Mark 3

Manufacturer: Cargus International, Inc. | Dharma Research, Inc.
Effective date: 2021-03-23
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:39:07

Label at a glance#

ProductMark 3

Active ingredientBENZOCAINE

Label structure10 sections

Indications and uses

For the temporary relief of pain associated with canker sores and minor dental procedures.

Dosage and administration

Adults and children 12 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of the product Children under 2 years of age: consult a dentist or doctor.

Contacts and useful links#

PhoneLabel contact1-888-732-2913

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 pain associated with canker sores and minor dental procedures.

Warnings

WARNINGS SECTION

Allergy alert Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "-caine" anesthetics.

Do not

OTC - DO NOT USE SECTION

use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.

Do not

OTC - DO NOT USE SECTION

exceed recommended dosage.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.

Children under 12 years of age should be supervised in the use of the product

Children under 2 years of age: consult a dentist or doctor.

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature 59 - 86°F (15 - 30°C). Protect from freezing and heat.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

FD&C Red No. 40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol

Distributed by

SPL UNCLASSIFIED SECTION

Mark 3, 135 North Rt. 9W, Congers, NY 10920

1-888-732-2913

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mark 3

Oral Anesthetic Gel

Bubble Gum

Gluten Free

with Vitamin E and Xylitol

NDC 61509-105-32

Net Wt. 1.12 oz. (32 g)

Distributed by Mark 3, 135 North Rt. 9W, Congers, NY 10920

Made in USA

20140303 105 Bubble Gum

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
61509-105-32	2023-01-30	C162847	48780-1	9855e2a2-47e8-60a7-e053-dbdaa90a05bd	8140f26f-2118-4f49-bca8-19b95a9e8009
61509-105-32	2021-03-23	C162847	48780-1	9855e2a2-47e8-60a7-e053-dbdaa90a05bd	8140f26f-2118-4f49-bca8-19b95a9e8009
61509-105-32	2019-11-27	C162847	48780-1	9855e2a2-47e8-60a7-e053-dbdaa90a05bd	8140f26f-2118-4f49-bca8-19b95a9e8009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61509-105-32	Mark 3	32 g in 1 BOTTLE	GEL	32		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61509-105	MARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]	2	Legacy NDC, 1 package rows	20210324_8140f26f-2118-4f49-bca8-19b95a9e8009.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Mark 3
Benzocaine
FD&C RED NO. 40
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 400
SACCHARIN SODIUM
.ALPHA.-TOCOPHEROL ACETATE
XYLITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61509-105	61509-105-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C RED NO. 40	WZB9127XOA	IACT
POLYETHYLENE GLYCOL 3350	G2M7P15E5P	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
XYLITOL	VCQ006KQ1E	IACT
BENZOCAINE	U3RSY48JW5	ACTIB

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 3 · 141 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	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 36 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	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 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
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, EXTENDED RELEASE / ORAL		61 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / INTRASYNOVIAL		87 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 12 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
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 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 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION/ DROPS / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / TOPICAL		6300 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	CAPSULE / ORAL		576 mg	Exact identifier — unii candidate 28 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
XYLITOL	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPONGE / TOPICAL	NA		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	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	GUM, CHEWING / BUCCAL		11915 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 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 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION, CONCENTRATE / ORAL		2813 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 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
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	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	SYRUP / ORAL		740 mg	Exact identifier — unii candidate 36 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
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		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
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION / INTRAMUSCULAR		56 mg	Exact identifier — unii candidate 28 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
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 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
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 28 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
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	GUM, CHEWING / BUCCAL		48 mg	Exact identifier — unii candidate 28 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	OINTMENT / TOPICAL		1950 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION / ORAL		1500 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, ORALLY DISINTEGRATING / ORAL		360 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 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
bd33b9b7-3c90-ffd1-e053-2995a90a961d			8140f26f-2118-4f49-bca8-19b95a9e8009	2021-03-23	Warnings	Exact identifier spl id: bd33b9b7-3c90-ffd1-e053-2995a90a961d spl set id: 8140f26f-2118-4f49-bca8-19b95a9e8009

Reported adverse events (FAERS/openFDA)#

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