Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride
Drug Details
- Generic Name
- Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride
- Brand Names
- Orajel 4X Medicated For Toothache and Gum, Orajel 4X Medicated For Toothache and Gum, Cream, Orajel 4X Medicated PM For Toothache and Gum
- Application Number
- M022
- Sponsor
- Church & Dwight Co., Inc.
- NDC Codes
- 3
- Dosage Forms
- GEL, CREAM
- Routes
- TOPICAL
- Active Ingredients
- BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, UNSPECIFIED FORM, ZINC CHLORIDE, ZINC CATION
Indications and Usage
Uses for the temporary relief of pain due to minor irritation or injury of the mouth and gums first aid to help prevent 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 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