Label: MEDICATED PAIN - camphor (synthetic), levomenthol and methyl salicylate patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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  • ACTIVE INGREDIENT

    Active ingredients
    dl-Camphor 0.5%
    l-Menthol 0.4%
    Methyl Salicylate 0.8%

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  • PURPOSE

    Purpose
    dl-Camphor    External analgesic
    l-Menthol        External analgesic
    Methyl Salicylate      External analgesic

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  • INDICATIONS & USAGE

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

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  • WARNINGS

    Warnings
    For external use only

    Do not use
    ■ on wounds or on damaged skin

    When using this product
    ■ avoid contact with the eyes
    ■ do not bandage tightly

    Stop use and ask a doctor if
    ■ condition worsens
    ■ symptoms persist for more than 7 days
    ■ 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.

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  • DOSAGE & ADMINISTRATION

    Directions
    ■ Strip off the polyethylene film and place adhesive pad over affected area.
    ■ Change pad 1 or 2 times a day
    ■ Not for children under 4 years.

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  • INACTIVE INGREDIENT

    Inactive ingredients
    aluminum hydroxide gel, carbomer, carmellose sodium, edetate disodium, glycerin, malic acid, methacrylic acid and n-butyl acrylate copolymer, partially hydrolyzed polyvinyl alcohol, partially neutralized polyacrylate, PEG 60 hydrogenated castor oil, sorbitol, titanium dioxide, water.

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  • PRINCIPAL DISPLAY PANEL

    CVSpainpadscart.jpg
    Carton
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  • PRINCIPAL DISPLAY PANEL

    CVSpainpadsPDP.jpg
    PDP


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  • INGREDIENTS AND APPEARANCE
    MEDICATED PAIN  
    dl-camphor, l-menthol, methyl salicylate patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-606
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 5 mg
    LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL 4 mg
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 8 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE SODIUM  
    POLYVINYL ALCOHOL  
    SORBITOL  
    GLYCERIN  
    TITANIUM DIOXIDE  
    EDETATE DISODIUM  
    ALGELDRATE  
    MALIC ACID  
    WATER  
    POLYOXYL 60 HYDROGENATED CASTOR OIL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-606-01 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 11/02/2001
    Labeler - CVS Pharmacy (062312574)
    Registrant - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    Name Address ID/FEI Business Operations
    Sato Pharmaceutical Co., Ltd. 715699133 manufacture(59779-606)
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