SINSINPAP COOL

Manufacturer
Sinsin Pharmaceutical Co., Ltd.
Effective date
2025-01-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:51:13

Label at a glance#

ProductSINSINPAP COOL
Active ingredientLEVOMENTHOL, THYMOL, CAMPHOR (SYNTHETIC), PEPPERMINT OIL, EUCALYPTUS OIL
Label structure12 sections

Indications and uses

Temporarily relieves minor pain associated with muscular pain joint pain backache bruise sprain

Dosage and administration

Adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: do not use, consult a doctor For easy application: partially peel back protective film and apply exposed patch to the site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesion.

Storage and handling

avoid storing product in direct sunlight store at room temperature

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

L-Menthol 49.4 mg

Thymol 16.5 mg

DL-Camphor 82.4 mg

Mentha Oil 164.7 mg

Eucalyptus Oil 16.5 mg

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with

  • muscular pain
  • joint pain
  • backache
  • bruise
  • sprain

Warnings

WARNINGS SECTION

For external use only

When using this product:

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly or use with a healing pad
  • avoid contact with the eyes and mucous membranes
  • do not apply to wounds or damaged skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • conditions worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help from hospital right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and over:apply to affected area not more than 3 to 4 times daily.
  • Children under 12 years of age:do not use, consult a doctor
  • For easy application: partially peel back protective film and apply exposed patch to the site of pain.
  • Carefully remove remaining film while pressing patch to skin for secure adhesion.

Storage condition

STORAGE AND HANDLING SECTION

  • avoid storing product in direct sunlight
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

BHT, Castor oil, Concentrated Glycerin, Disodium edetate hydrate, D-sorbitol, Isopropyl myristate, Kaolin, Magnesium aluminometasilicate, Methyl Paraben, PEG-4 stearate, Polysorbate 80, Titanium dioxide, Carboxymethylcellulose Sodium, Sodium Polyacrylate, Polyvinyl alchol, Gelatin, Tataric acid, Purified water

Manufactured by:

SPL UNCLASSIFIED SECTION

SINSIN PHARM. CO., LTD.

Distributed by SS Pharmed USA

Made in Korea

NDC # : 55264-012-01

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sinsin Pap CoolSinsin Pap Cool

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1795944camphor 82.4 MG / eucalyptus oil 16.5 MG / levomenthol 49.4 MG / peppermint oil 164.7 MG / thymol 16.5 MG Medicated PatchPSN5
1795944camphor 82.4 MG / Eucalyptus oil 16.5 MG / levomenthol 49.4 MG / peppermint oil 164.7 MG / thymol 16.5 MG Medicated PatchSCD5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PEPPERMINT Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55264-012-052023-03-15C16284748780-1d6a99b39-8242-a426-e053-dadaa90af4c2SINSINPAP COOL
55264-012-052022-01-28C16284748780-1d6a99b39-8242-a426-e053-dadaa90af4c2SINSINPAP COOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-012-04SINSINPAP COOL5 in 1 POUCHPATCH55
55264-012-05SINSINPAP COOL1 in 1 CARTONPATCH15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-012SINSINPAP COOL (LEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUS) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]5Current NDC, Legacy NDC, 2 package rows20250109_9d47855f-ccb5-4557-a31a-a2b336fa9806.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55264-01255264-012-04, 55264-012-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
ndc (package): 55264-012-05
ndc (package): 55264-012-04
ndc (product): 55264-012
ndc11 (package): 55264001205
ndc11 (package): 55264001204
spl id: 2b28bf4c-b04c-b74a-e063-6394a90ac81c
spl set id: 9d47855f-ccb5-4557-a31a-a2b336fa9806

Reported adverse events (FAERS/openFDA)#

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