TOPICAL ANESTHETIC  BANANA- benzocaine gel, dentifrice 
Patterson Dental

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.

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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

PRINCIPAL DISPLAY PANEL
TOPICAL ANESTHETIC   BANANA
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50227-2116
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBANANAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50227-2116-134 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35602/19/1963
Labeler - Patterson Dental (171843584)
Registrant - DSHealthcare (056296981)
Establishment
NameAddressID/FEIBusiness Operations
DENTSPLY Caulk083235549MANUFACTURE

Revised: 5/2010
Document Id: 69850139-6b9d-4bcd-b448-8a2fdb0bbfa5
Set id: f4fdfcaf-aa95-45a8-ba91-7a8716f6f3d8
Version: 1
Effective Time: 20100513
 
Patterson Dental