Label: SINSINPAS AREXGEL- l-menthol patch

  • NDC Code(s): 55264-114-01, 55264-114-02
  • Packager: Sinsin Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 27, 2021

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

  • Uses

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

    • Arthritis
    • Simple backache
    • Strains
    • Bruises
    • Sprains
  • Warnings

    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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 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

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

    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

    SINSINPAS AREX GEL PATCH

  • INGREDIENTS AND APPEARANCE
    SINSINPAS AREXGEL 
    l-menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)96 mg
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL76.8 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE57.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    NONIVAMIDE (UNII: S846B891OR)  
    SORBITOL (UNII: 506T60A25R)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    WATER (UNII: 059QF0KO0R)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-114-021 in 1 POUCH08/27/2021
    1NDC:55264-114-016 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/27/2021
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-114)