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SmartPractice topical anesthetic gel 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) - SmartPractice topical anesthetic gel

DESCRIPTION

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

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 intra- oral radiographs.

CONTRAINDICATIONS

Should not be used with individuals with a known sensitivity to benzocaine or PABA.

WARNINGS

Keep out of reach of children. For professional dental use only.

PRECAUTIONS

SmartPractice 20% benzocaine gels are supplied in multiple use containers. Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle.

DOSAGE AND ADMINISTRATION

  1. 1. Each gram of benzocaine gel 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 gel into a dappen dish, then coat the scaler with the product prior to use.
  4. 4. Tightly re-cap the jar after each use.

STORAGE

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

DISTRIBUTED BY

distributed by:

SmartPractice

3400 east mcdowell rd

phoenix, AZ 85008

Made in USA.

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 SmartPractice topical anesthetic gel

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
Route Dental
Marketing status not in the current FDA NDC Directory
Company (applicant) SmartHealth, Inc. (DBA SmartPractice)
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
220 mg/g – 34 g in 1 bottle, plastic NDC 69521-041-34
220 mg/g – 34 g in 1 bottle, plastic NDC 69521-031-34
220 mg/g – 34 g in 1 bottle, plastic NDC 69521-051-34
220 mg/g – 34 g in 1 bottle, plastic NDC 69521-021-34
220 mg/g – 34 g in 1 bottle, plastic NDC 69521-011-34
220 mg/g – 34 g in 1 bottle, plastic NDC 69521-061-34

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.