TOPICAL ANESTHETIC  BUBBLE GUM- benzocaine gel 
Patterson Dental Supply Inc

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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Patterson Topical Anesthetic Bubble Gum Flavor

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 #28.

USUAL DOSAGE

For oral mucosal use only as directed by a dentist.

CAUTION

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
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120

PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label

PATTERSON
DENTAL

NDC#50227-2114-1

Topical Anesthetic

Bubble Gum Flavor Gel

Contains 20% Benzocaine

For Professional Use Only

Net Contents 1 fl oz (29.6 mL)

Reorder Number
090-0035

PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label
TOPICAL ANESTHETIC   BUBBLE GUM
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50227-2114
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 400 (UNII: B697894SGQ)  
Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY)  
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50227-2114-129.6 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 Supply Inc (171843584)

Revised: 4/2012
Document Id: 561311f4-566e-454f-a451-1b84ebfad810
Set id: 1bed9e20-6244-4bad-a934-220e0c369d79
Version: 1
Effective Time: 20120406
 
Patterson Dental Supply Inc