Oral Pain Reliever
Drug Details
- Generic Name
- Oral Pain Reliever
- Brand Names
- Orajel 2X Medicated Gel, Orajel Rescue Relief Pen
- Application Number
- M022
- Sponsor
- Church & Dwight Co., Inc.
- NDC Codes
- 2
- Dosage Forms
- GEL
- Routes
- TOPICAL, ORAL
- Active Ingredients
- BENZOCAINE, MENTHOL, ZINC CHLORIDE
Indications and Usage
USE for the temporary relief of pain due to toothaches
Warnings
WARNINGS Methemogloblnemla 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, butacalne, benzocaine or other "caine" anesthetics