CAPSAICIN 0.03% PATCH- capsaicin 0.03% patch

Capsaicin 0.03% Patch by

Drug Labeling and Warnings

Capsaicin 0.03% Patch by is a Otc medication manufactured, distributed, or labeled by Medcore LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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

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

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

INGREDIENTS AND APPEARANCE

CAPSAICIN 0.03% PATCH 
capsaicin 0.03% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82461-418
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.03 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
WATER (UNII: 059QF0KO0R)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82461-418-10	10 in 1 CARTON	11/01/2025
1		100 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	11/01/2025

Labeler - Medcore LLC (069802634)