FDA.reportPublic FDA data

Topex ® Topical Anesthetic Gel 20% Benzocaine

Manufacturer
Dentsply LLC. Professional Division Trading as "Sultan Healthcare" | Dentsply Caulk
Effective date
2025-03-05
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 20:40:46

Label at a glance#

ProductTopex Pina Colada
Active ingredientBENZOCAINE
Label structure20 sections

Indications and uses

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. Apply as required.

Dosage and administration

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 Tightly re-cap the jar after each use.

Storage and handling

Topex 20% benzocaine gel is supplied in multiple use containers. Store between 59°-86°F (15°-30°C). Protect from freezing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DIRECTIONS FOR USE

Gel – 1oz/30mL
AD31001 Cherry
AD31002 Mint
AD31004 Pina Colada
AD31005 Bubble-Num
AD31006 Strawberry
AD31007 Razzberry

Gel – 100g jar
AD31064 Cherry
AD31964 Mint
AD31067 Pina Colada
AD31068 Bubble-Num

For dental use only.
Rx only.

1. INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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. Apply as required.

2. DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

  1. 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
  2. Tightly re-cap the jar after each use.

3. DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Each gram of Topex Topical Anesthetic Gel contains between 180-220 mg benzocaine in a flavored base.

4. CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Do not use onindividuals with a known sensitivity to benzocaine or PABA.

5. WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

METHEMOGLOBINEMIA WARNING:

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if the patient in your care develops:

  • pale, gray or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Not for use in children under 2 years of age
Keep out of reach of children
For professional dental use only
Take care not to contaminate the jar by reintroducing a used cotton applicator into the jar

6. OVERDOSAGE

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

7. DESCRIPTION

DESCRIPTION SECTION

Flavored 20% benzocaine gel or liquid for topical mucosal anesthesia.

8. HOW SUPPLIED / STORAGE AND HANDLING

STORAGE AND HANDLING SECTION

Topex 20% benzocaine gel is supplied in multiple use containers.

Store between 59°-86°F (15°-30°C). Protect from freezing.

MANUFACTURED FOR

SPL UNCLASSIFIED SECTION

Sultan Healthcare

1301 Smile Way • York, PA 17404 • USA

Toll Free: 800-637-8582 • Phone: 201-871-1232

Fax: 201-871-0321 • www.sultanhealthcare.com

Made in the USA
0031001DF, R4-072017

PRINCIPAL DISPLAY PANEL - Cherry 34 Gram

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cherry 1 ozCherry 1 oz

PRINCIPAL DISPLAY PANEL - Mint 34 gram

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mint 1 ozMint 1 oz

PRINCIPAL DISPLAY PANEL - Pina Colada 34 gram

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P Colada 1 ozP Colada 1 oz

PRINCIPAL DISPLAY PANEL - Bubble Num 34 gram

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

B Num 1 ozB Num 1 oz

PRINCIPAL DISPLAY PANEL - Strawberry 34 gram

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Strawberry 1 ozStrawberry 1 oz

PRINCIPAL DISPLAY PANEL - Razzberry 34 gram

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Razzberry 1 ozRazzberry 1 oz

PRINCIPAL DISPLAY PANEL - Cherry 100 gram

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cherry 100 gramCherry 100 gram

PRINCIPAL DISPLAY PANEL - Mint 100 gram

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mint 100 gMint 100 g

PRINCIPAL DISPLAY PANEL - Pina Colada 100 gram

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P Colada 100 gP Colada 100 g

PRINCIPAL DISPLAY PANEL - Bubble Num 100 gram

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

B Num 100 gB Num 100 g

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0699-7001-342020-08-19C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7011-342020-08-19C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7021-342020-08-19C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7031-342020-08-19C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7051-342020-08-19C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7061-342020-08-19C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7071-012020-08-19C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7081-012020-08-19C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7091-012020-08-19C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7100-012020-08-19C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7001-342020-07-22C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7011-342020-07-22C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7021-342020-07-22C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7031-342020-07-22C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7051-342020-07-22C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7061-342020-07-22C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7071-012020-07-22C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7081-012020-07-22C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7091-012020-07-22C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine
0699-7100-012020-07-22C16284748780-1ab0e2407-2ba8-f274-e053-dbdaa90a6471Topex ® Topical Anesthetic Gel 20% Benzocaine

