Benzocaine 20% MOUTH SORE AND TOOTHACHE

FDA Drug Profile — TideFresh MOUTH SORE AND TOOTHACHE

Benzocaine 20% MOUTH SORE AND TOOTHACHE is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including TideFresh MOUTH SORE AND TOOTHACHE. Available dosage form: spray.

Drug Details

Generic Name
Benzocaine 20% MOUTH SORE AND TOOTHACHE
Brand Names
TideFresh MOUTH SORE AND TOOTHACHE
Application Number
M022
Sponsor
Wenzhou Yuyuan Pharmaceutical Co., Ltd.
NDC Codes
1
Dosage Forms
SPRAY
Routes
TOPICAL
Active Ingredients
BENZOCAINE

Indications and Usage

Use Temporarily relieves pain and minor irritation of the mouth and gums due to canker sores.

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