FDA.reportPublic FDA data

4% lidocaine plus 1% menthol 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 01:11:42

Label at a glance#

Product4% lidocaine plus 1% menthol Pain Relief Patch
Active ingredientLEVOMENTHOL, LIDOCAINE HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

4% lidocaine plus 1% menthol Pain Relief Patch, Package NDC Code: 85323-003-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4% lidocaine plus 1% menthol Pain Relief Patch, Package NDC Code: 85323-003-00

4 lidocaine plus 1 menthol Pain Relief Patch 85323-003-00.4 lidocaine plus 1 menthol Pain Relief Patch 85323-003-00.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: ​4% lidocaine, 1% menthol

Purpose

OTC - PURPOSE SECTION

Purpose: Topical anesthetic

Uses

DESCRIPTION SECTION

Uses For temporary relief of pain

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.

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

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

Directions

INDICATIONS & USAGE SECTION

Uses For temporary relief of pain

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN4
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD4
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85323-003-004% lidocaine plus 1% menthol Pain Relief Patch1 in 1 POUCHPATCH14
85323-003-004% lidocaine plus 1% menthol Pain Relief Patch5 in 1 BOXPATCH54

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85323-00385323-003-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
LEVOMENTHOLBZ1R15MTK7ACTIB
WATER059QF0KO0RIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
KAOLIN24H4NWX5COIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE DISODIUM7FLD91C86KIACT
CARBOMER0A5MM307FCIACT
TARTARIC ACIDW4888I119HIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONE K90RDH86HJV5ZIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
DMDM HYDANTOINBYR0546TOWIACT

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
4% lidocaine plus 1% menthol Pain Relief PatchPAIN RELIEF PATCH, PAIN RELIEF STRIPXuzhou Lanting Pharmaceutical Co., Ltd2f98ee5e-e4eb-fbda-e063-6394a90a709c2025-03-01WarningsExact identifier
ndc (package): 85323-003-00
ndc (product): 85323-003
ndc11 (package): 85323000300
spl id: 3d3bf989-ea47-406f-e063-6294a90a816a
spl set id: 2f98ee5e-e4eb-fbda-e063-6394a90a709c

Reported adverse events (FAERS/openFDA)#

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