SINSINPAS AREX GEL PATCH

Manufacturer
Sinsin Pharmaceutical Co., Ltd.
Effective date
2024-01-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:06:46

Label at a glance#

ProductSINSINPAS AREXGEL
Active ingredientCAMPHOR (SYNTHETIC), LEVOMENTHOL, METHYL SALICYLATE
Label structure9 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 76.8mg

Methyl Salicylate 57.6mg

DL-Camphor 96.0mg

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

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

Ask a doctor before use if you are allergic to any ingredients in this product.

When using this product

  • do not use other than directed
  • avoid contact with eyes, mucous membranes, and rashes

Stop use and ask a doctor if

  • rash, itching, or excessive skin irritation develops
  • condition worsens
  • symptoms persist for longer than 7 days
  • symptoms clear up and reoccur within a few days

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

Caution: This product contains natural rubber latex which may cause allergic reactions.

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

Children undress 12 years of age: consult a doctor

Other Information

OTHER SAFETY INFORMATION

  • Avoid storing product in direct sunlight
  • Protect from excessive moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe vera gel, Butylated hydroxytoluene, Carboxymethylcellulose sodium, Castor oil, Concentrated glycerin, Disodium edetate hydrate, Dihydroxyalumium Aminoacetate, Gelatin, Kaolin, Methylparaben, Nonivamide, Polysorbate 80, Purified water, Sodium polyacrylate, Sorbitol, Tartaric acid, Titanium dioxide

SINSINPAS AREX GEL PATCH

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SINSINPAS AREX GEL PATCHSINSINPAS AREX GEL PATCH

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2568113camphor 96 MG / levomenthol 76.8 MG / methyl salicylate 57.6 MG Medicated PatchPSN3
2568113camphor 96 MG / levomenthol 76.8 MG / methyl salicylate 57.6 MG Medicated PatchSCD3

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
55264-114-01SINSINPAS AREXGEL6 in 1 PATCHPATCH63
55264-114-02SINSINPAS AREXGEL1 in 1 POUCHPATCH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-114SINSINPAS AREXGEL (L-MENTHOL) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]3Legacy NDC, 2 package rows20240106_ca91bdca-0004-6617-e053-2a95a90ad7a0.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
55264-11455264-114-01, 55264-114-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
0e3cb332-0192-23b2-e063-6294a90aed38ca91bdca-0004-6617-e053-2a95a90ad7a02024-01-05WarningsExact identifier
spl id: 0e3cb332-0192-23b2-e063-6294a90aed38
spl set id: ca91bdca-0004-6617-e053-2a95a90ad7a0

Reported adverse events (FAERS/openFDA)#

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