Active Ingridients (In Each Gram)
Benzocaine 200 mg
Sensicaine Tm Extra
FDA Label NDC 67239-0213
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 67239-0213). 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, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral Anesthetic
Use
For oral mucosaI use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Warnings
Allergy Alert: Do not useon patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
Directions
Apply only amount needed to the oral mucosa to prevent or relieve pain.
Other Information
Store at 59 - 86°F (15 - 30°C).
Protect from freezing.
Inactive Ingredients
flavoring, PEG 3350, PEG 400, sucralose. May contain D&C Red #33, FD&C Red #40, D&C Green #5, FD&C Yellow #5 as a color additive.
Questions Or Comments?
800-621-2178
www.safcodental.com
Principal Display Panel - Jar Label
SAFCO
SensiCaineTM Extra
Topical Anesthetic Gel
Contains 20% Benzocaine
Mint Flavor
1 oz. (29.6 mL)
For professional use only
Principal Display Panel (29.6 mL Jar Label)
* Please review the disclaimer below.
