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Name:Superdentcherry
Manufacturer:Darby Dental Supply Llc
Category:Prescription Marketed Drugs


Super Dent Topical Anesthetic Gel 20% Benzocaine

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 Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-2002
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g
Product Characteristics
Color RED Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66467-2002-1 34 g in 1 JAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/19/1963

SUPERDENT  MINT
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-2003
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g
Product Characteristics
Color GREEN Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66467-2003-1 34 g in 1 JAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/19/1963

SUPERDENT  BANANA
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-2005
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g
Product Characteristics
Color YELLOW Score     
Shape Size
Flavor BANANA Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66467-2005-1 34 g in 1 JAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/19/1963

SUPERDENT  BUBBLE GUM
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-2001
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g
Product Characteristics
Color PINK Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66467-2001-1 34 g in 1 JAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/19/1963

SUPERDENT  STRAWBERRY
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-2006
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g
Product Characteristics
Color RED Score     
Shape Size
Flavor STRAWBERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66467-2006-1 34 g in 1 JAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/19/1963

SUPERDENT  RASPBERRY
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-2000
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g
Product Characteristics
Color RED Score     
Shape Size
Flavor RASPBERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66467-2000-1 34 g in 1 JAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/19/1963

SUPERDENT  PINA COLADA
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-2004
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g
Product Characteristics
Color WHITE Score     
Shape Size
Flavor COCONUT (Pina Colada) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66467-2004-1 34 g in 1 JAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/19/1963

Labeler - Darby Dental Supply LLC (825137818)
Registrant - DSHealthcare (056296981)
Establishment
Name Address ID/FEI Operations
DENTSPLY Caulk 083235549 MANUFACTURE

Revised: 08/2010 Darby Dental Supply LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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