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Super Dent Topical Anesthetic Gel

Generic Name: benzocaine
Dosage Form: gel

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.

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 (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 (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 (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 (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 (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 (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

SUPERDENT  CHERRY
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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
1 NDC:66467-2002-1 34 g in 1 JAR
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 LABEL 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
1 NDC:66467-2003-1 34 g in 1 JAR
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 LABEL 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
1 NDC:66467-2005-1 34 g in 1 JAR
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 LABEL 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
1 NDC:66467-2001-1 34 g in 1 JAR
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 LABEL 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
1 NDC:66467-2006-1 34 g in 1 JAR
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 LABEL 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
1 NDC:66467-2000-1 34 g in 1 JAR
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 LABEL 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
1 NDC:66467-2004-1 34 g in 1 JAR
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



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