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

  • NDC Code(s): 49873-621-01
  • 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 January 1, 2021

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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 persists for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive irritation of the skin developes
    • nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs.
    • you feel actual pain or experience a blistering or burning after application (it is normal to feel awarming or cooling sensation)
    • when using for pain or 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.

  • Questions or comments?

    • contact Sato Pharmaceutical Inc. 20695 S. Western Ave., Suite 240, Torrence, CA 90501
    • you may also report serious side effects to this address
  • Satohap Cool and Hot Pads

    Satohap Cool and Hot Pads

  • INGREDIENTS AND APPEARANCE
    SATOHAP COOL AND HOT PADS 
    camphor, capsaicin, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-621
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.04 g  in 100 mL
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL6 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    WATER (UNII: 059QF0KO0R)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TALC (UNII: 7SEV7J4R1U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MALIC ACID (UNII: 817L1N4CKP)  
    TRIETHYLENE GLYCOLDIMETHACRYLATE (UNII: 14I47YJ5EY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-621-011 in 1 BOX12/18/2020
    15 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/18/2020
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-621) , pack(49873-621) , label(49873-621)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fuji Seal, Inc.718023935pack(49873-621) , label(49873-621)
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