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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 ingredients 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

    METHEMOGLOBINEMIA WARNING

    Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if you or a child in your care develops:

    • pale, gray, or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

    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 this product 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 more than used for pain is accidentally 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 12 years of age should be supervised in the use of this product
    • children under 2 years of age: consult a dentist or doctor

  • Other information

    • do not purchase if package has been opened
    • 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 Applicator Blister Pack

    Blistex®

    MAXIMUM STRENGTH

    KANKA®

    SoftBrush®

    Tooth & Gum Pain Gel

    ORAL ANESTHETIC/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 Applicator Blister Pack

  • 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 g  in 100 g
    Zinc Chloride (UNII: 86Q357L16B) (Zinc cation - UNII:13S1S8SF37) Zinc cation 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 05/01/2009
    1 2 g in 1 APPLICATOR; Type 0: Not a Combination Product
    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(10157-9493)