Gelato Topical Anesthetic

Manufacturer: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Effective date: 2013-11-19
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 20:17:31

Label at a glance#

ProductGelato Topical Anesthetic

Active ingredientBenzocaine

Label structure2 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

IFU available upon request.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gelato12gPinaColada

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
238910	benzocaine 20 % Oral Gel	PSN	2
727988	Gelato Anesthetic 20 % Oral Gel	PSN	2
727988	benzocaine 0.2 MG/MG Oral Gel [Gelato Anesthetic]	SBD	2
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	2
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	2
727988	Gelato Anesthetic 0.2 MG/MG Oral Gel	SY	2
727988	Gelato Anesthetic 20 % Dental Gel	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68400-504-25	2020-01-31	C162847	48780-1	9d75b9d0-2b81-f424-e053-dadaa90a57ce	2f764009-5405-4ff5-8223-12d2aedeb2ad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68400-504-25	Gelato Topical Anesthetic	12 g in 1 JAR	GEL	12		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68400-504	GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	2	1 package rows	20131207_2f764009-5405-4ff5-8223-12d2aedeb2ad.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	2
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	2
Polyethylene Glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	2
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	2
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	2

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Gelato Topical Anesthetic
Benzocaine
Polyethylene Glycol 400
Polyethylene Glycol 3350
Saccharin Sodium
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
FD&C RED NO. 3
FD&C RED NO. 40
FD&C BLUE NO. 1
FD&C GREEN NO. 3

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68400-504	68400-504-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Polyethylene Glycol 400	B697894SGQ	IACT
Polyethylene Glycol 3350	G2M7P15E5P	IACT
Saccharin Sodium	SB8ZUX40TY	IACT
Benzocaine	U3RSY48JW5	ACTIB
FD&C YELLOW NO. 5	I753WB2F1M	CNTM
FD&C YELLOW NO. 6	H77VEI93A8	CNTM
FD&C RED NO. 3	PN2ZH5LOQY	CNTM
FD&C RED NO. 40	WZB9127XOA	CNTM
FD&C BLUE NO. 1	H3R47K3TBD	CNTM
FD&C GREEN NO. 3	3P3ONR6O1S	CNTM

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 2 · 98 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / INTRALESIONAL		87 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION / INTRAVENOUS	0.5 ml		Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SUPPOSITORY / RECTAL		5704 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / INTRA-ARTICULAR		56 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SWAB / TOPICAL		5250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION, SOLUTION / INTRAVENOUS		24186 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUPPOSITORY / RECTAL	0.25 mg/mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPRAY, METERED / NASAL		320 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL		13440 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	AEROSOL, POWDER / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / ORAL		70200 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / SUBCUTANEOUS	2.88 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAMUSCULAR		406 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SYRUP / ORAL		740 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	CREAM / TOPICAL		396 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, CHEWABLE / ORAL	15 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION, SOLUTION / INTRAMUSCULAR	20.3 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SPRAY, METERED / NASAL		96 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, ORALLY DISINTEGRATING / ORAL	0.16 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CREAM / TOPICAL	10 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET / ORAL		52 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / SOFT TISSUE		87 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAVENOUS		28216 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION / INTRASYNOVIAL	3 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, DELAYED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CONCENTRATE / ORAL		3000 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, LIQUID FILLED / ORAL		1122 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	OINTMENT / TOPICAL		1950 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION / INTRA-ARTICULAR		56 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / VAGINAL		1250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	EMULSION / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii candidate 36 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
020d43fb-4205-4a31-b598-370f49496639			2f764009-5405-4ff5-8223-12d2aedeb2ad	2013-11-19		Exact identifier spl id: 020d43fb-4205-4a31-b598-370f49496639 spl set id: 2f764009-5405-4ff5-8223-12d2aedeb2ad

Reported adverse events (FAERS/openFDA)#

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