FDA.reportPublic FDA data

DRMITSUI Lidocaine 4% Pain Relieving Gel

Manufacturer
Guangzhou Ruyu Cosmetics Co., Ltd
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:25:42

Label at a glance#

ProductDRMITSUI Lidocaine 4% Pain Relieving Gel
Active ingredientLIDOCAINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% ----
PURPOSE
Topical analgesic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - PURPOSE SECTION

Uses for temporary relief of pain:
1.Fold sides back, pull apart to expose adhesive. 2.Place on affected area. 3.Peel off one side of the film. 4.Peel off the
remaining film.5.Press and smooth patch to secure.

WARNINGS SECTION

For external use only

Do not use:
1.More than 1 patch at atime. 2.0n wounds or damaged skin. 3.With a heating pad. 4.lf you are allergic to any ingredients
of this product.

DOSAGE & ADMINISTRATION SECTION

Apply 1 patch at a time
to affected area, not more than 3 to 4 times daily

INDICATIONS & USAGE SECTION

Adults and children 12 years of age and over:
1. Clean and dry affected area. 2.Remove film from patch and apply to the skin (see illustration). 3.Apply 1 patch at a time
to affected area, not more than 3 to 4 times daily. 4.Remove patch from the skin after at most 8-hour application.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS
ALUMINUM SILICATE, DIHYDROXYALUMINUM AMINOACETATE, DISODIUM EDETATE, GELATIN, GLYCERIN, METHYLPARABENOLEIC ACID, POLYACRYLIC ACID, POLYVINYL ALCOHOL, PROPYLENE GLYCOL, PROPYLPARABEN, SODIUM POLYACRYLATETARTARIC ACID, TITANIUM DIOXIDE, WATER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

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
85713-102-01DRMITSUI Lidocaine 4% Pain Relieving Gel6 in 1 BOXPATCH61
85713-102-01DRMITSUI Lidocaine 4% Pain Relieving Gel10 g in 1 PATCHPATCH101

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
85713-10285713-102-01

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
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
POLYVINYL ALCOHOL532B59J990IACT
TARTARIC ACIDW4888I119HIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
ALUMINUM SILICATET1FAD4SS2MIACT
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM7FLD91C86KIACT

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
460d6b66-1788-df4f-e063-6294a90a4c2e460d6b66-1787-df4f-e063-6294a90a4c2e2025-12-16WarningsExact identifier
spl id: 460d6b66-1788-df4f-e063-6294a90a4c2e
spl set id: 460d6b66-1787-df4f-e063-6294a90a4c2e

Reported adverse events (FAERS/openFDA)#

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