Pain Relief Patch Capsaicin 0.03%

Pain Relief Patch Capsaicin 0.03%
SPL v1
SPL
SPL Set ID 1046c073-c270-4be3-89f2-e8c91f1af97b
Route
TOPICAL
Published
Effective Date 2025-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.03 g)
Inactive Ingredients
Acrylic Acid Polysorbate 80 Glycerin Sorbitol Carboxymethylcellulose Sodium, Unspecified Magnesium Aluminum Silicate Phenoxyethanol Edetate Disodium Lemon Oil, Cold Pressed Water Peppermint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Drug Facts

Uses

For temporary relief of pain

Section 50565-1

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

Section 53414-9

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

Warnings

(​For external use only)

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

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
Active Ingredient

Capsaicin 0.03%

Other Information

Store at room temperature 15°-30°C (59°-86°F)

Avoid storing product in direct sunlight and protect product from excessive moisture.

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.

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

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

Structured Label Content

Drug Facts

Uses

For temporary relief of pain

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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

Purpose

Topical analgesic

Warnings

(​For external use only)

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

Do Not Use (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
Active Ingredient (Active ingredient)

Capsaicin 0.03%

Other Information (Other information)

Store at room temperature 15°-30°C (59°-86°F)

Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive Ingredients (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.

Principal Display Panel (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

When Using 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 (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

Advanced Ingredient Data


Raw Label Data

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