Super Dent Topical Anesthetic Gel

benzocaine

Dosage Form: gel
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 NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color RED Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 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 NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color GREEN Score      Shape Size Flavor MINT Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 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 NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW Score      Shape Size Flavor BANANA Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 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 NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color PINK Score      Shape Size Flavor BUBBLE GUM Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 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 NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color RED Score      Shape Size Flavor STRAWBERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 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 NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color RED Score      Shape Size Flavor RASPBERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 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 NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score      Shape Size Flavor COCONUT (Pina Colada) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 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: 08/2010Darby Dental Supply LLC

More Super Dent Topical Anesthetic Gel resources

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