SINSINPAS COLD PATCH

Manufacturer
Sinsin Pharmaceutical Co., Ltd.
Effective date
2024-01-05
Label type
HUMAN OTC DRUG LABEL
Version
19
Source
full-release
Hydrated at
2026-06-01 00:06:46

Label at a glance#

ProductSINSINPAS COLD
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

For the temporarily relief of minor aches and pains of muscles and joints associated with: Arthritis  Simple backache  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 for 7 days Remove patch from skin after at most 8 hours’ application Children undress 12 years of age: consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

L-Menthol (5%)

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

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.

Uses

INDICATIONS & USAGE SECTION

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

  • Arthritis 
  • Simple backache 
  • Strains
  • Bruises 
  • Sprains

Warnings

WARNINGS SECTION

For external use only


Do not use

  • on wounds or damaged skin
  • if you are allergic to any ingredients of this product
  • with a heating pad
  • with, or at the same time as, other external analgesic products

When using this product

  • do not use otherwise than directed
  • avoid contact with eyes, mucous membranes or rashes
  • do not bandage tightly

Ask a doctor before use if you are prone to allergic reaction from aspirin or salicylates

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.

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 for 7 days
  • Remove patch from skin after at most 8 hours’ application

Children undress 12 years of age: consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe vera gel, BHT, Castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydoxide gel, gelatin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methyl paraben, PEG monostearte, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate.

SINSINPAS COLD PATCH

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SINSINPAS COLD PATCH LABELSINSINPAS COLD PATCH LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN19
420222menthol 0.05 MG/MG Medicated PatchSCD19
420222menthol 5 % Medicated PatchSY19

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-104-01SINSINPAS COLD17 g in 1 PATCHPATCH1719
55264-104-02SINSINPAS COLD4 in 1 POUCHPATCH419

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-104SINSINPAS COLD (L-MENTHOL) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]19Legacy NDC, 2 package rows20240106_730e54c9-7dbc-4c0a-919c-3e8cb625e144.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55264-10455264-104-01, 55264-104-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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
0e3cb18b-0257-3807-e063-6394a90a3793730e54c9-7dbc-4c0a-919c-3e8cb625e1442024-01-05WarningsExact identifier
spl id: 0e3cb18b-0257-3807-e063-6394a90a3793
spl set id: 730e54c9-7dbc-4c0a-919c-3e8cb625e144

Reported adverse events (FAERS/openFDA)#

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