Label: SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM- camphor, menthol, methyl salicylate patch

  • 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 June 20, 2011

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  • Active ingredient

    • DL-Camphor 1.20 %
    • L-Menthol 5.70 %
    • Methyl Salicylate 6.30 %
  • Purpose

    Topical Analgesic

  • Uses

    for temporary relief of minor pain associated with:

    • arthritis
    • simple backache
    • tendonitis
    • muscle strains
    • bruises
  • Warnings

    • For external use only
    • If pregnant or breast feeding, consult a healthcare professional.
    • Allergy Alert: If you are allergic to any ingredients of this product, ask a doctor before use.

    When using this product

    • use only as directed
    • do not bandage tightly or use with heating pad
    • avoid contact with eyes and mucous membranes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist more than 7 days or clear up and occur again within a few days
    • rash, itching, excessive skin irritation develops.

    Keep out of reach of children.

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

  • Directions

    • Adults and children 12 years of age and older
    • clean and dry affected
    • remove patch from film
    • apply to affected area not more than 3 to 4 times daily for 7 days
    • Children under 12 years of age consult a doctor
  • Other information

    • avoid storing product in direct sunlight
    • protect product from excessive moisture.
  • Inactive ingredients

    Butylated Hydroxy Toluene, Dihydroxy Aluminum Amino Acetate, Disodium Edetate, Gelatin, Glycerin, Kaolin, Magenesium Aluminometasilicate, Methyl Paraben, Polysorbate 80, Polyvinyl Alcohol, Purified Water, Sodium Polyacrylate, Sorbitan Sesquioleate, Tartaric Acid, Titanium Dioxide

  • Questions or Comments?

    Distributed by

    M J Winston International, Ltd.

    San Dimas, California 91773

    www.smartmed.us

    Made in Korea

  • Package/Label Principal Display Panel

    SMART PRO PATCH

    WellPatch Pain Relief Patch
  • INGREDIENTS AND APPEARANCE
    SMART PRO  MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM
    camphor, menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76092-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.2 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.7 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE6.3 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ALMASILATE (UNII: OZQ8O62H53)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76092-101-055 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2011
    Labeler - M J Winston International Ltd.. (144927378)
    Registrant - M J Winston International Ltd. (144927378)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture
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