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Satogesic Hot (Sato Pharmaceutical Co., Ltd.)

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PATCH 1 POUCH in 1 CARTON (49873-608-01) > 5 PATCH in 1 POUCH Label Information

Complete Satogesic Hot Information

  • ACTIVE INGREDIENT

    Active ingredient    
    Capsicum extract 0.04% (Containing Capsaicin 0.025%)


  • PURPOSE

    Purpose
    Capsaicin    External analgesic


  • INDICATIONS & USAGE

    Uses  temporary relieves minor aches and pains of muscles and joints associated with
    â–  simple backache    â–  arthritis    â–  strains    â–  bruises    â–  sprains


  • WARNINGS

    Warnings
    For external use only

    Do not use
    â–  on wounds, or on damaged, or irritated skin
    â–  on children under 12 years with arthritis-like conditions unless directed by a doctor

    When using this product
    â–  avoid contact with eyes or mucous membranes  â–  do not cover with any additional wrap

    Stop use and ask a doctor if
    â–  rash, itching or excessive irritation develops  â–  redness occurs  â–  condition worsens
    â–  symptoms persist for more than 7 days  â–  symptoms clear up and occur again withn a few days

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.


  • DOSAGE & ADMINISTRATION

    Directions
    â–  Adults and children 2 years of age and over:
        â–  strip off the polyethylene film and place adhesive pad over affected area
        â–  pad may be cut with scissors for small areas such as fingers
        â–  change pad 1 or 2 times a day
        â–  apply to affected area not more than 3 or 4 times daily
    â–  Children under 2 years of age: do not use, consult a doctor

  • OTHER SAFETY INFORMATION

    Other information
    â–  store unused pads in the pouch  â–  reseal the pouch after opening and keep tightly closed


  • INACTIVE INGREDIENT

    Inactive ingredients
    Butylparaben, carbomer, carboxymethylcellulose sodium, dried aluminum hydroxide gel, edetate disodium, glycerin, malic acid, methacrylic acid and n-butyl acrylate copolymer, methylparaben, partially neutralized polyacrylate, polyethylene glycol 3000 hydrogenated castor oil, polyvinyl alcohol, purified water, sorbitol, titanium dioxide


  • PRINCIPAL DISPLAY PANEL

    SatogesicHotGelPadscartA.jpg
    Carton, Part A





  • PRINCIPAL DISPLAY PANEL

    SatogesicHotGelPadscartB.jpg
    Carton, Part B



  • PRINCIPAL DISPLAY PANEL

    SatogesicHotGelPadsPDP.jpg
    PDP

  • INGREDIENTS AND APPEARANCE
    SATOGESIC HOT 
    capsaicin patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-608
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALGELDRATE (UNII: 03J11K103C)  
    MALIC ACID (UNII: 817L1N4CKP)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49873-608-01 1 in 1 CARTON
    1 5 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 11/22/2006
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    Name Address ID/FEI Business Operations
    Sato Pharmaceutical Co., Ltd. 715699133 manufacture, label, pack