Label: SINSINPAP HOT- dl-camphor, mentha oil, eucalyptus oil patch

  • NDC Code(s): 55264-103-01, 55264-103-02
  • 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 December 20, 2019

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

  • Active ingredients

    Dl- camphor 82.4mg

    Mentha oil 164.7mg

    Eucalyptus oil 16.5mg

  • 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 eyes and mucous membranes • do not apply to wounds or damaged skin

    Stop use and ask a doctor if :

    • condition worsens • symptoms persist 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 older : apply to affected area not more than 3 to 4 times daily.
    • Children under 12 years of age : do not use, consult with 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 .

  • Inactive ingredients

    Butylhydroxytoluene, Carboxymethylcellulose sodium, Castor oil, Concentrated glycerin, Disodium edetate hydrate, Gelatin, Isopropyl myristate, Kaolin, Magnesium aluminometasilicate, Methylparaben, Polyethyleneglycol monostearate, Polysorbate80, Polyvinyl alcohol, Purified water, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Vanillyl nonylamide

  • SINSINPAP HOT

    sinsinpap hot

  • INGREDIENTS AND APPEARANCE
    SINSINPAP HOT 
    dl-camphor, mentha oil, eucalyptus oil patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL16.5 mg  in 17.5 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)82.4 mg  in 17.5 g
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL164.7 mg  in 17.5 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    NONIVAMIDE (UNII: S846B891OR)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    KAOLIN (UNII: 24H4NWX5CO)  
    SILODRATE (UNII: 9T3UU8T0QK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GELATIN (UNII: 2G86QN327L)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-103-025 in 1 POUCH02/13/2018
    1NDC:55264-103-0117.5 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/13/2018
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-103)