FDA Label for Cankermelts
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH SELF-ADHERING TABLET)
- PURPOSE
- USES
- METHEMOGLOBINEMEA WARNING:
- ALLERGY ALERT:
- DO NOT USE:
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR OR DENTIST IF:
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN
- ADULTS AND CHILDREN AGE 5 AND OLDER:
- PLACEMENT:
- CHILDREN UNDER 5 YEARS OF AGE:
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- CANKERMELTS® 15MG CARTON OF 20
Cankermelts Product Label
The following document was submitted to the FDA by the labeler of this product Quest Products, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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
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.
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
* Please review the disclaimer below.
