Topicale
Generic: BENZOCAINE
Basic Information
Manufacturer
Medical Products Laboratories, Inc.
Product Type
HUMAN OTC DRUG
Route of Administration
ORAL
FDA Set ID
8281700c-10f9-841c-e053-2991aa0a918f
Purpose
Oral Anesthetic
Indications & Usage
For the temporary relief of minor pain and irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedures, minor irritation of the mouth and gums caused by dentures or orthodontic appliances
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, grey or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy.
Do not use for Teething Do not use in children under 2 years of age Do not use in large quantities or over large areas of body Allergy Alert: Do not use if you have a history of allergy to local anesthetics such as benzocaine, butacaine, procaine or other "caine" anesthetics When using this product Avoid contact with eyes In case of accidental overdose, get medical help or contact a Poison Control Centre immediately Stop use and ask a doctor If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens
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, grey or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy.
Do not use for Teething Do not use in children under 2 years of age Do not use in large quantities or over large areas of body Allergy Alert: Do not use if you have a history of allergy to local anesthetics such as benzocaine, butacaine, procaine or other "caine" anesthetics When using this product Avoid contact with eyes In case of accidental overdose, get medical help or contact a Poison Control Centre immediately Stop use and ask a doctor If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens