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Topex

DENTSPLY Caulk

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 - 100 gram Jar Label

NPN 00638358

TOPEX®
TOPICAL
ANESTHETIC
GEL

(Benzocaine 20%)

CHERRY

Net Content 100g

Topex

PRINCIPAL DISPLAY PANEL - 100 gram Jar Label

NPN 00638358

TOPEX®
TOPICAL
ANESTHETIC
GEL

(Benzocaine 20%)

MINT

Net Content 100g

Topex

PRINCIPAL DISPLAY PANEL - 100 gram Jar Label

NPN 00638358

TOPEX®
TOPICAL
ANESTHETIC
GEL

(Benzocaine 20%)

PIÑA COLADA

Net Content 100g

Topex

PRINCIPAL DISPLAY PANEL - 100 gram Jar Label

NPN 00638358

TOPEX®
TOPICAL
ANESTHETIC
GEL

(Benzocaine 20%)

BUBBLE NUM®

Net Content 100g

Topex

Topex

Benzocaine GEL, DENTIFRICE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:10216-3071
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:10216-3071-1 100 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:10216-3081
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:10216-3081-1 100 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:10216-3091
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:10216-3091-1 100 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:10216-3110
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:10216-3110-1 100 in 1 JAR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
1963-02-19


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Be sure to consult your doctor before taking any medication!
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