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, FD&C Blue #1 and FD&C Red #28.
Topical Anesthetic
FDA Label NDC 50227-2113
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 Supply Inc for the product Topical Anesthetic (NDC 50227-2113). 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, otc - keep out of reach of children, storage and handling, principal display panel - 29.6 ml jar 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
Federal law prohibits dispensing without a prescription.
Otc - Keep Out Of Reach Of Children
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 Jar Label
PATTERSON
DENTAL
NDC#50227-2113-1
Topical Anesthetic
Raspberry Flavor Gel
Contains 20% Benzocaine
For Professional Use Only
Net Contents 1 fl oz (29.6 mL)
Reorder Number
090-0043
Principal Display Panel (29.6 mL Jar Label)
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