FDA.reportPublic FDA data

LIDOCAINE, MENTHOL

Manufacturer
Planet (Anhui) Pharmaceutical Co., Ltd.
Effective date
2026-03-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:49:29

Label at a glance#

ProductCareland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with border
Active ingredientLIDOCAINE, MENTHOL
Label structure8 sections

Dosage and administration

Adults 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 film from patch and apply to skin Children under 12 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4.0%

Menthol 1.0%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Use

INDICATIONS & USAGE SECTION

For temporary relief of pain

WARNINGS

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • more than 1 patch at a time
  • with a heating pad 
  • on wounds or damaged skin 
  • if you are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly
  • avoid contact with the eyes, mucous membranes of rashes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms persist for more than 7 days
  • conditions worsen 
  • symptoms clear up and occur again within a few days
  • localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults 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 film from patch and apply to skin

Children under 12 years of age:consult a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Azone,Castor oil,Dihydroxyaluminum Aminoacetate,Disodium edetate dihydrate,Fumed silica,Glycerol,Isopropyl Myristate, Polyacrylic Acid,Polysorbate 80,Propylene Glycol,Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide,Urea,water

QUESTIONS?

OTC - QUESTIONS SECTION

626-839-9001 Service@getcareland.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128X00418A4TZLabel3.jpg

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
75568-014-01Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with border9.1 g in 1 BAGPATCH9.16
75568-014-01Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with border20 in 1 BOXPATCH206

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
75568-01475568-014-01

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
LAUROCAPRAM1F3X9DRV9XIACT
CASTOR OILD5340Y2I9GIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
UREA8W8T17847WIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB

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
Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with borderLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.1fda69f7-2bb6-42fc-bcef-677e7b3d7f012026-03-09WarningsExact identifier
ndc (package): 75568-014-01
ndc (product): 75568-014
ndc11 (package): 75568001401
spl id: 4c9ccfdd-f17e-25e6-e063-6294a90a8ec0
spl set id: 1fda69f7-2bb6-42fc-bcef-677e7b3d7f01

Reported adverse events (FAERS/openFDA)#

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