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Topical Anesthetic (Gelato Anesthetic) Package Insert

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

Prescribing information (package insert) - Topical Anesthetic

Gel – 1oz/34g

2731001 Cherry

2731002 Mint

2731004 Pina Colada

2731005 Bubble Gum

2731006 Strawberry

2731007 Raspberry

For dental use only

Rx only

1. INDICATIONS AND USAGE

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.

2. 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.

3. DOSAGE FORMS AND STRENGTH

Each gram of 20% Benzocaine Gel contains between 180-220 mg benzocaine in a flavored base.

4. CONTRAINDICATIONS

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

5. WARNINGS AND PRECAUTIONS

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 bottle by reintroducing a used cotton applicator into the bottle

6. OVERDOSAGE

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

7. DESCRIPTION

Flavored 20% benzocaine gel for topical mucosa anesthesia

8. HOW SUPPLIED/STORAGE AND HANDLING

20% benzocaine gel is supplied in multiple use containers

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

For more information call NDC at 1-800-929-4232

Manufactured for NDC Nashville, TN 37217

Made in the USA

2731001DF, R1-120116

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 Topical Anesthetic

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) NDC, Inc.
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
220 mg/g – 34 g in 1 jar NDC 43128-021-30
220 mg/g – 34 g in 1 jar NDC 43128-023-30
220 mg/g – 34 g in 1 jar NDC 43128-024-30
220 mg/g – 34 g in 1 jar NDC 43128-022-30
220 mg/g – 34 g in 1 jar NDC 43128-020-30
220 mg/g – 34 g in 1 jar NDC 43128-026-30

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.