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
  • 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 January 7, 2020

If you are a consumer or patient please visit this version.

  • 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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ALCOHOL (UNII: 3K9958V90M)  
    LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V)  
    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 not finalpart34811/03/2006
    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)