Pain Relief
Generic: BENZOCAINE
Basic Information
Manufacturer
Safetec of America, Inc.
Product Type
HUMAN OTC DRUG
Route of Administration
TOPICAL
FDA Set ID
de84e598-d047-4fae-b2ed-155a3788bc6f
Purpose
Purpose Oral pain reliever
Indications & Usage
Uses temporarily relieves pain caused by toothache dental work minor irritation or injury of the mouth and gums canker sores gum sores cheek bites denture irritation
Warnings
Warnings For oral use only.
Avoid contact with eyes.
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 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 βcaineβ anesthetics.
If a skin reaction occurs, stop use and seek medical help right away.
Do not use for teething in children under 2 years of age When using this product Do not use for more than 7 days unless directed by a dentist or doctor.
If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly.
Do not exceed recommended dosage.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Avoid contact with eyes.
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 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 βcaineβ anesthetics.
If a skin reaction occurs, stop use and seek medical help right away.
Do not use for teething in children under 2 years of age When using this product Do not use for more than 7 days unless directed by a dentist or doctor.
If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly.
Do not exceed recommended dosage.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.