Oral Pain Reliever

FDA Drug Profile — Orajel Rescue Relief Pen, Orajel 2X Medicated Gel

Drug Details

Generic Name
Oral Pain Reliever
Brand Names
Orajel Rescue Relief Pen, Orajel 2X Medicated Gel
Application Number
M022
Sponsor
Church & Dwight Co., Inc.
NDC Codes
2
Dosage Forms
GEL
Routes
ORAL, TOPICAL
Active Ingredients
BENZOCAINE, MENTHOL, ZINC CHLORIDE

Indications and Usage

USES • for the temporary relief of • pain due to minor irritation or injury of the mouth and gums • occasional sore mouth and sore throat

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 DO NOT USE • more than directed • for more than 7 days unless directed by a dentist or doctor • for teething • in children under 2 years of age STOP USE AND ASK A DENTIST OR DOCTOR IF • sore throat is severe, persists for more than 2 days • sore mouth symptoms do not improve in 7 days • headache, nausea, vomiting, swelling, rash or fever develops • irritation, pain or redness persists or worsens KEEP OUT OF REACH OF CHILDREN In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.