Topex Gel

benzocaine

Dosage Form: gel, dentifrice
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.

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 NDC Product Code (Source) 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

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 0699-7021-34 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

TOPEX  benzocaine  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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

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 0699-7011-34 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

TOPEX  benzocaine  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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

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 0699-7041-34 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

TOPEX  benzocaine  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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

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 0699-7031-34 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

TOPEX  benzocaine  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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

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 0699-7051-34 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

TOPEX  benzocaine  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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

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 0699-7061-34 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

TOPEX  benzocaine  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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

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 0699-3001-34 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

TOPEX  benzocaine  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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

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 0699-7071-01 100 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

TOPEX  benzocaine  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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

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 0699-7081-01 100 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

TOPEX  benzocaine  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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

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 0699-7091-01 100 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

TOPEX  benzocaine  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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

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 0699-7100-01 100 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 - DSHealthcare (056296981)

Establishment
Name	Address	ID/FEI	Operations
DENTSPLY Caulk		083235549	MANUFACTURE

Revised: 02/2010DSHealthcare

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