FDA.reportPublic FDA data

SINCERE PAIN RELIEF

Manufacturer
Jiangsu Jiangsu Sincere Pharmaceutical Co., Ltd
Effective date
2016-10-13
Label type
HUMAN OTC DRUG LABEL
Version
3219
Source
full-release
Hydrated at
2026-05-31 22:47:32

Label at a glance#

ProductSINCERE PAIN RELIEF
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure11 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years of age and over: 1. Clean and dry the affected areas. 2. Peel off the protective transparent film, paste the gel surface to the affected area. 3. Remove patch from the skin after at most 12 hours' application. The patch works by cold compression. You may feel cold when using. Children under 12 years of age: Consult a doctor.

Storage and handling

Avoid storing product in direct sunlight. Keep it under seal in cool and dry place.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Menthol  2.0%

Methyl Salicylate  2.0%

Purpose

OTC - PURPOSE SECTION

Menthol                    Topical Analgesic
Methyl Salicylate       Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Simple backache
Arthritis
Sprains
Strains
Bruises

Warnings

WARNINGS SECTION

For external use only.

Do not Use

OTC - STOP USE SECTION

On wounds or damaged skin.

With Other external analgesic products at the same time.

If you are allergic to any ingredients of this product.

Otherwise than as directed.

Avoid contact with the eyes, mucous membranes or rashes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over:
1. Clean and dry the affected areas.
2. Peel off the protective transparent film, paste the gel surface to the affected area.
3. Remove patch from the skin after at most 12 hours' application. The patch works by cold compression. You may feel cold when using.

Children under 12 years of age:
Consult a doctor.

STORAGE AND HANDLING SECTION

Avoid storing product in direct sunlight.
Keep it under seal in cool and dry place.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sodium Polyacrylate (8000 MW), Glycerin, Polysorbate 80, Tartaric Acid, Water

SPL UNCLASSIFIED SECTION

Manufactured by Jiangsu Sincere Pharmaceutical Co.; Ltd.

Building No.8, Boshi Innovation Park NO.101, Nanhai Road, Binhai Industrial Park, Qidong, Jiangsu, China

Phone Number: 86-21-63532920

Made in China

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1812745menthol 2 % / methyl salicylate 2 % Medicated PatchPSN3219
1812745menthol 0.02 MG/MG / methyl salicylate 0.02 MG/MG Medicated PatchSCD3219
1812745menthol 2 % / methyl salicylate 2 % Medicated PatchSY3219

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
70836-001-012020-01-31C16284748780-19d75b9d1-115e-f424-e053-dadaa90a57ceJiangsu Sincere Pharmaceutical Co., Ltd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70836-001-01SINCERE PAIN RELIEF5 in 1 BOXPATCH53219
70836-001-01SINCERE PAIN RELIEF12 g in 1 BAGPATCH123219

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70836-001SINCERE PAIN RELIEF (MENTHOL, METHYL SALICYLATE) PATCH [JIANGSU JIANGSU SINCERE PHARMACEUTICAL CO., LTD]3219Legacy NDC, 2 package rows20161013_6fc4d1f4-1a26-45ae-8f8e-0a81b8344ce4.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70836-00170836-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
TARTARIC ACIDW4888I119HIACT
WATER059QF0KO0RIACT

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
d86006b1-31d6-453a-b2fa-e36fe27f177d6fc4d1f4-1a26-45ae-8f8e-0a81b8344ce42016-10-13WarningsExact identifier
spl id: d86006b1-31d6-453a-b2fa-e36fe27f177d
spl set id: 6fc4d1f4-1a26-45ae-8f8e-0a81b8344ce4

Reported adverse events (FAERS/openFDA)#

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