Topex Gel

Generic Name: benzocaine
Dosage Form: gel, dentifrice

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.

Topex® Topical Anesthetic Gel/Liquid –
20% Benzocaine

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.

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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

  1. Each gram of Topex 20% benzocaine gel or liquid 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 or liquid 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.

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) 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:0699-7021-34 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
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) 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:0699-7011-34 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
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) 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:0699-7041-34 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
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) 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:0699-7031-34 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
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) 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:0699-7051-34 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
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) 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:0699-7061-34 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
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) 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:0699-3001-34 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
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) 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:0699-7071-01 100 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
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) 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:0699-7081-01 100 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
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) 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:0699-7091-01 100 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
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) 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:0699-7100-01 100 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 - DSHealthcare (056296981)
Establishment
Name Address ID/FEI Operations
DENTSPLY Caulk 083235549 MANUFACTURE
Revised: 02/2010
 
DSHealthcare



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