DSHealthcare
Topex Topical Anesthetic Gel/Liquid – 20% Benzocaine
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
DIRECTIONS FOR USE
Gel – 1oz/30mL
REF AD31001 Cherry
REF AD31002 Mint
REF AD31003 Banana
REF AD31004 Pina Colada
REF AD31005 Bubble-Num
REF AD31006 Strawberry
REF AD31007 Razzberry
Gel – 100g jar
REF AD31064 Cherry
REF AD31964 Mint
REF AD31067 Pina Colada
REF AD31068 Bubble-Num
Liquid – 1oz/30mL
REF AD31011 Cherry
REF AD31012 Mint
REF AD31014 Pina Colada USP – 2oz/57g
NPN Number: 00638358
For dental use only.
USA: Rx only.
1. DESCRIPTION
Flavored 20% benzocaine gel or liquid 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 intraoral 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
Topex 20% benzocaine gels and liquids 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
- Each gram of Topex 20% benzocaine gel or liquid contains between 180-220mg benzocaine in a flavored base.
- 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.
- For topical tissue anesthesia during scaling procedures, dispense a small amount of Topex gel or liquid into a dappen dish, then coat the scaler with the product prior to use.
- Tightly re-cap the jar after each use.
7. STORAGE
Store between 59°-86°F (15°-30°C). Protect from freezing.
SultanHealthcare
411 Hackensack Avenue, 9th Floor, Hackensack, NJ 07601
Toll Free: 800-637-8582 • Phone: 201-871-1232
Fax: 201-871-0321 • www.sultanhealthcare.com
Made in the USA
Form #0030502DF (R 7/22/09)
PRINCIPAL DISPLAY PANEL - 34 gram Jar Label
NPN 00638358
TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)
CHERRY
Net Content 1oz (34g)
PRINCIPAL DISPLAY PANEL - 34 gram Jar Label
NPN 00638358
TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)
MINT
Net Content 1oz (34g)
PRINCIPAL DISPLAY PANEL - 34 gram Jar Label
NPN 00638358
TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)
BANANA
Net Content 1oz (34g)
PRINCIPAL DISPLAY PANEL - 34 gram Jar Label
NPN 00638358
TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)
BUBBLE NUM®
Net Content 1oz (34g)
PRINCIPAL DISPLAY PANEL - 34 gram Jar Label
NPN 00638358
TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)
STRAWBERRY
Net Content 1oz (34g)
PRINCIPAL DISPLAY PANEL - 34 gram Jar Label
NPN 00638358
TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)
RAZZBERRY
Net Content 1oz (34g)
PRINCIPAL DISPLAY PANEL - 100 gram Jar Label
NPN 00638358
TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)
CHERRY
Net Content 100g
PRINCIPAL DISPLAY PANEL - 100 gram Jar Label
NPN 00638358
TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)
MINT
Net Content 100g
PRINCIPAL DISPLAY PANEL - 100 gram Jar Label
NPN 00638358
TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)
PIÑA COLADA
Net Content 100g
PRINCIPAL DISPLAY PANEL - 100 gram Jar Label
NPN 00638358
TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)
BUBBLE NUM®
Net Content 100g
Topex
Benzocaine GEL, DENTIFRICE
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:0699-7021 |
|
Route of Administration
|
DENTAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BENZOCAINE Benzocaine |
|
220 mg
|
Product Characteristics
|
|
Color
|
|
RED |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:0699-7021-34 |
34 in 1 JAR |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
1963-02-19 |
|
|
Topex
Benzocaine GEL, DENTIFRICE
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:0699-7011 |
|
Route of Administration
|
DENTAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BENZOCAINE Benzocaine |
|
220 mg
|
Product Characteristics
|
|
Color
|
|
GREEN |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:0699-7011-34 |
34 in 1 JAR |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
1963-02-19 |
|
|
Topex
Benzocaine GEL, DENTIFRICE
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:0699-7041 |
|
Route of Administration
|
DENTAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BENZOCAINE Benzocaine |
|
220 mg
|
Product Characteristics
|
|
Color
|
|
YELLOW |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:0699-7041-34 |
34 in 1 JAR |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
1963-02-19 |
|
|
Topex
Benzocaine GEL, DENTIFRICE
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:0699-7031 |
|
Route of Administration
|
DENTAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BENZOCAINE Benzocaine |
|
220 mg
|
Product Characteristics
|
|
Color
|
|
PINK |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:0699-7031-34 |
34 in 1 JAR |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
1963-02-19 |
|
|
Topex
Benzocaine GEL, DENTIFRICE
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:0699-7051 |
|
Route of Administration
|
DENTAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BENZOCAINE Benzocaine |
|
220 mg
|
Product Characteristics
|
|
Color
|
|
RED |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:0699-7051-34 |
34 in 1 JAR |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
1963-02-19 |
|
|
Topex
Benzocaine GEL, DENTIFRICE
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:0699-7061 |
|
Route of Administration
|
DENTAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BENZOCAINE Benzocaine |
|
220 mg
|
Product Characteristics
|
|
Color
|
|
RED |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:0699-7061-34 |
34 in 1 JAR |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
1963-02-19 |
|
|
Topex
Benzocaine GEL, DENTIFRICE
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:0699-3001 |
|
Route of Administration
|
DENTAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BENZOCAINE Benzocaine |
|
220 mg
|
Product Characteristics
|
|
Color
|
|
WHITE |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:0699-3001-34 |
34 in 1 JAR |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
1963-02-19 |
|
|
Topex
Benzocaine GEL, DENTIFRICE
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:0699-7071 |
|
Route of Administration
|
DENTAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BENZOCAINE Benzocaine |
|
220 mg
|
Product Characteristics
|
|
Color
|
|
RED |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:0699-7071-01 |
100 in 1 JAR |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
1963-02-19 |
|
|
Topex
Benzocaine GEL, DENTIFRICE
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:0699-7081 |
|
Route of Administration
|
DENTAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BENZOCAINE Benzocaine |
|
220 mg
|
Product Characteristics
|
|
Color
|
|
GREEN |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:0699-7081-01 |
100 in 1 JAR |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
1963-02-19 |
|
|
Topex
Benzocaine GEL, DENTIFRICE
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:0699-7091 |
|
Route of Administration
|
DENTAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BENZOCAINE Benzocaine |
|
220 mg
|
Product Characteristics
|
|
Color
|
|
WHITE |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:0699-7091-01 |
100 in 1 JAR |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
1963-02-19 |
|
|
Topex
Benzocaine GEL, DENTIFRICE
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:0699-7100 |
|
Route of Administration
|
DENTAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BENZOCAINE Benzocaine |
|
220 mg
|
Product Characteristics
|
|
Color
|
|
PINK |
|
|
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:0699-7100-01 |
100 in 1 JAR |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
|
|
1963-02-19 |
|
|
