说明与适用边界
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spl product data elements
Oral Anesthetic Liquid Benzocaine BENZYL ALCOHOL BENZOCAINE BENZOCAINE WATER POLYETHYLENE GLYCOL 400 D&C YELLOW NO. 10 FD&C BLUE NO. 1 SACCHARIN SODIUM SACCHARIN PROPYLENE GLYCOL METHYLPARABEN FD&C RED NO. 40 dark orange/red to brown
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active Ingredient Benzocaine 20.0% (w/w)
用途 / Purpose
Purpose Oral pain reliever
适应证 / Indications and usage
Uses Temporarily relieves pain associated with the following mouth and gum irritations: toothache sore gums canker sores braces minor dental procedures dentures
警告 / Warnings
Warnings METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a rare but serious confition 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 for teething in children under 2 years of age When using this product avoid contact with eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a dentist or doctor Stop use and ask doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops
用法用量原文 / Dosage and administration
Directions Adults and children 2 years of age and older: wipe liquid on with cotton, or cotton swab, or fingertip, apply to the affected area up to 4 times daily or as directed by a doctor/dentist children under 12 years of age: adult supervision should be given in the use of this product children under 2 years of age: do not use for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting
辅料 / Inactive ingredients
Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Flavor, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water
儿童安全 / Keep out of reach of children
Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
package label principal display panel
Card R1
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 5 / 20250812
- 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.

