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西药 · 美国药品标签原文

苯佐卡因 · CankerMelts

BENZOCAINE

CankerMelts · Quest Products, LLC。此记录对应特定产品,标签收录不代表所有用途获批。

说明与适用边界

此页按所列地区、版本归档。标签内容可能更新,具体产品请核对原始来源;本站关联表示阅读线索,不表示药品与器械可兼容或可替换。

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.
核对原始来源