Ingredients
Each gram of 20% benzocaine gel contains between 180-220 mg benzocaine U.S.P., in a water soluble base of PEG 3350 U.S.P., PEG 400 U.S.P., flavor, sodium saccharin U.S.P., and FD&C Red #40.
Topical Anesthetic
FDA Label NDC 50227-2116
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Patterson Dental for the product Topical Anesthetic (NDC 50227-2116). 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 ingredients, usual dosage, caution, warning, storage and handling, principal display panel - 29.6 ml label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Usual Dosage
For oral mucosal use only as directed by a dentist.
Caution
Contains FD&C Yellow #5 (tartrazine) which may cause an allergenic response. Federal law prohibits dispensing without a prescription.
Warning
Keep out of reach of children. Do not use on people with known allergies to benzocaine and PABA compounds.
Storage And Handling
Store at controlled room temperature 59-86°F (15-30°C).
Principal Display Panel - 29.6 Ml Label
PATTERSON
DENTAL
Topical Anesthetic
Banana Flavor Gel
Contains 20% Benzocaine
For Professional Use Only
Net Contents 1 fl oz (29.6 mL)
Reorder Number
089-9989
Principal Display Panel (Patterson 01)
* Please review the disclaimer below.
