Active Ingredient (In Each Self-Adhering Tablet)
Benzocaine 15mg
The following Structured Product Label (SPL) was submitted to the FDA by Quest Products, Llc for the product Cankermelts (NDC 68229-700). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Benzocaine 15mg
Oral Pain Relief
for temporary relief of pain associated with:
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:
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 exceed recommended dosage.
ask a health professional before use.
in case of overdose, get medical help or contact a Poison Control Center right away.
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.
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.
Acacia gum, cellulose gum, hyaluronic acid, magnesium stearate, maize dextrin, methylcobalamin (vitamin B12), mint oil, sodium bicarbonate, xylitol
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