Antiseptic Mouth Rinse

Manufacturer: Cardinal Health | Vi-Jon, LLC
Effective date: 2021-04-22
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: legacy-cache
Hydrated at: 2026-08-01 22:45:55

Label at a glance#

ProductAntiseptic Mouth Rinse

Active ingredientEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL

Label structure13 sections

Dosage and administration

adults and children 12 years of age and older vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow children under 12 years of age consult a dentist or doctor this rinse is not intended to replace brushing or flossing

Contacts and useful links#

PhoneLabel contact1-800-200-6313

Websitewww.myleader.com

www.myleader.com

Label contents#

Full prescribing information#

active ingredients

OTC - ACTIVE INGREDIENT SECTION

Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%

Purpose

OTC - PURPOSE SECTION

Antigingivitis, Antiplaque

Use

INDICATIONS & USAGE SECTION

helps control plaque that leads to gingivitis

Warnings

WARNINGS SECTION

for this product

Do not use

OTC - DO NOT USE SECTION

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

Stop use and ask a dentist if

OTC - STOP USE SECTION

gingivitis, bleeding, or redness persists for more than 2 weeks

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing 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 vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

children under 12 years of age consult a dentist or doctor

this rinse is not intended to replace brushing or flossing

Other information

SPL UNCLASSIFIED SECTION

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).

inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

disclaimer

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine

Adverse Reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

CN4246226 www.myleader.com 1-800-200-6313

318.003/318AH

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37205-318-98

Sealed With Printed Neckband For Your Protection

LEADER

Compare to

Listerine

Active ingredients

Antiseptic

Mouth Rinse

Original

Kills germs tat cause Bad Breath,

Plaque & the gum disease Gingivitis

16.9 FL OZ (500 mL)

image description

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1043619	Eucalyptol/Menthol/Methyl salicylate/Thymol (Mouthwash)	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD Active

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
EUCALYPTOL	ACTIVE INGREDIENT	RV6J6604TK	3
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	3
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	3
THYMOL	ACTIVE INGREDIENT	3J50XA376E	3
EUCALYPTOL	ACTIVE MOIETY	RV6J6604TK	3
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	3
METHYL SALICYLATE	ACTIVE MOIETY	LAV5U5022Y	3
THYMOL	ACTIVE MOIETY	3J50XA376E	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	3
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	3
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	3
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Antiseptic Mouth Rinse
EUCALYPTOL, Menthol, Methyl salicylate, thymol
EUCALYPTOL
MENTHOL
METHYL SALICYLATE
SALICYLIC ACID
THYMOL
WATER
ALCOHOL
BENZOIC ACID
POLOXAMER 407
SODIUM BENZOATE
CARAMEL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37205-318	37205-318-77, 37205-318-86

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
EUCALYPTOL	RV6J6604TK	ACTIB
MENTHOL	L7T10EIP3A	ACTIB
METHYL SALICYLATE	LAV5U5022Y	ACTIB
THYMOL	3J50XA376E	ACTIB
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
CARAMEL	T9D99G2B1R	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 · 141 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	CAPSULE / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION, SOLUTION / INTRAMUSCULAR	4.8 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	GEL / OPHTHALMIC		1 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CREAM / TOPICAL		13 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	POWDER, FOR SUSPENSION / ORAL	0.01 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SOLUTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CONCENTRATE / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 23 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	SYRUP / ORAL	207 mg/5ml		Exact identifier — unii candidate 9 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	SOLUTION / ORAL		11 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAMUSCULAR		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	GRANULE, FOR SUSPENSION / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 9 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	CREAM / TOPICAL	0.26 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SOLUTION / ORAL	50 mg/5ml		Exact identifier — unii candidate 15 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, DELAYED RELEASE / ORAL	0.34 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	LOTION / TOPICAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SUPPOSITORY / VAGINAL	2 mg		Exact identifier — unii candidate 23 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 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
e1e28754-43d3-42a5-b4b0-163ff04074b3			0d0f8ce6-281a-44d8-8265-21738bcfdaf4	2021-06-29	Warnings, Adverse reactions	Exact identifier spl set id: 0d0f8ce6-281a-44d8-8265-21738bcfdaf4

Reported adverse events (FAERS/openFDA)#

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