说明与适用边界
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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.

