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

  • NDC Code(s): 49873-065-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

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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

    temporarily relieves minor aches and pains of muscles and joints due to
    ■ backache     ■ arthritis     ■ strains     ■ bruises     ■ sprains

  • WARNINGS

    Warnings
    For external use only

    Do not use

    ■ on wounds

    ■ on damaged or irritated skin


    When using this product

    ■ avoid contact with the eyes and mucous membranes

    ■ do not bandage tightly

    Stop use and ask a doctor if

    ■ excessive irritation develops

    ■ condition worsens

    ■ symptoms persist for more than 7 days

    ■ symptoms clear up and occur again within a few days

    ■ when using for pain of arthritis if:

    ■ pain persist for more than 10 days

    ■ redness is present

    ■ in conditions affecting children under 12 years of age


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

  • DOSAGE & ADMINISTRATION

    Directions
    ■ adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily.
    ■ children under 2 years of age: do not use, ask a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients
    edetate disodium, alcohol, propylene glycol, water

  • PRINCIPAL DISPLAY PANEL

    Satohap Lotion Carton

  • INGREDIENTS AND APPEARANCE
    SATOHAP 
    methyl salicylate, dl-camphor, l-menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-065
    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
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 g  in 100 mL
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-065-011 in 1 CARTON02/05/1991
    145 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/05/1991
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-065) , label(49873-065) , pack(49873-065)
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