FDA.reportPublic FDA data

Pain Relief Gel-Patch

Manufacturer
KORVIA GLOBAL Inc. | Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
Effective date
2025-12-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:22:49

Label at a glance#

ProductPain Relief Gel-Patch
Active ingredientLIDOCAINE
Label structure14 sections

Indications and uses

For temporary relief of pain

Dosage and administration

Adult and Children 12 years of age and over : Clean and dry the affected area Remove film from patch and apply to the skin 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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% ...... Purpose: Topical Anesthetic

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Ask a doctor if:

OTC - ASK DOCTOR SECTION

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persists for more than 7 days
  • Symptoms clear up and occur again within a few days

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly

Do not use

OTC - DO NOT USE SECTION

  • More than 1 patch at a time
  • On wounds or damaged skin
  • with a heating pad or device
  • If you are allergic to any ingredients of this product

Stop use if:

OTC - STOP USE SECTION

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persists for more than 7 days
  • Symptoms clear up and occur again within a few days

Pregnancy or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed accidentally, get medical help or contact with Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and Children 12 years of age and over:

  • Clean and dry the affected area
  • Remove film from patch and apply to the skin
  • 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

Questions or Comments?

OTC - QUESTIONS SECTION


support@PaxiumHealth.com

Inactive ingredients

INACTIVE INGREDIENT SECTION

Dihydroxyaluminum Aminoacetate, Edetate Disodium,Glycerin, Kaolin, Methylparaben, Polysorbate 80,Propylene Glycol, Polyacrylic Acid, Povidone K90,Propylparaben, Sodium Polyacrylate, Tartaric Acid,Titanium Dioxide, Water.

Package label. Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15-patch15-patch30-patch30-patch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD1
1737778lidocaine 4 % Medicated PatchSY1

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
BarcodeEAN-138800352600000GTIN-13: 8800352600000
EAN-13: 8800352600000
GTIN storage (14 digits): 08800352600000		87253-15.jpg
BarcodeEAN-138800352600017GTIN-13: 8800352600017
EAN-13: 8800352600017
GTIN storage (14 digits): 08800352600017		87253_30.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
87253-187-15Pain Relief Gel-Patch1 in 1 BAGPATCH11
87253-187-15Pain Relief Gel-Patch15 in 1 BOXPATCH151
87253-187-30Pain Relief Gel-Patch1 in 1 BAGPATCH11
87253-187-30Pain Relief Gel-Patch30 in 1 BOXPATCH301

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
87253-18787253-187-15, 87253-187-30

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
POLYSORBATE 806OZP39ZG8HIACT
GLYCERINPDC6A3C0OXIACT
POVIDONE K90RDH86HJV5ZIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
EDETATE DISODIUM7FLD91C86KIACT
KAOLIN24H4NWX5COIACT
TARTARIC ACIDW4888I119HIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
LIDOCAINE98PI200987ACTIB

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
Pain Relief Gel-PatchLIDOCAINEKORVIA GLOBAL Inc.45ccfcae-a307-1c5f-e063-6294a90acf892025-12-12WarningsExact identifier
ndc (package): 87253-187-15
ndc (package): 87253-187-30
ndc (product): 87253-187
ndc11 (package): 87253018715
ndc11 (package): 87253018730
spl id: 45ccfce2-c8c2-ac14-e063-6394a90adfdd
spl set id: 45ccfcae-a307-1c5f-e063-6294a90acf89

Reported adverse events (FAERS/openFDA)#

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