FDA.reportPublic FDA data

SINSINPAS AREX INSTANT PAIN RELIEF SMALL

Manufacturer
Sinsin Pharmaceutical Co., Ltd.
Effective date
2024-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:46

Label at a glance#

ProductSINSINPAS AREX INSTANT PAIN RELIEF SMALL
Active ingredientCAMPHOR (SYNTHETIC), PEPPERMINT OIL, LEVOMENTHOL, METHYL SALICYLATE, ZINC OXIDE
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 34.10mg

L-Menthol 90.90mg

Mentha Oil 45.46mg

Methyl Salicylate 90.90mg

Zinc Oxide 431.82mg

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

Warnings

WARNINGS SECTION

For external use only

Do not use

  • 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 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

Keep out of reach of children

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

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

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.: 55264-021-06

Distributed by:

SPL UNCLASSIFIED SECTION

SINSIN PHARM AMERICA

Brea, CA 92821

www.sinsinpas.us

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SINSINPAS AREX SMALLSINSINPAS AREX SMALL

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-109-01SINSINPAS AREX INSTANT PAIN RELIEF SMALL1 in 1 POUCHPATCH12
55264-109-01SINSINPAS AREX INSTANT PAIN RELIEF SMALL10 in 1 PATCHPATCH102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-109SINSINPAS AREX INSTANT PAIN RELIEF SMALL (CAMPHOR, MENTHOL, MENTHA OIL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2Legacy NDC, 2 package rows20240106_c5ef616b-76c9-347f-e053-2a95a90a1dfa.zip

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
55264-10955264-109-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BENZYL NICOTINAMIDEHF1W0213QPIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CALCIUM CARBONATEH0G9379FGKIACT
GLYCERINPDC6A3C0OXIACT
ROSIN88S87KL877IACT
NATURAL LATEX RUBBER2LQ0UUW8INIACT
POLYISOBUTYLENE (200000 MW)Z6Y02I0591IACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
NONIVAMIDES846B891ORIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
PEPPERMINT OILAV092KU4JHACTIB
LEVOMENTHOLBZ1R15MTK7ACTIB
METHYL SALICYLATELAV5U5022YACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
0e3cb43a-d0eb-3728-e063-6394a90a619ac5ef616b-76c9-347f-e053-2a95a90a1dfa2024-01-05WarningsExact identifier
spl id: 0e3cb43a-d0eb-3728-e063-6394a90a619a
spl set id: c5ef616b-76c9-347f-e053-2a95a90a1dfa

Reported adverse events (FAERS/openFDA)#

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