SUPERDENT CHERRY- benzocaine gel, dentifrice 
SUPERDENT MINT- benzocaine gel, dentifrice 
SUPERDENT BANANA- benzocaine gel, dentifrice 
SUPERDENT BUBBLE GUM- benzocaine gel, dentifrice 
SUPERDENT STRAWBERRY- benzocaine gel, dentifrice 
SUPERDENT RASPBERRY- benzocaine gel, dentifrice 
SUPERDENT PINA COLADA- benzocaine gel, dentifrice 
Darby Dental Supply LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Super Dent Topical Anesthetic Gel 20% Benzocaine

DIRECTIONS FOR USE

Gel – 1oz/30mL
REF 14-31021 Cherry
REF 14-31022 Mint
REF 14-31023 Banana
REF 14-31024 Pina Colada
REF 14-31025 Bubble-Num
REF 14-31026 Strawberry
REF 14-31027 Razzberry

For dental use only.
USA: Rx only.

1. DESCRIPTION

Flavored 20% benzocaine gel for topical mucosal anesthesia.

2. INDICATIONS

Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intra-oral radiographs.

3. CONTRAINDICATIONS

Should not be used with individuals with a known sensitivity to benzocaine or PABA.

4. WARNINGS

Keep out of reach of children. For professional dental use only.

5. PRECAUTIONS

Super Dent 20% benzocaine gels are supplied in multiple use containers. Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle.

6. DOSAGE AND ADMINISTRATION

  1. Each gram of Super Dent 20% benzocaine gel contains between 180-220mg benzocaine in a flavored base.
  2. Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle.
  3. For topical tissue anesthesia during scaling procedures, dispense a small amount of Topex gel into a dappen dish, then coat the scaler with the product prior to use.
  4. Tightly re-cap the jar after each use.

7. STORAGE

Store between 59°-86°F (15°-30°C). Protect from freezing.

Darby Dental Supply LLC
Jericho, NY 11753

Made in the USA
Form #0030502DF (R 2/22/10)

PRINCIPAL DISPLAY PANEL - 30 g Label (Cherry)

super dent®

20% Benzocaine Gel

Cherry Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1737
NDC 6646720021

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

Principal Display Panel - 30 g Label (Cherry)

PRINCIPAL DISPLAY PANEL - 30 g Label (Mint)

super dent®

20% Benzocaine Gel

Mint Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1738
NDC 6646720031

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

Principal Display Panel - 30 g Label (Mint)

PRINCIPAL DISPLAY PANEL - 30 g Label (Banana)

super dent®

20% Benzocaine Gel

Banana Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1743
NDC 6646720051

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

Principal Display Panel - 30 g Label (Banana)

PRINCIPAL DISPLAY PANEL - 30 g Label (Bubble Gum)

super dent®

20% Benzocaine Gel

Bubble Gum Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1736
NDC 6646720011

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

Principal Display Panel - 30 g Label (Bubble Gum)

PRINCIPAL DISPLAY PANEL - 30 g Label (Strawberry)

super dent®

20% Benzocaine Gel

Strawberry Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1744
NDC 6646720061

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

Principal Display Panel - 30 g Label (Strawberry)

PRINCIPAL DISPLAY PANEL - 30 g Label (Raspberry)

super dent®

20% Benzocaine Gel

Raspberry Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1734
NDC 6646720001

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

Principal Display Panel - 30 g Label (Raspberry)

PRINCIPAL DISPLAY PANEL - 30 g Label (Piña Colada)

super dent®

20% Benzocaine Gel

Piña Colada Flavored
Topical Anesthetic Gel

Net Contents: 1 oz (30g)

950-1739
NDC 6646720041

For Professional Use Only

Distributed by Darby Dental Supply, LLC. Jericho, NY 11753

Principal Display Panel - 30 g Label (Piña Colada)
SUPERDENT  CHERRY
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-2002
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-2002-134 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/19/196307/01/2015
SUPERDENT  MINT
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-2003
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-2003-134 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/19/196307/01/2015
SUPERDENT  BANANA
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-2005
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorBANANAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-2005-134 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/19/196307/01/2015
SUPERDENT  BUBBLE GUM
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-2001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-2001-134 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/19/196307/01/2015
SUPERDENT  STRAWBERRY
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-2006
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Product Characteristics
ColorREDScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-2006-134 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/19/196307/01/2015
SUPERDENT  RASPBERRY
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-2000
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Product Characteristics
ColorREDScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-2000-134 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/19/196307/01/2015
SUPERDENT  PINA COLADA
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-2004
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorCOCONUT (Pina Colada) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-2004-134 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/19/196307/01/2015
Labeler - Darby Dental Supply LLC (825137818)
Registrant - DSHealthcare (056296981)
Establishment
NameAddressID/FEIBusiness Operations
DENTSPLY Caulk083235549MANUFACTURE(66467-2002, 66467-2003, 66467-2005, 66467-2001, 66467-2006, 66467-2000, 66467-2004)

Revised: 7/2015
 
Darby Dental Supply LLC