Benzocaine and White Petrolatum

FDA Drug Profile — Orajel for Cold Sores Double Medicated, Cream

Drug Details

Generic Name
Benzocaine and White Petrolatum
Brand Names
Orajel for Cold Sores Double Medicated, Cream
Application Number
M017
Sponsor
Church & Dwight Co., Inc.
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
BENZOCAINE, PETROLATUM

Indications and Usage

Use temporarily relieves pain, itching and dryness; softens crusts (scabs) associated with • cold sores • fever blisters

Warnings

Warnings For external use only 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