SensiCaine Topical Anesthetic Gel Bubble Gum Flavor

Manufacturer: Safco Dental Supply Co.
Effective date: 2017-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:53:30

Label at a glance#

ProductTopical Anesthetic Bubble Gum

Active ingredientBenzocaine

Label structure7 sections

Contacts and useful links#

PhoneLabel contact800-621-2178

Websitewww.safcodental.com

www.safcodental.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

INGREDIENTS

INACTIVE INGREDIENT SECTION

Each gram of 20% benzocaine gel contains between 180-220 mg benzocaine U.S.P., in a water soluble base of PEG 3350 U.S.P., PEG 400 U.S.P., flavor, sodium saccharin U.S.P., and D&C Red #28.

USUAL DOSAGE

DOSAGE & ADMINISTRATION SECTION

For oral mucosal use only as directed by a dentist.

WARNING

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Do not use on people with known allergies to benzocaine and PABA compounds.

HOW SUPPLIED SECTION

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59-86°F (15-30°C).

INDICATIONS & USAGE SECTION

CAUTION

OTC - PURPOSE SECTION

Federal law prohibits dispensing without a prescription.

SPL UNCLASSIFIED SECTION

Distributed by:
Safco Dental Supply Co.
Buffalo Grove, IL 60089
800-621-2178
www.safcodental.com

PRINCIPAL DISPLAY PANEL - Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAFCO
SensiCaine

Topical Anesthetic Gel

Bubble Gum Flavor

Contains 20% Benzocaine

For Professional Use Only

1 oz. (34 g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
238910	benzocaine 20 % Oral Gel	PSN	2
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	2
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral 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
67239-0206-1	2020-01-31	C162847	48780-1	9d75b9d0-9b74-f424-e053-dadaa90a57ce	SensiCaine Topical Anesthetic Gel Bubble Gum Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67239-0206-1	Topical Anesthetic Bubble Gum	34 g in 1 JAR	GEL	34		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67239-0206	TOPICAL ANESTHETIC BUBBLE GUM (BENZOCAINE) GEL [SAFCO DENTAL SUPPLY CO.]	2	Legacy NDC, 1 package rows	20171217_d642b80f-a04e-497c-8f9f-6747bc08f7ad.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	1
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	1
Polyethylene Glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	1
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	1
Saccharin Sodium Dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Topical Anesthetic Bubble Gum
Benzocaine
Polyethylene Glycol 400
Saccharin Sodium
Polyethylene Glycol 3350
Water
D&C RED NO. 28

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67239-0206	67239-0206-1

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
Name	UNII	Kind
Benzocaine	U3RSY48JW5	ACTIB
Polyethylene Glycol 400	B697894SGQ	IACT
Saccharin Sodium	SB8ZUX40TY	IACT
Polyethylene Glycol 3350	G2M7P15E5P	IACT
Water	059QF0KO0R	IACT
D&C RED NO. 28	767IP0Y5NH	IACT

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 · 109 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / OPHTHALMIC		46 mg	Exact identifier — unii candidate 36 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 Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 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, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		60 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	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
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	OINTMENT / TOPICAL		1950 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	CAPSULE, EXTENDED RELEASE / ORAL		51 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	AEROSOL / TOPICAL	NA		Exact identifier — unii candidate 11 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
Saccharin Sodium Dihydrate	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 / INTRA-ARTICULAR		56 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, COATED / ORAL	0.5 mg		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 / INTRAMUSCULAR		56 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	Exact identifier — unii candidate 34 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	SOLUTION / ORAL		70200 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	TABLET / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium Dihydrate	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	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 11 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 Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	POWDER, FOR SUSPENSION / ORAL	0.7 mg/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	SUSPENSION / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
Saccharin Sodium Dihydrate	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	SOLUTION / TOPICAL		11100 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, EXTENDED RELEASE / ORAL		61 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	OINTMENT / TOPICAL		1179 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 11 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 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 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	SUSPENSION, EXTENDED RELEASE / ORAL		37 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	SOAP / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
Polyethylene Glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		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 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION / INTRAVENOUS	0.5 ml		Exact identifier — unii candidate 28 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 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 Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 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 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / INTRAMUSCULAR		87 mg	Exact identifier — unii candidate 28 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
7fa204a2-31c7-42bb-b68c-17166399864f			d642b80f-a04e-497c-8f9f-6747bc08f7ad	2017-12-17	Warnings	Exact identifier spl id: 7fa204a2-31c7-42bb-b68c-17166399864f spl set id: d642b80f-a04e-497c-8f9f-6747bc08f7ad

Reported adverse events (FAERS/openFDA)#

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