Arex Sinsin Pas

Manufacturer
Sinsin Pharmaceutical Co., Ltd.
Effective date
2025-10-07
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:38:04

Label at a glance#

ProductAREX SINSIN PAS
Active ingredientLEVOMENTHOL, METHYL SALICYLATE, ZINC OXIDE, CAMPHOR (SYNTHETIC), PEPPERMINT OIL
Label structure10 sections

Indications and uses

For temporary 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 not more than 3 to 4 times daily for 7 days. Remove patch from skin after at most 8 hours application. Children under 12 years of age: Consult a doctor.

Storage and handling

avoid storing product in direct sunlight protect from excessive moisture

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

DL-Camphor 17.05mg

L-Menthol 45.45mg

Mentha Oil 22.73mg

Methyl Salicylate 45.45mg

Zinc Oxide 215.91mg

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Do not use

WARNINGS SECTION

  • on wounds or damaged skin
  • if you are allergic to aspirin or salicylates
  • with a heating pad
  • with, or at the same time as, other external analgesic products.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Caution:

WARNINGS AND PRECAUTIONS SECTION

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

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 not more than 3 to 4 times daily for 7 days.
  • 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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl Nicothinamide, Butylated Hydroxytoluene, Calcium Carbonate, Glyceryl Rosinate, Natural Rubber, Polyisobutylene, Polybutene, Quintone, Vanillyl Nonylamide, YS Resin.

FDA NDC No.: 55264-020-10

Manufactured by:

SPL UNCLASSIFIED SECTION

SINSIN PHARM. CO., LTD.

90, Beomjigi-ro 141 beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea

tel: 82-31-776-1140~3 www.sinsin.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

arexarex

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130685522000044GTIN-13: 0685522000044
EAN-13: 0685522000044
GTIN-12: 685522000044
UPC-A: 685522000044
GTIN storage (14 digits): 00685522000044
4096907a-2328-071f-e063-6394a90a7e17.jpg, AREX MEDIUM.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-020-10AREX SINSIN PAS10 in 1 POUCHPATCH1010
55264-020-10AREX SINSIN PAS1 in 1 CARTONPATCH110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET2
LEVOMENTHOLACTIVE INGREDIENTBZ1R15MTK72
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y2
PEPPERMINT OILACTIVE INGREDIENTAV092KU4JH2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET2
LEVOMENTHOLACTIVE MOIETYBZ1R15MTK72
PEPPERMINTACTIVE MOIETYV95R5KMY2B2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2
BENZYL NICOTINAMIDEINACTIVE INGREDIENTHF1W0213QP2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
NATURAL LATEX RUBBERINACTIVE INGREDIENT2LQ0UUW8IN2
NONIVAMIDEINACTIVE INGREDIENTS846B891OR2
POLYBUTENE (1400 MW)INACTIVE INGREDIENT1NA5AO9GH72
POLYISOBUTYLENE (200000 MW)INACTIVE INGREDIENTZ6Y02I05912
ROSININACTIVE INGREDIENT88S87KL8772

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55264-02055264-020-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-01-07full-release2026-06-01 00:51:04

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 170 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii candidate
90 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii+route
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route
34 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKFILM, SOLUBLE / ORAL14 mgExact identifier — unii candidate
90 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii+route
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii+route
34 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOAP / TOPICAL0.02 %w/wExact identifier — unii+route
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route
34 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKFILM, SOLUBLE / ORAL14 mgExact identifier — unii candidate
90 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / RESPIRATORY (INHALATION)4.02 %w/vExact identifier — unii candidate
90 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE / ORAL349.9 mgExact identifier — unii candidate
90 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
90 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSHAMPOO / TOPICAL0.1 %w/wExact identifier — unii+route
24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL / TOPICAL8 mgExact identifier — unii+route
24 equally ranked IID candidates
POLYBUTENE (1400 MW)POLYBUTENE (1400 MW)1NA5AO9GH7FILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii+route
4 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, FILM COATED / ORAL300 mgExact identifier — unii candidate
90 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route
34 equally ranked IID candidates
ROSINROSIN88S87KL877TABLET, EXTENDED RELEASE / ORAL8.99 mgExact identifier — unii candidate
18 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / AURICULAR (OTIC)0.38 %w/wExact identifier — unii candidate
90 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii+route
34 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKGUM, CHEWING / BUCCAL3492 mgExact identifier — unii candidate
90 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKPOWDER, DENTIFRICE / DENTAL0.5 mg/mgExact identifier — unii candidate
90 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, DELAYED RELEASE / ORAL8.4 mgExact identifier — unii candidate
90 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / RESPIRATORY (INHALATION)4.02 %w/vExact identifier — unii candidate
90 equally ranked IID candidates
ROSINROSIN88S87KL877TABLET, COATED / ORAL10 mgExact identifier — unii candidate
18 equally ranked IID candidates
ROSINROSIN88S87KL877CAPSULE / ORALNAExact identifier — unii candidate
18 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, FILM COATED / ORAL300 mgExact identifier — unii candidate
90 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii+route
34 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, EXTENDED RELEASE / ORAL229.7 mgExact identifier — unii candidate
90 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KLOTION / TOPICAL1000 mgExact identifier — unii+route
24 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE, DELAYED RELEASE / ORAL20 mgExact identifier — unii candidate
90 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii+route
34 equally ranked IID candidates
ROSINROSIN88S87KL877TABLET, COATED / ORAL10 mgExact identifier — unii candidate
18 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii+route
24 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSWAB / TOPICAL0.5 %w/wExact identifier — unii+route
24 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE / ORAL349.9 mgExact identifier — unii candidate
90 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKGUM, CHEWING / BUCCAL3492 mgExact identifier — unii candidate
90 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route
34 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL, METERED / TOPICAL4 mgExact identifier — unii+route
24 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET / ORAL793 mgExact identifier — unii candidate
90 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KAEROSOL, FOAM / TOPICAL4 mgExact identifier — unii+route
24 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE / ORAL349.9 mgExact identifier — unii candidate
90 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route
34 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE, DELAYED RELEASE / ORAL20 mgExact identifier — unii candidate
90 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii+route
34 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKGUM, CHEWING / BUCCAL3492 mgExact identifier — unii candidate
90 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / AURICULAR (OTIC)0.38 %w/wExact identifier — unii candidate
90 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+route
34 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / INTRAVENOUS4.02 %w/vExact identifier — unii candidate
90 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE, DELAYED RELEASE / ORAL20 mgExact identifier — unii candidate
90 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii candidate
90 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / AURICULAR (OTIC)0.38 %w/wExact identifier — unii candidate
90 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKGUM, CHEWING / BUCCAL3492 mgExact identifier — unii candidate
90 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
90 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / RESPIRATORY (INHALATION)4.02 %w/vExact identifier — unii candidate
90 equally ranked IID candidates
ROSINROSIN88S87KL877CAPSULE / ORALNAExact identifier — unii candidate
18 equally ranked IID candidates

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
AREX SINSIN PASCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.2013ea44-e2ea-4b36-bddb-7f64163284b62025-10-07WarningsExact identifier
ndc (package): 55264-020-10
ndc (product): 55264-020
ndc11 (package): 55264002010
spl id: 409672cd-3303-b2e0-e063-6294a90a3569
spl set id: 2013ea44-e2ea-4b36-bddb-7f64163284b6

Reported adverse events (FAERS/openFDA)#

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