Label: SATOHAP COOL AND HOT- camphor, capsaicin, menthol patch

  • NDC Code(s): 49873-622-01
  • Packager: Sato Pharmaceuticals Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 1, 2024

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  • Active ingredients

    Camphor 3.1%

    Capsaicin 0.025%

    Menthol 6%

  • Purpose

    External analgesic

    External analgesic

    External analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints due to:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    Do not use

    • on irritated or damaged skin
    • on wounds

    Ask a doctor or pharmacist before use if you have

    • any concerns about using this product

    When using this product

    • avoid contact with the eyes or mucus membranes
    • do not bandage tightly
    • do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases 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
    • you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)

    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

    Report any unexpected side effects from the use of this product to the FDA MedWatch Program

    Keep out of reach of children.

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

  • Directions

    • Adults and children 4 years of age and older: remove polyethylene film and place adhesive pad over affected area.
    • Do not use more than 2 patches per day.
    • Children under 4 years of age: Consult a doctor.
  • Other information

    • keep pouch tightly closed
    • keep product protected from heat
  • Inactive ingredients

    carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, dried aluminum hydroxide gel, edetate disodium, emulsion of methyl acrylate and 2-ethylhexyl acrylate copolymer, glycerin, malic acid, partially neutralized polyacrylate, polysorbate 80, polyvinyl alcohol, sorbitol solution, talc, titanium dioxide, and water on a polyester fiber backing and covered with a polyethylene film.

  • SATOHAP COOL & HOT 10cm BY 7cm

    SATOHAP COOL & HOT 10cm BY 7CM

  • INGREDIENTS AND APPEARANCE
    SATOHAP COOL AND HOT 
    camphor, capsaicin, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-622
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.1 g  in 100 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    MALIC ACID (UNII: 817L1N4CKP)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    TALC (UNII: 7SEV7J4R1U)  
    ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-622-011 in 1 BOX09/01/2024
    15 in 1 POUCH
    16.3 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/01/2024
    Labeler - Sato Pharmaceuticals Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceuticals Co., Ltd.715699133manufacture(49873-622) , pack(49873-622) , label(49873-622)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fuji Seal, Inc.718023935label(49873-622) , pack(49873-622)
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