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KANKA (Blistex Inc.)

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GEL 1 APPLICATOR in 1 BLISTER PACK (10157-9493-1) > 2 g in 1 APPLICATOR Label Information

Complete KANKA Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredient Purpose
    Benzocaine 20.0% (w/w) Oral anesthetic/analgesic
    Zinc Chloride 0.1% (w/w) Oral astringent

  • Uses

    • for the temporary relief of pain due to toothaches, canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums

  • Warnings

    For oral use only

    Allergy alert

    do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

    When using this product

    do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

    Keep out of reach of children.

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


  • Directions

    • twist base clockwise to dispense. It may take up to 10 full turns to dispense the initial dose, but subsequent uses should require less than 1 turn.
    • to clean brush tip, rinse with cold water
    • adults and children 2 years of age and older: dry affected area and apply medication by gently brushing the affected area.
    • use up to 4 times daily or as directed by a dentist or doctor
    • children under 2 years of age: consult a dentist or doctor
    • children under 12 years of age should be supervised in the use of this product

  • Other information

    • do not purchase if package has been opened
    • store at 20-25°C (68-77°F)
    • replace cap after use to prevent drying
    • avoid contact with the eyes
    • this is a personal care item, and should be used by one individual only
    • with zinc chloride, some color may be evident; this is normal

  • Inactive ingredients

    butylparaben, ethylparaben, flavors, glycerin, methylparaben, PEG-8, PEG-75, propylparaben, silica, sucralose


  • PRINCIPAL DISPLAY PANEL - 2.0 g Package

    NDC 10157-9493-1

    Blistex®

    PROFESSIONAL STRENGTH

    KANKA®

    SoftBrush®

    Tooth & Gum Pain Gel

    ORAL ANESTHETIC / ORAL ASTRINGENT

    Maximum Pain Relief

    Dual Medications

    Gentle Application

    Easy Reach Design
    Ultra Soft Tip
    50+ Uses

    Toothaches

    Brace/Denture Irritation

    Gum Discomfort

    Canker Sores

    NET WT.
    0.07 OZ (2.0 g)

    Principal Display Panel - 2.0 g Package

  • INGREDIENTS AND APPEARANCE
    KANKA   SOFTBRUSH
    benzocaine and zinc chloride gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-9493
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 20 mL  in 100 g
    Zinc Chloride (UNII: 86Q357L16B) (Zinc - UNII:J41CSQ7QDS) Zinc Chloride 0.1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    glycerin (UNII: PDC6A3C0OX)  
    methylparaben (UNII: A2I8C7HI9T)  
    polyethylene glycol 400 (UNII: B697894SGQ)  
    polyethylene glycol 3350 (UNII: G2M7P15E5P)  
    propylparaben (UNII: Z8IX2SC1OH)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10157-9493-1 1 in 1 BLISTER PACK
    1 2 g in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 05/01/2009
    Labeler - Blistex Inc. (005126354)
    Establishment
    Name Address ID/FEI Business Operations
    Blistex Inc. 005126354 MANUFACTURE