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Canker Complete (Wasatch Product Development)

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CREAM 1 TUBE in 1 BOX (44717-890-02) > 6 g in 1 TUBE (44717-890-01) Label Information

Complete Canker Complete Information

  • ACTIVE INGREDIENT

    Active ingredient                              Purpose 

    Menthol 0.5%                                  Oral Pain Reliever               

    Uses        For the temporary relief of pain associated with canker and mouth sores

    Keep this and all drugs out of reach of children

    Stop use and ask a dentist or physician if

    - Sore mouth symptoms do not improve in 7 days

    - Irritation, pain or redness worsens

    - Swelling, rash or fever develops

    Do not use this product for more than 7 days unless directed by a health professional

    Directions

    Adults and children 2 years and older              Gently dab medication on the site of irritation with a cotton swab or fingertip

                                                                       Apply to the affected area up to 4 times a day, or as directed by a dentist or physician


    Children under 12 years                               Adult supervision should be given in the use of this product

    Children under 2 years                                 Consult dentist or physician

    Inactive ingredients:

    Calcium/Sodium PVM/MA Copolymer, TX-Factor 5 tm (propietary polypeptide lipid blend), Cellulose Gum, Mineral Oil,  Petrolatum, Lecithin, Chlorella Vulgaris  Extract, Hydrolyzed Lupine Protein, Silica, C12-15 Alkyl  Benzoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Tetrasodium EDTA, Flavor, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Caprylyl Glycol, Stearyl Glycyrrhetinate, Sucralose, DC Red Lake 27

    image of secondary label


  • PRINCIPAL DISPLAY PANEL

    Canker Complete   Net wt. .21oz (6g)

    image of Primary label


  • INGREDIENTS AND APPEARANCE
    CANKER COMPLETE  CANKER SORE RELIEF
    menthol cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:44717-890
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:44717-890-02 1 in 1 BOX 10/12/2010
    1 NDC:44717-890-01 6 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/12/2010
    Labeler - Wasatch Product Development (962452533)
    Registrant - Wasatch Product Development (962452533)
    Establishment
    Name Address ID/FEI Business Operations
    Wasatch Product Development 962452533 manufacture(44717-890)