Label: SATOHAP- camphor, menthol, methyl salicylate lotion

  • NDC Code(s): 49873-620-01
  • 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

    Camphor

    Menthol

    Methyl salicylate

  • PURPOSE

    Purpose

    Camphor   External analgesic

    Menthol   External analgesic

    Methyl salicylate   External analgesic

  • INDICATIONS & USAGE

    Uses  Temporarily relieves minor aches and pains of muscles and joints due to:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings

    For external use only

    Flammable: Keep away from fire or flame

    Do not use

    • on wounds
    • on irritated, broken, or damaged skin
    • otherwise than as directed

    When using this product

    • avoid contact with the eyes or mucous membranes
    • do not bandage 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

    • adults and children 3 years of age and older: apply to the affected area not more than 3 to 4 times daily
    • children under 3 years of age:  consult your physician
    • refer to the above warnings; use otherwise than as directed may be dangersous
  • OTHER SAFETY INFORMATION

    Other information

    • keep container tightly closed
    • store at room temperature (20° to 25° C or 68° to 77° F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    alcohol, propylene glycol, water.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    SATOHAP 
    camphor, menthol, methyl salicylate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-620
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 g  in 100 mL
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL6 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-620-011 in 1 CARTON01/10/2019
    145 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/10/2019
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-620) , pack(49873-620) , label(49873-620)