Lidocaine Pain Relieve Gel-Patch

Manufacturer
Henan Kangdi Medical Devices Co., Ltd
Effective date
2026-02-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:37:24

Key Label Information#

Active Ingredients And Purpose

Active Ingredient

LIDOCAINE 4%

Purpose

Topical Analgesic

Uses

Use

For temporary relief of pain

Warnings

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

Directions And Dosage

Directions

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

Other Label Information

Other information

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

Inactive ingredients

Dihydroxyaluminum Aminoacetate,Edetate Disodium,Glycerin,Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral oil.Polysorbate 80, Polyacrylic Acid,Polyvinylpyrrolidone K90,Propylene Glycol, Sodium Polyacrylate,Titanium Dioxide,Water.

Questions

Healthpatchofficial@gmail.com

PRINCIPAL DISPLAY PANEL

Label Images#

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1
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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN3
1737778lidocaine 0.04 MG/MG Medicated PatchSCD3
1737778lidocaine 4 % 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
69561-005-012026-01-29C16284748780-149896155-ac76-586f-e063-e6dba90add9069561-005-01
69561-005-022026-01-29C16284748780-149896155-ac76-586f-e063-e6dba90add9069561-005-01
69561-005-032026-01-29C16284748780-149896155-ac76-586f-e063-e6dba90add9069561-005-01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69561-005-01Lidocaine Pain Relieve Gel-Patch10 in 1 BOXPATCH103
69561-005-01Lidocaine Pain Relieve Gel-Patch12 g in 1 PATCHPATCH123
69561-005-02Lidocaine Pain Relieve Gel-Patch12 g in 1 PATCHPATCH123
69561-005-02Lidocaine Pain Relieve Gel-Patch18 in 1 BOXPATCH183
69561-005-03Lidocaine Pain Relieve Gel-Patch30 in 1 BOXPATCH303
69561-005-03Lidocaine Pain Relieve Gel-Patch12 g in 1 PATCHPATCH123

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69561-00569561-005-01, 69561-005-02, 69561-005-03

Ingredients#

Complete SPL Sections#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

LIDOCAINE 4%

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 ■ on wounds or damaged skin ■ with a heating pad ■ if you are allergic to any ingredients of this product

When Using

OTC - WHEN USING SECTION

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

Stop Use

OTC - STOP USE SECTION

■ localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering ■ condition worsen ■ symptoms persist far more than 7 days ■ symptoms clear up and occur again within a few days

Ask Doctor

OTC - ASK DOCTOR SECTION

lf pregnant or breast-feeding

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Dihydroxyaluminum Aminoacetate,Edetate Disodium,Glycerin,Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral oil.Polysorbate 80, Polyacrylic Acid,Polyvinylpyrrolidone K90,Propylene Glycol, Sodium Polyacrylate,Titanium Dioxide,Water.

Questions

OTC - QUESTIONS SECTION

Healthpatchofficial@gmail.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML