Topical Anesthetic Dental Gel
Generic Name: benzocaine
Dosage Form: gel
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Topical Anesthetic
Banana Flavor Gel
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.
Store at controlled room temperature 59-86°F (15-30°C).
MADE IN U.S.A.
Distributed by:
PATTERSON
DENTAL
Corporate Office
1031 Mendota Heights Road
Saint Paul, MN 55120
PATTERSON
DENTAL /
Montréal Québec
H3M 3E6
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
| TOPICAL ANESTHETIC BANANA benzocaine gel, dentifrice |
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| Labeler - Patterson Dental (171843584) |
| Registrant - DSHealthcare (056296981) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| DENTSPLY Caulk | 083235549 | MANUFACTURE | |
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