Super Dent Topical Anesthetic Gel

Name: Super Dent Topical Anesthetic Gel

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.

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.

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 (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 (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

For Healthcare Professionals

Applies to benzocaine topical: compounding powder, mucous membrane gel, mucous membrane liquid, mucous membrane lozenge, mucous membrane paste, mucous membrane powder for reconstitution, mucous membrane spray, mucous membrane swab, mucous membrane tablet disintegrating, rectal ointment, rectal suppository, topical cream, topical gel, topical liquid, topical lotion, topical ointment, topical spray, topical stick, topical swab

Dermatologic

Dermatologic side effects have included contact dermatitis and urticaria.[Ref]

Local

Local side effects have included burning and stinging.[Ref]

Other

Other side effects have included edema.[Ref]

Cardiovascular

Cardiovascular side effects have included angioedema.

Hematologic

Hematologic side effects have included methemoglobinemia. FDA continues to receive reports of methemoglobinemia from postmarketing reporting.[Ref]

Some side effects of Super Dent Topical Anesthetic Gel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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