SINSINPAS LIDOCAINE PAIN RELIEVING PATCH

Manufacturer
Sinsin Pharmaceutical Co., Ltd.
Effective date
2025-10-07
Label type
HUMAN OTC DRUG LABEL
Version
28
Source
full-release
Hydrated at
2026-06-01 01:38:09

Label at a glance#

ProductSINSINPAS LIDOCAINE PAIN RELIEVING
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

For the temporarily relief of minor pain

Dosage and administration

Adults and children 12 years of age and over: clean and dry affected area remove film from patch by gently pulling apart from corner carefully apply to afftcted area once patch is positioned, press firmly to adhere to skin use only one patch at a time for up the 12 hours Children under 12 years of age: consult a professional

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Keep out of reach of children or pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children or pets.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)

Uses

INDICATIONS & USAGE SECTION

For the temporarily relief of minor pain

Warnings

WARNINGS SECTION

For external use only



Do not use

  • more than 1 patch at a time
  • on broken, irritated, or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When using this product

  • use only as directed. Read and follow all direction and warning on this label
  • Avoid contact with the eyes or mucous membranes
  • Do not apply to broken, damaged, or irritated skin
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Rare cases of serious burns have been reported with products of this type
  • Do not use with other topical analgesics
  • Keep children and pets away from used or disposed patch.
  • Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this product.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove film from patch by gently pulling apart from corner
  • carefully apply to afftcted area
  • once patch is positioned, press firmly to adhere to skin
  • use only one patch at a time for up the 12 hours

Children under 12 years of age: consult a professional

Inactive Ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene
carboxymethylcellulose sodium
glycerin
edetate disodium
isopropyl myristate
kaolin
magnesium aluminosilicate
methyl acrylate and 2-ethylhexyl acrylate copolymer aqueous emulsion (mixture)
methyl paraben
polyacrylic acid
polysorbate 80
propylene glycol
propyl paraben
purified water
sodium polyacrylate
sorbitan sesquioleate
tartaric acid
urea

SINSINPAS LIDOCAINE PAIN RELIEVING PATCH

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

02-25-201902-25-2019

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN28
1737778lidocaine 0.04 MG/MG Medicated PatchSCD28
1737778lidocaine 4 % Medicated PatchSY28

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
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
55264-106-01SINSINPAS LIDOCAINE PAIN RELIEVING14 g in 1 PATCHPATCH1428
55264-106-02SINSINPAS LIDOCAINE PAIN RELIEVING1 in 1 POUCHPATCH128
55264-106-03SINSINPAS LIDOCAINE PAIN RELIEVING5 in 1 BOXPATCH528

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55264-10655264-106-01, 55264-106-02, 55264-106-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
262025-06-19full-release2026-06-01 01:03:30

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
SINSINPAS LIDOCAINE PAIN RELIEVINGLIDOCAINESinsin Pharmaceutical Co., Ltd.82c0a036-8750-5b3d-e053-2a91aa0a18152025-10-07WarningsExact identifier
ndc (package): 55264-106-02
ndc (package): 55264-106-03
ndc (package): 55264-106-01
ndc (product): 55264-106
ndc11 (package): 55264010601
ndc11 (package): 55264010602
ndc11 (package): 55264010603
spl id: 40969e2f-7ecb-0030-e063-6294a90aa30a
spl set id: 82c0a036-8750-5b3d-e053-2a91aa0a1815

Reported adverse events (FAERS/openFDA)#

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