benzocaine, menthol, zinc chloride

FDA Drug Profile — Orajel Gum Pain 3X Medicated

Drug Details

Generic Name
benzocaine, menthol, zinc chloride
Brand Names
Orajel Gum Pain 3X Medicated
Application Number
M022
Sponsor
Church & Dwight Co., Inc.
NDC Codes
1
Dosage Forms
GEL
Routes
TOPICAL
Active Ingredients
BENZOCAINE, MENTHOL, UNSPECIFIED FORM, ZINC CHLORIDE

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