FDA.reportPublic FDA data

Lidocaine Menthol Pain Relief

Manufacturer
Amerisource Bergen | Foshan Aqua Gel Biotech Co.,Ltd.
Effective date
2026-05-26
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:58:59

Label at a glance#

ProductLidocaine Menthol Pain Relief
Active ingredientLIDOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

Adults and children 2 years of age and over: Clean and dry affected area, free of lotions, ointments and creams Carefully remove backing from patch starting at a corner Apply sticky side of patch to affected area Do not use more than one patch in a 12 hour period Maximum 2 patches per day Discard patch after single use Children under 2 years of age: Do not use, ask a doctor

Storage and handling

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture. Dispose of used patch in a manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

OTC - PURPOSE SECTION

External Analgesic

USES

INDICATIONS & USAGE SECTION

For the temporary relief of pain

WARNINGS

WARNINGS SECTION

  • For External use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

OTC - DO NOT USE SECTION

■over raw surfaces or blistered areas

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • ask a health professional before use.

WHEN USING:

OTC - WHEN USING SECTION

avoid contact with the eyes
do not use more than one patch on your body at a time

Stop use and consult a doctor if

OTC - STOP USE SECTION

skin irritation develops
condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days

DIRECTIONS Adults and children 12 years of age and over:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and over:

Clean and dry affected area, free of lotions, ointments and creams
Carefully remove backing from patch starting at a corner
Apply sticky side of patch to affected area
Do not use more than one patch in a 12 hour period
Maximum 2 patches per day
Discard patch after single use

Children under 2 years of age:

Do not use, ask a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, ethylhexylglycerin, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

STORAGE AND HANDLING SECTION

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture. Dispose of used patch in a manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch

Lidocaine + Menthol Patch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN6
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD6
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY6

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-574-212022-12-16C16284748780-1d6a99b39-6a78-a426-e053-dadaa90af4c2Lidocaine Menthol Pain Relief
46122-574-212022-12-16C16284748780-1d6a99b39-6a78-a426-e053-dadaa90af4c2Lidocaine Menthol Pain Relief
46122-574-212022-12-16C16284748780-1d6a99b39-6a78-a426-e053-dadaa90af4c2Lidocaine Menthol Pain Relief
46122-574-212022-01-28C16284748780-1d6a99b39-6a78-a426-e053-dadaa90af4c2Lidocaine Menthol Pain Relief
46122-574-212022-01-28C16284748780-1d6a99b39-6a78-a426-e053-dadaa90af4c2Lidocaine Menthol Pain Relief
46122-574-212022-01-28C16284748780-1d6a99b39-6a78-a426-e053-dadaa90af4c2Lidocaine Menthol Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-574-21Lidocaine Menthol Pain Relief5 in 1 POUCHPATCH56
46122-574-21Lidocaine Menthol Pain Relief8 g in 1 PATCHPATCH86

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-574-21EA - Each46122-574d0641140-ebee-423f-adf0-986f8bc6562812020-05-08

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46122-57446122-574-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
GLYCERINPDC6A3C0OXIACT
KAOLIN24H4NWX5COIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
PETROLATUM4T6H12BN9UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-03-30monthly-update2026-06-03 18:00:23
42025-12-22monthly-update2026-06-03 17:46:34

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
Lidocaine Menthol Pain ReliefLIDOCAINE, MENTHOLAmerisource Bergen94039190-dde3-4d8e-873a-79abd3f6208b2026-05-26WarningsExact identifier
ndc (package): 46122-574-21
ndc (product): 46122-574
ndc11 (package): 46122057421
spl id: 52bfc22f-31a6-034f-e063-6394a90ab7d0
spl set id: 94039190-dde3-4d8e-873a-79abd3f6208b

Reported adverse events (FAERS/openFDA)#

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