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

  • NDC Code(s): 49873-060-01, 49873-060-02
  • 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 irritated, broken, or damaged skin    ■ on wounds    ■ otherwise than as directed

    When using this product

    ■ avoid contact with the eyes or mucous membranes ■ do not bandage the area

    tightly and do not apply local heat (heating pads, lamps, hot water in bags or bottles)

    because doing so can increase the risk of serious burns

    Stop use and ask a doctor if

    ■ condition worsens ■ symptoms persist for more than 7 days ■ symptoms clear up

    and occur again within a few days

    ■ excessive irritation of the skin develops ■ nausea, vomiting,

    abdominal discomfort, diarrhea, or skin rash occurs

    ■ when using for pain of arthritis:

    ■ pain persists for more than 10 days ■ redness is present ■ in conditions

    affecting children under 12 years of age

    ■ you experience pain, swelling, or blistering of the skin (this product should not cause

    pain or skin damage)

    Warning - Rare cases of serious burns have been reported to occur on the skin where

    OTC external analgesics were applied. Read and follow all directions and warnings on

    this label.

    Keep out of reach of children to avoid accidental poisoning. 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.

  • STORAGE AND HANDLING

    Other Information
    ■ keep pouch tightly closed until ready to use   ■ store at room temperature (20° to 25°C or 68° to 77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    carbomer 940, carboxymethylcellulose sodium, dried aluminum hydroxide gel, 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

    Carton

  • INGREDIENTS AND APPEARANCE
    SATOGESIC 
    dl-camphor, l-menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-060
    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
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MALIC ACID (UNII: 817L1N4CKP)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    ALGELDRATE (UNII: 03J11K103C)  
    BUTYL ACRYLATE/METHACRYLIC ACID COPOLYMER (2% METHACRYLIC ACID) (UNII: Q984S31CYH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-060-011 in 1 CARTON12/03/1990
    15 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:49873-060-021 in 1 CARTON12/03/1990
    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 finalpart34812/03/1990
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-060) , label(49873-060) , pack(49873-060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fuji Seal, Inc.718023935pack(49873-060) , label(49873-060)