAGE SECTION

Uses For temporary relief of pain

WARNINGS SECTION

Warnings (For external use only)

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.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

FigureFigure

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82461-42182461-421-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Capsaicin 0.035CAPSAICINMedcore LLC1e63d1ce-16f7-4508-bced-bc62e67636732026-09-02WarningsExact identifier
ndc (package): 82461-421-10
ndc (product): 82461-421
ndc11 (package): 82461042110
spl id: 1037be37-fbca-4367-b228-e6c744ad8cff
spl set id: 1e63d1ce-16f7-4508-bced-bc62e6763673

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.