Active Ingredients
Benzocaine 200 mg (in each g)
Bencocaine Topical Anesthetic Gel
FDA Label NDC 66975-340
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Benco Dental for the product Bencocaine Topical Anesthetic (NDC 66975-340). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, indications & usage, warnings, allergy alert, do not use, when using this product, do not exceed recommended dosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral Anesthetic
Indications & Usage
For oral mucosal use only, as directed by dentist. For the temporary relif of pain due to minor dental procedures.
Warnings
Warnings
Methemoglolllnemla
warning: Use of this product
may cause methemoglobinemia,
a seriouscondit~n that must be
treated promptly because tt
reduces the amount of oxygen
carried in the 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
Allergy Alert Do not use on
patients with a history of
allergies to local anesthetics
suchasprocaine,butacaine,
benzocaine or other "caine"
anesthetics.
Do Not Use
•for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or worsens; or if swelling, rash or fever develops,see your physician promptly.
• for teething
•in children under 2 years of age
When Using This Product
Avoid contact with eyes. If contact occurs, flush with water.
Do Not Exceed Recommended Dosage
If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast Feeding,
ask a physician before use.
Directions
• Apply only amount needed to
the oral mucosa to prevent or
relieve pain.
• children under 2 years of age:
do not use
Other Information
Store at 59 -86°F(15-30°C).
Protect from freezing.
Inactive Ingredients
flavoring, PEG 3350, PEG 400, sodium saccharin.
Questions Or Comments?
800.GO.BENCO or benco.com
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