SINSINPAS AREX LOTION

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 00:06:47

Label at a glance#

ProductSINSINPAS AREXLOTION
Active ingredientMETHYL SALICYLATE, ALPHA-TOCOPHEROL ACETATE, LEVOMENTHOL
Label structure9 sections

Indications and uses

Temporarily relieves minor pain associated with: Arthritis Simple backache Muscle strains Sprains Bruises Cramps

Dosage and administration

Adults and children 12 years of age and over: apply a thin layer to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but no more than 3 to 4 times daily AFTER APPLYING, WASH HANDS WITH SOAP AND WATER Children undress 12 years of age: ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 200.0mg

L-Menthol 60.0mg

Tocopherol Acetate 1.0mg

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with:

  • Arthritis
  • Simple backache
  • Muscle strains
  • Sprains
  • Bruises
  • Cramps

Warnings

WARNINGS SECTION

For external use only

allergy alert: If prone to allergic reaction from aspirin or salicylates or allergic to any ingredients in this product, consult a doctor before use.

When using this product

  • use only as directed
  • avoid contact with eyes and mucous membranes or rashes
  • rare cases of serious burns have been reported with products of this type
  • do not apply to wounds or damaged, broken irritated skin
  • do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
  • do not use at the same time as other topical analgesics
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight
  • avoid applying into skin folds

stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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.

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:

  • apply a thin layer to affected area
  • massage into painful area until thoroughly absorbed into skin

repeat as necessary, but no more than 3 to 4 times daily

  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

Children undress 12 years of age: ask a doctor

Other Information

OTHER SAFETY INFORMATION

  • Avoid storing product in direct sunlight, store at 20-25C (68-77F)
  • Store with lid closed tightly

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Nonylic acid vanillyamide, Carbomer 941, Light liquid paraffin, Polysorbate 60, Sorbital Monostearate. Lanolin oil, Triethanolamine, Fresh yuja flavor, Purified water

SINSINPAS AREX LOTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SINSINPAS AREX LOTION BOTTLESINSINPAS AREX LOTION BOTTLESINSINPAS AREX LOTION BOXSINSINPAS AREX LOTION BOX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-112-01SINSINPAS AREXLOTION1 in 1 BOTTLELOTION12
55264-112-02SINSINPAS AREXLOTION1 in 1 BOXLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-112SINSINPAS AREXLOTION (L-MENTHOL) LOTION [SINSIN PHARMACEUTICAL CO., LTD.]2Legacy NDC, 2 package rows20240106_ca93de41-1aa7-7996-e053-2995a90afe6b.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55264-11255264-112-01, 55264-112-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
0e3cb18b-0253-3807-e063-6394a90a3793ca93de41-1aa7-7996-e053-2995a90afe6b2024-01-05WarningsExact identifier
spl id: 0e3cb18b-0253-3807-e063-6394a90a3793
spl set id: ca93de41-1aa7-7996-e053-2995a90afe6b

Reported adverse events (FAERS/openFDA)#

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