Label: CANKERMELTS- benzocaine lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 26, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredient (in each self-adhering tablet)

    Benzocaine 15mg

  • Purpose

    Oral Pain Relief

  • Uses

    for temporary relief of pain associated with:

    • canker sores
    • minor irritation
    • mouth sores
  • Warnings

    Methemoglobinemea warning:

    Use of this product may cause methemoglobinemea, a serious- condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. 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:

    • this product for more than 7 days unless directed by a doctor or dentist
    • in children under 5 years of age
    • for teething

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a doctor or dentist if:

    • if sore mouth symptoms do not improve in 7 days
    • if irritation, pain, or redness persists or worsens
    • if swelling, rash or fever develops

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children

    in case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children age 5 and older:

    Affix one tablet as directed below and allow to slowly dissolve in the mouth. May be repeated every 2 hours as needed or directed by a doctor or dentist. This product may last over 2 hours.

    Placement:

    CankerMelts are bi-layered tablets with a dimple on the adhesive side and a pain reliever on the domed side marked CM. Place the adhesive side with a dimple against teeth or gums or braces or appliance. Place opposite or adjacent to the sore. Hold tablet in place with your cheek or tongue for 10 seconds to initiate adhesion. Adhesion will strengthen over the next few minutes. It may be removed at any time.

    Children under 5 years of age:

    Do not use.

  • Other Information

    • Protect from humidity
    • Store at 15°C - 30°C (59°F - 86°F)
  • Inactive Ingredients

    Acacia gum, cellulose gum, hyaluronic acid, magnesium stearate, maize dextrin, methylcobalamin (vitamin B12), mint oil, sodium bicarbonate, xylitol

  • CankerMelts® 15mg carton of 20

    20carton

  • INGREDIENTS AND APPEARANCE
    CANKERMELTS 
    benzocaine lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-700
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYALURONIC ACID (UNII: S270N0TRQY)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    XYLITOL (UNII: VCQ006KQ1E)  
    METHYLCOBALAMIN (UNII: BR1SN1JS2W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    Colorwhite (bi-layered; slightly pink/off-white) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code CM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68229-700-201 in 1 CARTON10/06/2023
    120 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02210/06/2023
    Labeler - Quest Products, LLC (075402441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Quest Products, LLC116971363manufacture(68229-700)