FDA.reportPublic FDA data

Pain Relieveing Gel-Patch

Manufacturer
Bullet point LLC | ShanghaiChuangshiMedicalTechnology(Group)Co.,Ltd.
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:41:47

Label at a glance#

ProductPain Relieveing Gel-Patch
Active ingredientLIDOCAINE
Label structure7 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years old and over:

  • Clean and dry the affected area.
  • Apply 1 patch to the affected area.
  • Do not exceed 1 patch at a time.
  • Leave in place for up to 8 hours.
  • Do not use more than 1 patch in 24 hours unless directed by a doctor.

    Children under 12 years old: ask a doctor.

WARNINGS SECTION

For external use only

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

For temporary relief of pain.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

Topical anesthetic.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

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

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
84008-001-01Pain Relieveing Gel-Patch12 g in 1 PATCHPATCH121
84008-001-02Pain Relieveing Gel-Patch30 in 1 BOXPATCH301

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84008-00184008-001-01, 84008-001-02

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

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 Relieveing Gel-PatchLIDOCAINEBullet point LLC41d507c4-ad37-2686-e063-6394a90aae5b2025-10-23WarningsExact identifier
ndc (package): 84008-001-01
ndc (package): 84008-001-02
ndc (product): 84008-001
ndc11 (package): 84008000102
ndc11 (package): 84008000101
spl id: 41d507c4-ad38-2686-e063-6394a90aae5b
spl set id: 41d507c4-ad37-2686-e063-6394a90aae5b

Reported adverse events (FAERS/openFDA)#

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