Capsaicin 0.03% Patch

Manufacturer: Medcore LLC
Effective date: 2025-11-04
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:42:12

Label at a glance#

ProductCapsaicin 0.03% Patch

Active ingredientCAPSAICIN

Label structure9 sections

Indications and uses

For temporary relief of pain

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.

Contacts and useful links#

PhoneLabel contact908-280-2269

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.03%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

(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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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- 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2727393	capsaicin 0.03 % Medicated Patch	PSN	1
2727393	capsaicin 0.0003 MG/MG Medicated Patch	SCD	1
2727393	capsaicin 0.03 % Medicated Patch	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82461-418-10	Capsaicin 0.03% Patch	100 g in 1 PATCH	PATCH	100		1
82461-418-10	Capsaicin 0.03% Patch	10 in 1 CARTON	PATCH	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82461-418-10	EA - Each	82461-418	9c1f761a-2e13-42f3-bbc6-931103a8c41d	1	2026-01-08

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Capsaicin 0.03% Patch
Capsaicin 0.03%
CAPSAICIN
ACRYLIC ACID
POLYSORBATE 80
GLYCERIN
SORBITOL
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
MAGNESIUM ALUMINUM SILICATE
PHENOXYETHANOL
EDETATE DISODIUM
LEMON OIL, COLD PRESSED
WATER
PEPPERMINT OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82461-418	82461-418-10

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
CAPSAICIN	S07O44R1ZM	ACTIB
ACRYLIC ACID	J94PBK7X8S	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
GLYCERIN	PDC6A3C0OX	IACT
SORBITOL	506T60A25R	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	K679OBS311	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
LEMON OIL, COLD PRESSED	I9GRO824LL	IACT
WATER	059QF0KO0R	IACT
PEPPERMINT OIL	AV092KU4JH	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Capsaicin 0.03% Patch	CAPSAICIN 0.03%	Medcore LLC	1046c073-c270-4be3-89f2-e8c91f1af97b	2025-11-04	Warnings	Exact identifier ndc (package): 82461-418-10 ndc (product): 82461-418 ndc11 (package): 82461041810 spl id: 1f68a068-2ae3-476e-92e3-4b03c0f0762f spl set id: 1046c073-c270-4be3-89f2-e8c91f1af97b

Reported adverse events (FAERS/openFDA)#

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