Cankermelts®

Cankermelts®
SPL v5
SPL
SPL Set ID 070dae82-14c2-66d2-e063-6394a90ab259
Route
ORAL
Published
Effective Date 2025-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (15 mg)
Inactive Ingredients
Hydroxypropylcellulose Hyaluronic Acid Peppermint Oil Sodium Bicarbonate Magnesium Stearate Xylitol Methylcobalamin Maltodextrin Carboxymethylcellulose Sodium, Unspecified Form Acacia

Identifiers & Packaging

Pill Appearance
Imprint: CM Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-06

Description

Benzocaine 15mg

Purpose

Oral Pain Relief


Medication Information

Purpose

Oral Pain Relief

Description

Benzocaine 15mg

Uses

for temporary relief of pain associated with:

  • canker sores
  • minor irritation
  • mouth sores
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.

Do Not Use:
  • this product for more than 7 days unless directed by a doctor or dentist
  • in children under 5 years of age
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.

Active Ingredient

Benzocaine 15mg

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

When Using This Product

do not exceed recommended dosage.

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
Keep Out of Reach of Children

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

Children Under 5 Years of Age:

Do not use.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Cankermelts® 15mg Carton of 20

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.

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

Structured Label Content

Uses

for temporary relief of pain associated with:

  • canker sores
  • minor irritation
  • mouth sores
Purpose

Oral Pain Relief

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.

Do Not Use: (Do not use:)
  • this product for more than 7 days unless directed by a doctor or dentist
  • in children under 5 years of age
Allergy Alert: (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.

Active Ingredient

Benzocaine 15mg

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

When Using This Product (When using this product)

do not exceed recommended dosage.

Methemoglobinemea Warning: (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
Keep Out of Reach of Children (Keep out of reach of children)

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

Children Under 5 Years of Age: (Children under 5 years of age:)

Do not use.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Cankermelts® 15mg Carton of 20 (CankerMelts® 15mg carton of 20)

Adults and Children Age 5 and Older: (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.

Stop Use and Ask A Doctor Or Dentist If: (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

Advanced Ingredient Data


Raw Label Data

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