TOPEX- benzocaine gel, dentifrice

Topex by

Drug Labeling and Warnings

Topex by is a Prescription medication manufactured, distributed, or labeled by DENTSPLY Caulk. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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 - 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

INGREDIENTS AND APPEARANCE

TOPEX 
benzocaine gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10216-3071
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	220 mg  in 1 g

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10216-3071-1	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	Item Code (Source)	NDC: 10216-3081
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	220 mg  in 1 g

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10216-3081-1	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	Item Code (Source)	NDC: 10216-3091
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	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	Marketing Start Date	Marketing End Date
1	NDC: 10216-3091-1	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	Item Code (Source)	NDC: 10216-3110
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	220 mg  in 1 g

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10216-3110-1	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 - DENTSPLY Caulk (083235549)

Establishment
Name	Address	ID/FEI	Business Operations
DENTSPLY Caulk		083235549	MANUFACTURE