说明与适用边界
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spl product data elements
CankerMelts benzocaine HYDROXYPROPYLCELLULOSE HYALURONIC ACID PEPPERMINT OIL SODIUM BICARBONATE MAGNESIUM STEARATE XYLITOL METHYLCOBALAMIN MALTODEXTRIN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM BENZOCAINE BENZOCAINE ACACIA CM bi-layered; slightly pink/off-white
活性成分 / Active ingredient
Active Ingredient (in each self-adhering tablet) Benzocaine 15mg
用途 / Purpose
Purpose Oral Pain Relief
适应证 / Indications and usage
Uses for temporary relief of pain associated with: canker sores minor irritation mouth sores
警告 / Warnings
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 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.
警告和注意事项 / Warnings and precautions
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
患者须知 / Information for patients
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.
禁用事项 / 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
使用中 / When using
When using this product do not exceed recommended dosage.
停用事项 / Stop use
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
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
儿童安全 / 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.
用法用量原文 / Dosage and administration
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.
使用说明 / Instructions for use
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.
其他安全资料 / Other safety information
Other Information Protect from humidity Store at 15°C - 30°C (59°F - 86°F)
辅料 / Inactive ingredients
Inactive Ingredients Acacia gum, cellulose gum, hyaluronic acid, magnesium stearate, maize dextrin, methylcobalamin (vitamin B12), mint oil, sodium bicarbonate, xylitol
package label principal display panel
CankerMelts® 15mg carton of 20 PDP
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 5 / 20251204
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

