Label: SINSINPAP COOL- levomenthol, thymol, camphor, mentha, eucalyptus patch

  • NDC Code(s): 55264-012-04, 55264-012-05
  • 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 February 27, 2023

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  • Active ingredients

    L-Menthol 49.4 mg

    Thymol 16.5 mg

    DL-Camphor 82.4 mg

    Mentha Oil 164.7 mg

    Eucalyptus Oil 16.5 mg

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves minor pain associated with

    • muscular pain
    • joint pain
    • backache
    • bruise
    • sprain
  • Warnings

    For external use only

  • When using this product:

    • use only as directed
    • do not bandage tightly or use with a healing pad
    • avoid contact with the eyes and mucous membranes
    • do not apply to wounds or damaged skin
  • Stop use and ask a doctor if

    • conditions worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • skin irritation develops
  • Keep out of reach of children.

    If swallowed, get medical help from hospital right away

  • Directions

    • Adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily.
    • Children under 12 years of age: do not use, consult a doctor
    • For easy application: partially peel back protective film and apply exposed patch to the site of pain.
    • Carefully remove remaining film while pressing patch to skin for secure adhesion.
  • Storage condition

    • avoid storing product in direct sunlight
    • store at room temperature
  • Inactive ingredients

    BHT, Castor oil, Concentrated Glycerin, Disodium edetate hydrate, D-sorbitol, Isopropyl myristate, Kaolin, Magnesium aluminometasilicate, Methyl Paraben, PEG-4 stearate, Polysorbate 80, Titanium dioxide, Carboxymethylcellulose Sodium, Sodium Polyacrylate, Polyvinyl alchol, Gelatin, Tataric acid, Purified water

  • Manufactured by:

    SINSIN PHARM. CO., LTD.

    Distributed by SS Pharmed USA

    Made in Korea

    NDC # : 55264-012-01

  • Principal Display Panel

    Sinsin Pap Cool

  • INGREDIENTS AND APPEARANCE
    SINSINPAP COOL 
    levomenthol, thymol, camphor, mentha, eucalyptus patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-012
    Route of AdministrationTOPICAL, CUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL49.4 mg
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL16.5 mg
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)82.4 mg
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL164.7 mg
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL16.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SORBITOL (UNII: 506T60A25R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    KAOLIN (UNII: 24H4NWX5CO)  
    SILODRATE (UNII: 9T3UU8T0QK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-4 STEARATE (UNII: J33E8608YN)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-012-051 in 1 CARTON05/30/2016
    1NDC:55264-012-045 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/30/2016
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-012)
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