FDA.reportPublic FDA data

Lidocaine plus Menthol

Manufacturer
Chain Drug Consortium, LLC | Foshan Aqua Gel Biotech Co.,Ltd.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:45:19

Label at a glance#

ProductLidocaine plus Menthol
Active ingredientLIDOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

Temporary relief of minor pain

Dosage and administration

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard after single use. Children under 12 years of age: consult a physician.

Storage and handling

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% Topical Anesthetic

Menthol 1% Topical Anesthetic

OTC - PURPOSE SECTION

Topical Anesthetic

USES

INDICATIONS & USAGE SECTION

Temporary relief of minor pain

WARNINGS

WARNINGS SECTION

  • For External use only. Use only as directed.

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.

DO NOT USE

OTC - DO NOT USE SECTION

■ More than one patch on your body at a time

■ On cut, irritated or swollen skin

■ On puncture wounds

■ For more than one week without consulting a doctor

■ If you are allergic to any active or inactive ingredients

■ If pouch is damaged or opened.

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • Ask a health professional before use.

WHEN USING:

OTC - WHEN USING SECTION

■ Use only as directed

■ Read and follow all directions and warnings on this carton

■ Do not allow contact with the eyes

■ Do not use at the same time as other topical analgesics

■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ Do not microwave

■ Dispose of used patch in 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.

Stop use and consult a doctor if

OTC - STOP USE SECTION

■ Condition worsens

■ Redness is present

■ Irritation develops

■ Symptoms persist for more than 7 days or clear up and occur again within a few days

■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

DIRECTIONS Adults and children 12 years of age and over:

DOSAGE & ADMINISTRATION SECTION

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side
of patch to affected area. Use one patch for up to 12 hours. Discard after single use.
Children under 12 years of age: consult a physician.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol,
propylparaben, PVP, 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.

Distributed By: Pharmacy Value Alliance, LLC Wayne, PA 19087

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidocaine Plus MentholLidocaine Plus Menthol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN3
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD3
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY3

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
68016-876-052022-12-16C16284748780-1d6a99b39-9e13-a426-e053-dadaa90af4c2Lidocaine Plus Menthol
68016-876-052022-01-28C16284748780-1d6a99b39-9e13-a426-e053-dadaa90af4c2Lidocaine Plus Menthol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-876-05Lidocaine plus Menthol8 g in 1 PATCHPATCH83
68016-876-05Lidocaine plus Menthol5 in 1 POUCHPATCH53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-876LIDOCAINE PLUS MENTHOL (LIDOCAINE, MENTHOL) PATCH [CHAIN DRUG CONSORTIUM, LLC]3Legacy NDC, 2 package rows20241222_1d1ecb6f-9447-45d0-8a1f-d5e17efbf0f0.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-87668016-876-05

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
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
GLYCERINPDC6A3C0OXIACT
KAOLIN24H4NWX5COIACT
METHYLPARABENA2I8C7HI9TIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE)9Q5W5G6461IACT
PROPYLPARABENZ8IX2SC1OHIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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
29a5e1c1-d6b0-61f6-e063-6394a90af80b1d1ecb6f-9447-45d0-8a1f-d5e17efbf0f02024-12-19WarningsExact identifier
spl id: 29a5e1c1-d6b0-61f6-e063-6394a90af80b
spl set id: 1d1ecb6f-9447-45d0-8a1f-d5e17efbf0f0

Reported adverse events (FAERS/openFDA)#

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