说明与适用边界
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spl product data elements
HurriCaine Topical Anesthetic Benzocaine POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM BENZOCAINE BENZOCAINE Pina Colada
活性成分 / Active ingredient
Active ingredient Benzocaine 20%
用途 / Purpose
Purpose Oral Anesthetic
适应证 / Indications and usage
Uses for the temporary relief of occasional minor irritation and pain, associated with: canker sores sore mouth and throat minor injury of the mouth and gums minor dental procedures minor irritation of the mouth and gums caused by dentures or orthodontic appliances
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 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 if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.
停用事项 / Stop use
Do not use Do not use: if the tube has been punctured or previously opened for teething in children under 2 years of age
使用中 / When using
When using this product avoid contact with eyes
儿童安全 / Keep out of reach of children
Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
用法用量原文 / Dosage and administration
Directions Directions: Do not exceed recommended dosage. adults and children 2 years of age and older: apply to the affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor. children under 12 years of age: should be supervised in the use of the product children under 2 years of age: do not use
储存 / Storage and handling
Other information store at 20°-25° C (68°-77° F)
辅料 / Inactive ingredients
Inactive ingredients flavor, polyethylene glycol, sodium saccharin
questions
Questions or comments? 1-800-238-8542 M-F: 8:00 a.m. - 4:30 p.m. ET
package label principal display panel
Principal Display Panel HURRICAINE® Topical Anesthetic GEL 20% Benzocaine Oral Anesthetic PINA COLADA Manufactured for: Beutlich® Pharmaceuticals, LLC Bunnell, FL Made in the USA 1 Tube - NET WT. 1.5 oz. (42.52 g) primary container label
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20241029
- 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.

