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

  • NDC Code(s): 49873-068-02
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • ACTIVE INGREDIENT

    Active ingredients
    dl-Camphor 5%
    l-Menthol 4%
    Methyl salicylate 10%

  • 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 due to
    ■ backache   ■ arthritis   ■ strains   ■ bruises   ■sprains

  • 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

    ■ symptoms persist for more than 7 days

    ■ symptoms clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Warnings-contents under pressure

    ■ do not puncture or incinerate container.

    ■ do not expose to heat or store at temperatures above 120 degrees F.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ adults and children 2 years of age and over: Hold can upright and spray until wet. Apply to affected area not more than 3 to 4 times daily.
    ■ children under 2 years of age: Do not use and ask a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients
    fragrance, phenylethyl alcohol, alcohol, propylene glycol, LPG

  • PRINCIPAL DISPLAY PANEL

    carton

  • INGREDIENTS AND APPEARANCE
    SATOHAP 
    methyl salicylate, dl-camphor, l-menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-068
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 mL
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL4 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ALCOHOL (UNII: 3K9958V90M)  
    LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-068-0270 mL in 1 CANISTER; Type 0: Not a Combination Product11/03/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/03/2006
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Daizo Corporation695312298pack(49873-068) , label(49873-068)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-068)
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