FDA.reportPublic FDA data

Gelato Topical Anesthetic

Manufacturer
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | Keystone Industries
Effective date
2024-04-11
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:47:39

Label at a glance#

ProductGelato Topical Anesthetic
Active ingredientBENZOCAINE
Label structure10 sections

Indications and uses

For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures. For Professional Use Only.

Dosage and administration

Apply only amount needed to the oral mucosa to prevent or relieve pain. Children under 2 years of age: do not use

Storage and handling

Store at room temperature. Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.
  • For Professional Use Only.

Warnings

WARNINGS SECTION

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child 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

Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Flammable. Do not use near fire or flame. Avoid smoking during use.

Do not use

  • for teething
  • in children under 2 years of age

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply only amount needed to the oral mucosa to prevent or relieve pain.

  • Children under 2 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

Store at room temperature. Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ethyl Alcohol, Flavor, Polyethylene Glycol, Sodium Saccharin, Hydrocarbon Propellant (Isobutane and propane).

Questions or comments?

OTC - QUESTIONS SECTION

1-800-333-3131

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

front box labelfront box label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1435490benzocaine 20 % Oral SprayPSN7
1435495Gelato Anesthetic 20 % Oral SprayPSN7
1435495benzocaine 200 MG/ML Oral Spray [Gelato Anesthetic]SBD7
1435490benzocaine 200 MG/ML Oral SpraySCD7
1435490benzocaine 20 % Oral SpraySY7
1435495Gelato Anesthetic 20 % Oral SpraySY7
1435495Gelato Anesthetic 200 MG/ML Oral SpraySY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68400-323-352024-12-19C16284748780-11030e364-fcc0-111a-e063-dadaa90a10e29991de96-99a1-42f0-9ddd-e530ca9ceab1
68400-323-352024-01-30C16284748780-11030e364-fcc0-111a-e063-dadaa90a10e29991de96-99a1-42f0-9ddd-e530ca9ceab1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68400-323-35Gelato Topical Anesthetic57 g in 1 BOTTLE, SPRAYSPRAY, METERED577

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68400-323GELATO TOPICAL ANESTHETIC (BENZOCAINE) SPRAY, METERED [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]7Current NDC, Legacy NDC, 1 package rows20241222_9991de96-99a1-42f0-9ddd-e530ca9ceab1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW52
BENZOCAINEACTIVE MOIETYU3RSY48JW52
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68400-32368400-323-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ALCOHOL3K9958V90MIACT
ISOBUTANEBXR49TP611IACT
PROPANET75W9911L6IACT
BENZOCAINEU3RSY48JW5ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / DENTALNAExact identifier — unii+route
10 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii+route
10 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / DENTALNAExact identifier — unii+route
10 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii+route
10 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSPRAY, METERED / NASAL320 mgExact identifier — unii+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSPRAY, METERED / NASAL320 mgExact identifier — unii+dosage form
2 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / DENTAL0.05 %w/vExact identifier — unii+route
10 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / DENTAL0.05 %w/vExact identifier — unii+route
10 equally ranked IID candidates

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
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc9991de96-99a1-42f0-9ddd-e530ca9ceab12024-04-11WarningsExact identifier
ndc (package): 68400-323-35
ndc (product): 68400-323
ndc11 (package): 68400032335
spl id: 15d7eb39-c284-291a-e063-6294a90adc6a
spl set id: 9991de96-99a1-42f0-9ddd-e530ca9ceab1

Reported adverse events (FAERS/openFDA)#

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