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0699-7001TOPEX PINA COLADA (BENZOCAINE) GEL, DENTIFRICE TOPEX CHERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX MINT (BENZOCAINE) GEL, DENTIFRICE TOPEX BUBBLE GUM (BENZOCAINE) GEL, DENTIFRICE TOPEX STRAWBERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX RASPBERRY (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "SULTAN HEALTHCARE"]10Legacy NDC20250308_87083cc6-fedc-4676-84e1-3134f690dfa9.zip
0699-7011TOPEX PINA COLADA (BENZOCAINE) GEL, DENTIFRICE TOPEX CHERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX MINT (BENZOCAINE) GEL, DENTIFRICE TOPEX BUBBLE GUM (BENZOCAINE) GEL, DENTIFRICE TOPEX STRAWBERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX RASPBERRY (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "SULTAN HEALTHCARE"]10Legacy NDC20250308_87083cc6-fedc-4676-84e1-3134f690dfa9.zip
0699-7021TOPEX PINA COLADA (BENZOCAINE) GEL, DENTIFRICE TOPEX CHERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX MINT (BENZOCAINE) GEL, DENTIFRICE TOPEX BUBBLE GUM (BENZOCAINE) GEL, DENTIFRICE TOPEX STRAWBERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX RASPBERRY (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "SULTAN HEALTHCARE"]10Legacy NDC20250308_87083cc6-fedc-4676-84e1-3134f690dfa9.zip
0699-7031TOPEX PINA COLADA (BENZOCAINE) GEL, DENTIFRICE TOPEX CHERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX MINT (BENZOCAINE) GEL, DENTIFRICE TOPEX BUBBLE GUM (BENZOCAINE) GEL, DENTIFRICE TOPEX STRAWBERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX RASPBERRY (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "SULTAN HEALTHCARE"]10Legacy NDC20250308_87083cc6-fedc-4676-84e1-3134f690dfa9.zip
0699-7051TOPEX PINA COLADA (BENZOCAINE) GEL, DENTIFRICE TOPEX CHERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX MINT (BENZOCAINE) GEL, DENTIFRICE TOPEX BUBBLE GUM (BENZOCAINE) GEL, DENTIFRICE TOPEX STRAWBERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX RASPBERRY (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "SULTAN HEALTHCARE"]10Legacy NDC20250308_87083cc6-fedc-4676-84e1-3134f690dfa9.zip
0699-7061TOPEX PINA COLADA (BENZOCAINE) GEL, DENTIFRICE TOPEX CHERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX MINT (BENZOCAINE) GEL, DENTIFRICE TOPEX BUBBLE GUM (BENZOCAINE) GEL, DENTIFRICE TOPEX STRAWBERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX RASPBERRY (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "SULTAN HEALTHCARE"]10Legacy NDC20250308_87083cc6-fedc-4676-84e1-3134f690dfa9.zip
0699-7071TOPEX PINA COLADA (BENZOCAINE) GEL, DENTIFRICE TOPEX CHERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX MINT (BENZOCAINE) GEL, DENTIFRICE TOPEX BUBBLE GUM (BENZOCAINE) GEL, DENTIFRICE TOPEX STRAWBERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX RASPBERRY (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "SULTAN HEALTHCARE"]10Legacy NDC20250308_87083cc6-fedc-4676-84e1-3134f690dfa9.zip
0699-7081TOPEX PINA COLADA (BENZOCAINE) GEL, DENTIFRICE TOPEX CHERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX MINT (BENZOCAINE) GEL, DENTIFRICE TOPEX BUBBLE GUM (BENZOCAINE) GEL, DENTIFRICE TOPEX STRAWBERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX RASPBERRY (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "SULTAN HEALTHCARE"]10Legacy NDC20250308_87083cc6-fedc-4676-84e1-3134f690dfa9.zip
0699-7091TOPEX PINA COLADA (BENZOCAINE) GEL, DENTIFRICE TOPEX CHERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX MINT (BENZOCAINE) GEL, DENTIFRICE TOPEX BUBBLE GUM (BENZOCAINE) GEL, DENTIFRICE TOPEX STRAWBERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX RASPBERRY (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "SULTAN HEALTHCARE"]10Legacy NDC20250308_87083cc6-fedc-4676-84e1-3134f690dfa9.zip
0699-7100TOPEX PINA COLADA (BENZOCAINE) GEL, DENTIFRICE TOPEX CHERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX MINT (BENZOCAINE) GEL, DENTIFRICE TOPEX BUBBLE GUM (BENZOCAINE) GEL, DENTIFRICE TOPEX STRAWBERRY (BENZOCAINE) GEL, DENTIFRICE TOPEX RASPBERRY (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "SULTAN HEALTHCARE"]10Legacy NDC20250308_87083cc6-fedc-4676-84e1-3134f690dfa9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW51
BenzocaineACTIVE MOIETYU3RSY48JW51

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0699-70010699-7001-34
0699-70110699-7011-34
0699-70210699-7021-34
0699-70310699-7031-34
0699-70510699-7051-34
0699-70610699-7061-34
0699-70710699-7071-01
0699-70810699-7081-01
0699-70910699-7091-01
0699-71000699-7100-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 60 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
BENZOCAINEU3RSY48JW5ACTIB
FD&C RED NO. 40WZB9127XOAIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
BENZOCAINEU3RSY48JW5ACTIB
D&C GREEN NO. 58J6RDU8L9XIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
PEPPERMINT OILAV092KU4JHIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
BENZOCAINEU3RSY48JW5ACTIB
D&C RED NO. 28767IP0Y5NHIACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
BENZOCAINEU3RSY48JW5ACTIB
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C RED NO. 40WZB9127XOAIACT
BENZOCAINEU3RSY48JW5ACTIB
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C RED NO. 40WZB9127XOAIACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
BENZOCAINEU3RSY48JW5ACTIB
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
aebb646a-c435-4892-954d-45ad150fdaac87083cc6-fedc-4676-84e1-3134f690dfa92025-12-11WarningsExact identifier
spl set id: 87083cc6-fedc-4676-84e1-3134f690dfa9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.