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.
