SINSINPAS CAPSAICIN HOT PATCH LARGE

Manufacturer
Sinsin Pharmaceutical Co., Ltd.
Effective date
2024-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:46

Label at a glance#

ProductSINSINPAS HOT LARGE
Active ingredientCAPSAICIN
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Strains Bruises Sprains

Dosage and administration

Adults and children 12 years of age and over: Clean and dry affected area Remove patch from film Apply to affected area no more than 3 to 4 times daily Remove patch from skin after at most 8 hours’ application Children under 12 years of age: consult a doctor

Storage and handling

Other information avoid storing product in direct sunlight protect product from excessive moisture

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Capsicum extract 0.025% as Capsaicin

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings

WARNINGS SECTION

For external use only



Do not use

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

When using this product

  • do not use otherwise than directed
  • avoid contact with eyes, mucous membranes or rashes
  • do not bandage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower

Stop use and ask a doctor if

  • rash, itching, or excessive skin irritation develops
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

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

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over:

  • Clean and dry affected area
  • Remove patch from film
  • Apply to affected area no more than 3 to 4 times daily
  • Remove patch from skin after at most 8 hours’ application

Children under 12 years of age:consult a doctor

Other information

STORAGE AND HANDLING SECTION

Other information

  • avoid storing product in direct sunlight
  • protect product from excessive moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

butyl hydroxytoluene, glyceryl rosinate, isopropryl myristate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, propylene carbonate, sorbitan stearate, terpene resin (quinton), terpene resin (YS resin), titanium oxide, zinc oxide

Distributed by:

SPL UNCLASSIFIED SECTION

SINSIN Pharm America

Brea, CA 92821

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SINSINPAS CAPSAICIN LARGESINSINPAS CAPSAICIN LARGE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043399capsaicin 0.025 % Medicated PatchPSN2
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD2
1043399capsaicin 0.025 % Medicated PatchSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55264-110-012026-01-29C16284748780-149896155-a4f6-586f-e063-e6dba90add90SINSINPAS CAPSAICIN HOT PATCH LARGE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-110-01SINSINPAS HOT LARGE3 in 1 PATCHPATCH32
55264-110-01SINSINPAS HOT LARGE1 in 1 POUCHPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-110SINSINPAS HOT LARGE (CAPSAICIN) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2Legacy NDC, 2 package rows20240106_c5f08d1b-3b56-535a-e053-2995a90afa65.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55264-11055264-110-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
0e3cbb1d-3c32-392e-e063-6394a90ac8c7c5f08d1b-3b56-535a-e053-2995a90afa652024-01-05WarningsExact identifier
spl id: 0e3cbb1d-3c32-392e-e063-6394a90ac8c7
spl set id: c5f08d1b-3b56-535a-e053-2995a90afa65

Reported adverse events (FAERS/openFDA)#

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