说明与适用边界
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spl product data elements
PureLife Topical Anesthetic Benzocaine POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 FD&C RED NO. 3 FD&C RED NO. 40 FD&C BLUE NO. 1 FD&C GREEN NO. 3 D&C RED NO. 28 D&C GREEN NO. 5 BENZOCAINE BENZOCAINE
活性成分 / Active ingredient
Active Ingredients Benzocaine 200mg (in each g)
用途 / Purpose
Purpose Oral Anesthetic
适应证 / Indications and usage
Use For oral mucosa only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
警告 / Warnings
Warnings 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 on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. Do not use for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly. for teething in children under 2 years of age When using this product Avoid contact with eyes. If contact occurs, flush with water. Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast feeding, ask a physician before use.
儿童安全 / Keep out of reach of children
Keep out of reach of children.
用法用量原文 / Dosage and administration
Directions Apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use
储存 / Storage and handling
Other Information Store at 59° - 86°F (15°-30°C). Protect from freezing.
辅料 / Inactive ingredients
Inactive Ingredients flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.
questions
Questions or comments? 877-777-3303 or purelifedental.com
package label principal display panel
Purelife_topical_anesthetic.jpg
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 5 / 20250108
- 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.

