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...
Store between 59°-86°F (15°-30°C). Protect from freezing.
www.sultanhealthcare.comDIRECTIONS 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.
Flavored 20% benzocaine gel or liquid for topical mucosal anesthesia.
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.
Should not be used with individuals with a known sensitivity to benzocaine or PABA.
Keep out of reach of children. For professional dental use only.
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.
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)
NPN 00638358
TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)
CHERRY
Net Content 100g
NPN 00638358
TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)
MINT
Net Content 100g
NPN 00638358
TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)
PIÑA COLADA
Net Content 100g
NPN 00638358
TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)
BUBBLE NUM®
Net Content 100g
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10216-3071-1 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c43e-621f-e053-dbdaa90a74ad | Topex ® Topical Anesthetic Gel/Liquid – 20% Benzocaine |
| 10216-3081-1 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c43e-621f-e053-dbdaa90a74ad | Topex ® Topical Anesthetic Gel/Liquid – 20% Benzocaine |
| 10216-3091-1 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c43e-621f-e053-dbdaa90a74ad | Topex ® Topical Anesthetic Gel/Liquid – 20% Benzocaine |
| 10216-3110-1 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c43e-621f-e053-dbdaa90a74ad | Topex ® Topical Anesthetic Gel/Liquid – 20% Benzocaine |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10216-3071-1 | Topex | 100 g in 1 JAR | GEL, DENTIFRICE | 100 | 1 | |
| 10216-3081-1 | Topex | 100 g in 1 JAR | GEL, DENTIFRICE | 100 | 1 | |
| 10216-3091-1 | Topex | 100 g in 1 JAR | GEL, DENTIFRICE | 100 | 1 | |
| 10216-3110-1 | Topex | 100 g in 1 JAR | GEL, DENTIFRICE | 100 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10216-3071 | TOPEX (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY CAULK] | 1 | Legacy NDC, 1 package rows | 20100719_db4f2105-9e47-45b6-b550-6397708eb335.zip |
| 10216-3081 | TOPEX (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY CAULK] | 1 | Legacy NDC, 1 package rows | 20100719_db4f2105-9e47-45b6-b550-6397708eb335.zip |
| 10216-3091 | TOPEX (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY CAULK] | 1 | Legacy NDC, 1 package rows | 20100719_db4f2105-9e47-45b6-b550-6397708eb335.zip |
| 10216-3110 | TOPEX (BENZOCAINE) GEL, DENTIFRICE [DENTSPLY CAULK] | 1 | Legacy NDC, 1 package rows | 20100719_db4f2105-9e47-45b6-b550-6397708eb335.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Benzocaine | ACTIVE INGREDIENT | U3RSY48JW5 | 1 | |
| Benzocaine | ACTIVE MOIETY | U3RSY48JW5 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 10216-3071 | 10216-3071-1 |
| 10216-3081 | 10216-3081-1 |
| 10216-3091 | 10216-3091-1 |
| 10216-3110 | 10216-3110-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Benzocaine | U3RSY48JW5 | ACTIB |
| Benzocaine | U3RSY48JW5 | ACTIB |
| Benzocaine | U3RSY48JW5 | ACTIB |
| Benzocaine | U3RSY48JW5 | ACTIB |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 983a1364-6118-4d7e-9b80-5011306c0b7d | db4f2105-9e47-45b6-b550-6397708eb335 | 2010-03-05 | Warnings, Adverse reactions | db4f2105-9e47-45b6-b550-6397708eb335 |
Adverse event summaries are temporarily unavailable. Other product information remains available.