Topical Anesthetic

FDA Drug Profile — HurriCaine, Benzocaine

Drug Details

Generic Name
Topical Anesthetic
Brand Names
HurriCaine, Benzocaine
Application Number
M022
Sponsor
Beutlich Pharmaceuticals LLC
NDC Codes
2
Dosage Forms
SPRAY
Routes
DENTAL, PERIODONTAL
Active Ingredients
BENZOCAINE

Indications and Usage

Uses for the temporary relief of occasional minor irritation and pain associated with sore mouth and 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 if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. ​Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.