Benzocaine and Benzalkonium Chloride

FDA Drug Profile — Oral Pain Relief

Drug Details

Generic Name
Benzocaine and Benzalkonium Chloride
Brand Names
Oral Pain Relief
Application Number
M022
Sponsor
Universal Distribution Center LLC
NDC Codes
1
Dosage Forms
GEL
Routes
TOPICAL
Active Ingredients
BENZALKONIUM CHLORIDE, BENZOCAINE

Indications and Usage

Use ■ for the temporary relief of pain due to toothaches ■ to help protect against infection in minor oral irritation

Warnings

Warnings Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce 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 lightheadness • 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 or other "caine" anesthetics