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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.

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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
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50227-2116
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350  
POLYETHYLENE GLYCOL 400  
SACCHARIN SODIUM  
FD&C RED NO. 40  
Product Characteristics
Color      Score     
Shape Size
Flavor BANANA Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:50227-2116-1 34 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part356 02/19/1963
Labeler - Patterson Dental (171843584)
Registrant - DSHealthcare (056296981)
Establishment
Name Address ID/FEI Operations
DENTSPLY Caulk 083235549 MANUFACTURE
Revised: 05/2010
 
Patterson Dental



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