Label: SINSINPAS AREX FLEX GEL PAIN RELIEVING PATCH- l-menthol patch

  • NDC Code(s): 55264-116-01, 55264-116-02
  • Packager: Sinsin Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 1, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredients

    L-Menthol 76.8mg

    Methyl Salicylate 57.6mg

    DL-Camphor 96.0mg

  • Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

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

    • Arthritis
    • Simple backache
    • Strains
    • Bruises
    • Sprains
  • WARNINGS

    For external use only

    Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.


    Do not use

    • on wounds or damaged skin
    • if you are allergic to any ingredients of this product
    • with a heating pad

    When using this product

    • use only as directed
    • avoid contact with eyes, mucous membranes, and rashes

    Stop use and ask a doctor if

    • skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
    • 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 or reach of children

    Keep out of reach of children.

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

  • Directions

    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 times daily
    ■ remove patch from skin after at most 8 hours of application

    children under 12 years of age: Consult a doctor

  • Other Information

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

  • Inactive Ingredients

    Butylated hydroxytoluene, Methylparaben, Polysorbate 80, Castor Oil, D-Sorbitol Solution,
    Concentrated Glycerin, Dihydroxyaluminum, Aminoacetate, Disodium Edetate Hydrate, Carboxymethylcellulose sodium, Kaolin, Titanium Dioxide, Sodium Polyacrylate, Aloe Vera Gel, Gelatin, Nikasol TS-620, Tartaric Acid, Nonylic acid vanillyamide, Purified Water

  • PRINCIPAL DISPLAY PANEL

    Sinsinpas Arex Flex Gel Patch

  • INGREDIENTS AND APPEARANCE
    SINSINPAS AREX FLEX GEL PAIN RELIEVING PATCH 
    l-menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE57.6 mg
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)96 mg
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL76.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TARTARIC ACID (UNII: W4888I119H)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    GELATIN (UNII: 2G86QN327L)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    NONIVAMIDE (UNII: S846B891OR)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-116-021 in 1 POUCH05/01/2024
    1NDC:55264-116-016 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/01/2024
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-116)