CANKERMELTS- benzocaine lozenge 
Quest Products, LLC

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CankerMelts®

Active Ingredient (in each self-adhering tablet)

Benzocaine 15mg

Purpose

Oral Pain Relief

Uses

for temporary relief of pain associated with:

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

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

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)

Revised: 1/2024
Document Id: 0fdb6f74-619e-247a-e063-6294a90a96dd
Set id: 070dae82-14c2-66d2-e063-6394a90ab259
Version: 2
Effective Time: 20240126
 
Quest Products, LLC