Label: SINSINPAS COLD- l-menthol patch

  • NDC Code(s): 55264-104-01, 55264-104-02
  • Packager: Sinsin Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 5, 2024

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

  • Active Ingredients

    L-Menthol (5%)

  • Purpose

    Topical Analgesic

  • 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.

  • 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

    When using this product

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

    Ask a doctor before use if you are prone to allergic reaction from aspirin or salicylates

    Stop use and ask a doctor if

    • 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

    If pregnant or breast-feeding, ask a health professional before use.

  • 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

  • Inactive Ingredients

    Aloe vera gel, BHT, Castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydoxide gel, gelatin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methyl paraben, PEG monostearte, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate.

  • SINSINPAS COLD PATCH

    SINSINPAS COLD PATCH LABEL

  • INGREDIENTS AND APPEARANCE
    SINSINPAS COLD 
    l-menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.85 g  in 17 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    POVIDONE (UNII: FZ989GH94E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SILODRATE (UNII: 9T3UU8T0QK)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-104-024 in 1 POUCH08/01/2018
    1NDC:55264-104-0117 g in 1 PATCH; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/01/2018
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-104)