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
  • 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 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 not finalpart34802/05/1991
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-065) , label(49873-065) , pack(49873-065)