FDA.reportPublic FDA data

0.025% Capsaicin Pain relief Patch

Manufacturer
Xuzhou Lanting Pharmaceutical Co., Ltd
Effective date
2025-03-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:11:41

Label at a glance#

Product0.025% Capsaicin Pain relief Patch
Active ingredientCAPSAICIN
Label structure1 sections

Label contents#

Full prescribing information#

0.025% Capsaicin Pain relief Patch, Package NDC Code: 85323-001-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.025% Capsaicin Pain relief Patch, Package NDC Code: 85323-001-00

0.025 Capsaicin Pain relief Patch 85323-001-000.025 Capsaicin Pain relief Patch 85323-001-00

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: 0.025% Capsaicin

Purpose

OTC - PURPOSE SECTION

Purpose: Topical anesthetic

Warnings

WARNINGS SECTION

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.

Uses

DESCRIPTION SECTION

Uses For temporary relief of minor aches & pains of muscles & joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Other information

OTHER SAFETY INFORMATION

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, dihydroxyaluminum aminoacetate anhydrous, edetate disodium, tartaric acid, povidone K90, dmdm hydantoin, polysorbate 80, propylene glycol, carboxymethylcellulose sodium, kaolin, carbomer, sodium polyacrylate, water.

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

INDICATIONS & USAGE SECTION

Uses For temporary relief of minor aches & pains of muscles & joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Adult and children 12 years of age and over:
clean and dry affected area
remove film from patch and apply to the skin (see illustration)
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 apolication
Children under 12 years of age: consult a doctor

DOSAGE & ADMINISTRATION SECTION

Adult and children 12 years of age and over:
clean and dry affected area
remove film from patch and apply to the skin (see illustration)
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043399capsaicin 0.025 % Medicated PatchPSN4
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD4
1043399capsaicin 0.025 % Medicated PatchSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85323-001-000.025% Capsaicin Pain relief Patch5 in 1 BOXPATCH54
85323-001-000.025% Capsaicin Pain relief Patch1 in 1 POUCHPATCH14

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85323-00185323-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
KAOLIN24H4NWX5COIACT
CARBOMER0A5MM307FCIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
GLYCERINPDC6A3C0OXIACT
DMDM HYDANTOINBYR0546TOWIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
WATER059QF0KO0RIACT
TARTARIC ACIDW4888I119HIACT
CAPSAICINS07O44R1ZMACTIB
POVIDONE K90RDH86HJV5ZIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT

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
0.025% Capsaicin Pain relief PatchCAPSAICIN PAIN RELIEF PATCH, CAPSAICIN PAIN RELIEF STRIPXuzhou Lanting Pharmaceutical Co., Ltd2f71193c-6e26-01c4-e063-6394a90a96312025-03-01WarningsExact identifier
ndc (package): 85323-001-00
ndc (product): 85323-001
ndc11 (package): 85323000100
spl id: 3d3c249e-cf71-2e1e-e063-6394a90adbb8
spl set id: 2f71193c-6e26-01c4-e063-6394a90a9631

Reported adverse events (FAERS/openFDA)#

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