说明与适用边界
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spl product data elements
Family Wellness Oral Pain Relief Benzocaine 20% BENZOCAINE BENZOCAINE GLYCERIN POLYSORBATE 80 PROPYLENE GLYCOL SACCHARIN SODIUM D&C RED NO. 33 FD&C YELLOW NO. 6 BENZYL ALCOHOL FD&C BLUE NO. 1 CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE POLYETHYLENE GLYCOL, UNSPECIFIED SORBIC ACID
活性成分 / Active ingredient
Active ingredients Benzocaine 20%
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 canker sores minor dental procedures dentures sore gums braces
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 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 the eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a doctor/dentist Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness lasts or worsens swelling, rash, or fever develops 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 right away.
使用中 / When using
When using this product: avoid contact with the eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a doctor/dentist
停用事项 / Stop use
Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness lasts or worsens swelling, rash, or fever develops
儿童安全 / Keep out of reach of children
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 right away.
用法用量原文 / Dosage and administration
Directions adults and children 2 years of age and over apply a pea-size amount 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 thin layer to the affected area do not reinsert dental work until irritation/pain is relieved rinse mouth well before reinserting
dosage and administration table
<table border="1" width="100%"><tbody><tr><td>adults and children 2 years of age and over</td><td>apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist</td></tr><tr><td>children under 12 years of age</td><td>adult supervision should be given in the use of this product</td></tr><tr><td>children under 2 years of age</td><td>do not use</td></tr></tbody></table>
其他安全资料 / Other safety information
Other information store at 20-25°C (68-77°F) do not refrigerate
辅料 / Inactive ingredients
Inactive ingredients benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, sodium saccharin, sorbic acid
package label principal display panel
PRINCIPAL DISPLAY PANEL
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20251008
- 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.

