KANK-A MOUTH PAIN (BENZOCAINE) LIQUID [BLISTEX INC.]

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KANK-A MOUTH PAIN (BENZOCAINE) LIQUID [BLISTEX INC.]
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NDC 10157-9477-1
Set ID eebc03ba-f849-4e70-a653-834f383b6aa4
Category HUMAN OTC DRUG LABEL
Packager Blistex Inc.
Generic Name
Product Class
Product Number
Application Number PART346
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzocaine 20.0% (w/w)

  • Purpose

    Oral anesthetic/analgesic

  • Uses

    • for the temporary relief of pain due to 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 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

    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.

    Do not use

    • for teething
    • in children under 2 years of age

    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

    • adults and children 2 years of age and older:
      • to assure formation of a long-lasting film coating, dry affected area and apply medication undiluted with applicator
      • allow a few seconds for coating to form
      • 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: do not use
  • Other information

    • do not purchase if package has been opened
    • cap tightly after use to avoid evaporation
    • avoid contact with the eyes
    • avoid contact with clothing and household/ furniture surfaces to prevent possible staining
    • this is a personal care item, and should be used by one individual only
  • Inactive ingredients

    benzyl alcohol, cetylpyridinium chloride, compound benzoin tincture, dimethyl isosorbide, ethylcellulose, flavor, octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer, oleth-10, PEG-6, propylene glycol, ricinus communis (castor) seed oil, SD alcohol 38B (29.6% v/v), sodium saccharin, sucralose, tannic acid

  • PRINCIPAL DISPLAY PANEL - 9.75 mL Bottle Package

    MAXIMUM
    STRENGTH

    Blistex®

    KANK+A®
    MOUTH PAIN LIQUID
    ORAL ANESTHETIC

    Maximum Pain Relief

    Forms Protective Coating

    For Sores Inside the Mouth

    Canker Sores
    Denture Abrasions
    Brace Irritation

    ADA
    Accepted
    American
    Dental
    Association
    ®

    CONVENIENT
    CONTROL-TIP
    APPLICATOR

    Net 0.33 fl. oz. (9.75 mL)

    Principal Display Panel - 9.75 mL Bottle Package
  • INGREDIENTS AND APPEARANCE
    KANK-A   MOUTH PAIN
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9477
    Route of AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    POLYOXYL-10 OLEYL ETHER (UNII: JD797EF70J)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TANNIC ACID (UNII: 28F9E0DJY6)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9477-19.75 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product12/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34612/01/2011
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-9477)
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