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Topex (Gelato Anesthetic, Benzo-Jel) Package Insert

Status:
Prescription (Rx) Facts
Strength:
220 mg/g
Brand names:
  • Gelato Anesthetic
  • Benzo-Jel
Active ingredient:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Topex

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. 1. Each gram of Topex 20% benzocaine gel or liquid contains between 180-220mg benzocaine in a flavored base.
  2. 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. 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. 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)

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Topex

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Benzocaine 220 mg/g
Dosage form Gel, dentifrice
Route Dental
Marketing status not in the current FDA NDC Directory
Company (applicant) DENTSPLY Caulk
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 2 labelers list this drug on DailyMed
Packages (NDC)
Package
220 mg/g – 100 g in 1 jar NDC 10216-3071-1
220 mg/g – 100 g in 1 jar NDC 10216-3081-1
220 mg/g – 100 g in 1 jar NDC 10216-3091-1
220 mg/g – 100 g in 1 jar NDC 10216-3110-1

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.