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
  • 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 31, 2020

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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 not finalpart34811/08/1989
    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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