Label: SATOHAP- dl-camphor, l-menthol, methyl salicylate patch

  • NDC Code(s): 49873-018-02, 49873-018-05
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 10, 2023

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  • ACTIVE INGREDIENT

    Active ingredients
    dl-Camphor 0.5%
    l-Menthol 0.4%
    Methyl Salicylate 0.8%

  • PURPOSE

    Purpose
    dl-Camphor    External analgesic
    l-Menthol        External analgesic
    Methyl Salicylate      External analgesic

  • INDICATIONS & USAGE

    Uses  temporary relieves minor aches and pains of muscles and joints associated with
    ■ simple backache    ■ arthritis    ■ strains    ■ bruises    ■ sprains

  • WARNINGS

    Warnings
    For external use only

    Do not use

    ■ on wounds or on damaged skin

    When using this product

    ■ avoid contact with the eyes

    ■ do not bandage tightly

    Stop use and ask a doctor if

    ■ condition worsens

    ■ symptoms persist for more than 7 days

    ■ symptoms clear up and occur again withn a few days


    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


  • DOSAGE & ADMINISTRATION

    Directions
    ■ Strip off the polyethylene film and place adhesive pad over affected area.
    ■ Change pad 1 or 2 times a day
    ■ Not for children under 4 years.

  • INACTIVE INGREDIENT

    Inactive ingredients
    aluminum hydroxide gel, carbomer, carmellose sodium, edetate disodium, glycerin, malic acid, methacrylic acid and n-butyl acrylate copolymer, partially hydrolyzed polyvinyl alcohol, partially neutralized polyacrylate, PEG 60 hydrogenated castor oil, sorbitol, titanium dioxide, water.

  • PRINCIPAL DISPLAY PANEL

    -05 Carton

  • PRINCIPAL DISPLAY PANEL

    -02 Carton


  • INGREDIENTS AND APPEARANCE
    SATOHAP 
    dl-camphor, l-menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 mg
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL4 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE8 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALGELDRATE (UNII: 03J11K103C)  
    MALIC ACID (UNII: 817L1N4CKP)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    BUTYL ACRYLATE/METHACRYLIC ACID COPOLYMER (2% METHACRYLIC ACID) (UNII: Q984S31CYH)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-018-051 in 1 CARTON11/08/1989
    15 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:49873-018-021 in 1 CARTON11/08/1989
    25 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/08/1989
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133label(49873-018) , pack(49873-018) , manufacture(49873-018)
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