Sensicaine Tm Extra
FDA Label NDC 67239-0217

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safco Dental Supply Co. for the product Sensicaine Tm Extra (NDC 67239-0217). 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 ingridients (in each gram), purpose, use, warnings, do not use, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingridients (in Each Gram)

→ Purpose

→ Use

→ Warnings

→ Do Not Use

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - Jar Label

Active Ingridients (In Each Gram)

Benzocaine 200 mg

Purpose

Oral Anesthetic

Use

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

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 on patients with a history of allergies to local anesthetics such as 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 if irritation,pain, or redness persist or worsen, see your dentist or doctor promptly.

Do Not Use

for teething
in children under 2 years of age

Directions

adults and children 2 years of age and older: apply only amount needed to the oral mucosa to prevent or relieve pain
children under 2 years of age: do not use