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西药 · 美国药品标签原文

Finafta

BENZOCAINE, GLYCERIN

Finafta · Efficient Laboratories Inc.。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

Finafta Benzocaine, Glycerin PROPYLPARABEN POLYETHYLENE GLYCOL 1000 PHOSPHORIC ACID BENZOCAINE BENZOCAINE MENTHOL SUCRALOSE METHYLPARABEN PROPYLENE GLYCOL WATER GLYCERIN GLYCERIN

活性成分 / Active ingredient

Active Ingredients: (%) Purpose Benzocaine USP 5%..................Oral Anesthetic Glycerin 33% .........................Oral Demulcen

用途 / Purpose

Purpose Oral Anesthetic Oral Demulcen

适应证 / Indications and usage

Uses For temporary relief of pain associated with canker sores

警告 / Warnings

Warnings Do not exceed recommended dosage Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the 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 t his product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.

儿童安全 / Keep out of reach of children

Keep out of reach of children. In case of accidental 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 over 12 years of age apply to the affected area, mouth, gums or mucous membrane with the applicator provided, up to 4 times daily or as directed by a dentist or doctor. Remain in place at least 1 minute and then spit out. Do not rinse mouth after each use • Children between 2 and 12 years of age: consult a doctor •children under 12 years of age should be supervised in the use of the product •do not use in children under 2 years of age.

questions

Questions or comments? 305-805-3456 Monday-Friday (9 a.m. - 5 p.m. EST) www.efficientlabs.com

辅料 / Inactive ingredients

Inactive Ingredients: menthol, methylparaben, polyethylene glycol, propylparaben, propylene glycol, purified water, phosphoric acid, sucralose.

其他安全资料 / Other safety information

Other Information • finafta is tolerable to iodine-sensitive individuals. • store between 15° - 30°C (59° - 86°F). • close bottle tightly after each use. • Keep box for information. Tamper-Evident:do not accept if safety seal is broken or missing.

package label principal display panel

label

来源、版本与许可

资料类型
美国药品标签原文
版本
7 / 20251014
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