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| Product NDC Code | 68229-700 | ||||
|---|---|---|---|---|---|
| Drug Name | Cankermelts |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LOZENGE | ||||
| RxCUI drug identifier | 199071 | ||||
| Application Number | M022 | ||||
| Labeler Name | Quest Products, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each self-adhering tablet) Benzocaine 15mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Acacia gum, cellulose gum, hyaluronic acid, magnesium stearate, maize dextrin, methylcobalamin (vitamin B12), mint oil, sodium bicarbonate, xylitol
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses for temporary relief of pain associated with: canker sores minor irritation mouth sores
Purpose
Information about the drug product’s indications for use.Purpose Oral Pain Relief
Spl product data elements
Usually a list of ingredients in a drug product.CankerMelts benzocaine HYALURONIC ACID PEPPERMINT OIL SODIUM BICARBONATE XYLITOL METHYLCOBALAMIN MAGNESIUM STEARATE MALTODEXTRIN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM BENZOCAINE BENZOCAINE ACACIA bi-layered; slightly pink/off-white CM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.CankerMelts® 15mg carton of 20 20carton
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
CankerMelts: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.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.
Instructions for use
Information about safe handling and use of the drug product.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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children in case of overdose, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Protect from humidity Store at 15°C - 30°C (59°F - 86°F)
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not exceed recommended dosage.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API