FDA Label for Topical Anesthetic Banana
View Indications, Usage & Precautions
Topical Anesthetic Banana Product Label
The following document was submitted to the FDA by the labeler of this product Patterson Dental. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
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
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