Mouth Sore Medication

Manufacturer: Zee Medical | Safetec of America, Inc.
Effective date: 2014-06-23
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:41:36

Label at a glance#

ProductMouth Sore Medication

Active ingredientbenzocaine

Label structure12 sections

Indications and uses

temporarily relieves pain caused by toothache canker sores gum sores dental work cheek bites denture irritation minor irritation or injury of the mouth and gums

Dosage and administration

adults and children 2 years and older: dry affected area and apply medication. Use up to 4 times daily, but not more than every 2 hours, or as directed by a dentist or doctor. children under 12 years of age should be supervised in the use of this product children under 2 years of age: ask a dentist or doctor

Contacts and useful links#

PhoneLabel contact1-800-841-8417

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

COMPARE TO THE ACTIVE INGREDIENT IN KANK-A^®

ZEE MOUTH SORE MEDICATION

ORAL PAIN RELIEVER

Fast Mouth Sore Relief

Canker sores
Gum Pain
Toothache
Dental Work

25 Packets

0.5g (0.017 oz) per packet

DO NOT USE IF PACKET IS TORN OR OPEN

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20% (w/w)

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain caused by

toothache
canker sores
gum sores
dental work
cheek bites
denture irritation
minor irritation or injury of the mouth and gums

Warnings

WARNINGS SECTION

For oral use only. Avoid contact with eyes.

SPL UNCLASSIFIED 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

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years and older: dry affected area and apply medication. Use up to 4 times daily, but not more than every 2 hours, or as directed by a dentist or doctor.
children under 12 years of age should be supervised in the use of this product
children under 2 years of age: ask a dentist or doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

Questions?

OTC - QUESTIONS SECTION

1-800-841-8417

Distributed by
Zee Medical, Inc., Irvine,CA 92606
This product is not manufactured or distributed by Blistex, Inc., distributor of KANK-A^® Mouth Pain Liquid

PRINCIPAL DISPLAY PANEL – packet label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DO NOT USE IF PACKET IS TORN OR OPEN

MOUTH SORE ZEE

MEDICATION

Oral Pain Reliever

Fast Mouth Sore Relief

Canker sores
Gum Pain
Toothache
Dental Work

5g (0.017 oz)

PRINCIPAL DISPLAY PANEL – Carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 35418-631-01

COMPARE TO THE ACTIVE INGREDIENT IN KANK-A^®*

ZEE MOUTH SORE MEDICATION

ORAL PAIN RELIEVER

Fast Mouth Sore Relief

Canker sores
Gum Pain
Toothache
Dental Work

25 Packets

0.5g (0.017 oz) per packet

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
35418-631-01	2020-01-31	C162847	48780-1	9d75b9cf-d6b2-f424-e053-dadaa90a57ce	2666b95e-667f-471a-9929-9deca27e9cbc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
35418-631-01	Mouth Sore Medication	0.5 g in 1 PACKET	LIQUID	0.5		2
35418-631-01	Mouth Sore Medication	25 in 1 BOX	LIQUID	25		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35418-631	MOUTH SORE MEDICATION (BENZOCAINE) LIQUID [ZEE MEDICAL]	2	Legacy NDC, 2 package rows	20150204_2666b95e-667f-471a-9929-9deca27e9cbc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	2
benzocaine	ACTIVE MOIETY	U3RSY48JW5	2
peppermint oil	INACTIVE INGREDIENT	AV092KU4JH	2
polyethylene glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	2
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	2
saccharin sodium dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	2
sorbic acid	INACTIVE INGREDIENT	X045WJ989B	2

Products#

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

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

Mouth Sore Medication
benzocaine
polyethylene glycol 400
polyethylene glycol 3350
peppermint oil
saccharin sodium dihydrate
sorbic acid

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
35418-631	35418-631-01

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
polyethylene glycol 3350	G2M7P15E5P	IACT
peppermint oil	AV092KU4JH	IACT
saccharin sodium dihydrate	SB8ZUX40TY	IACT
sorbic acid	X045WJ989B	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 3 · 138 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	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	SOLUTION / ORAL		53 mg	Exact identifier — unii candidate 21 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
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	SOLUTION / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 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 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, DELAYED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 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 dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	FILM / BUCCAL		12 mg	Exact identifier — unii candidate 21 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
sorbic acid	SORBIC ACID	X045WJ989B	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	SUSPENSION / ORAL	100 mg/1ml		Exact identifier — unii candidate 21 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
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		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
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	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	SOLUTION/ DROPS / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 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	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 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	AEROSOL, POWDER / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	SYRUP / ORAL		120 mg	Exact identifier — unii candidate 21 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	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	TABLET, CHEWABLE / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / ORAL		70200 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	POWDER / SUBLINGUAL		1 mg	Exact identifier — unii candidate 21 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 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / INTRASYNOVIAL		87 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
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 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	SOLUTION / RECTAL		665 mg	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 dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	SPRAY, METERED / SUBLINGUAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 19 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	INJECTION, SOLUTION / INTRAVENOUS		24186 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / VAGINAL		1250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	TABLET / ORAL		10 mg	Exact identifier — unii candidate 19 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
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 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
peppermint oil	PEPPERMINT OIL	AV092KU4JH	TABLET / ORAL		28 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SUSPENSION / SUBCUTANEOUS	2.88 %w/v		Exact identifier — unii candidate 28 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	INJECTION / INTRAMUSCULAR		406 mg	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
peppermint oil	PEPPERMINT OIL	AV092KU4JH	LOZENGE / ORAL		12 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / BUCCAL		526 mg	Exact identifier — unii candidate 21 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
peppermint oil	PEPPERMINT OIL	AV092KU4JH	PASTE, DENTIFRICE / DENTAL	49.3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	TABLET / SUBLINGUAL	0.15 mg		Exact identifier — unii candidate 21 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
c54dcee0-8b21-4856-8391-d8ce5b4d0b8e			2666b95e-667f-471a-9929-9deca27e9cbc	2014-06-23	Warnings	Exact identifier spl id: c54dcee0-8b21-4856-8391-d8ce5b4d0b8e spl set id: 2666b95e-667f-471a-9929-9deca27e9cbc

Reported adverse events (FAERS/openFDA)#

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