Listerine Fluoride Defense Anticavity mint Shield

Manufacturer: Johnson & Johnson Consumer Inc.
Effective date: 2020-04-30
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 23:32:40

Label at a glance#

ProductListerine Fluoride Defense Anticavity mint Shield

Active ingredientSodium Fluoride

Label structure11 sections

Dosage and administration

Adults and children 12 years of age and older: use twice daily after brushing your teeth with a toothpaste vigorously swish 10 ml (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing supervise children as necessary until capable of using without supervision Children under 12 years of age: consult a dentist or doctor

Storage and handling

store at controlled room temperature 20° - 25°C (68° - 77°F) cold weather may temporarily cloud this product

Contacts and useful links#

PhoneLabel contact1-888-222-0182

PhoneLabel contact215-273-8755

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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:
- use twice daily after brushing your teeth with a toothpaste
- vigorously swish 10 ml (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
- do not swallow the rinse
- do not eat or drink for 30 minutes after rinsing
- supervise children as necessary until capable of using without supervision
Children under 12 years of age: consult a dentist or doctor

Other information

STORAGE AND HANDLING SECTION

store at controlled room temperature 20° - 25°C (68° - 77°F)
cold weather may temporarily cloud this product

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol solution, alcohol (21.6%), poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphoric acid, sucralose, menthol, disodium phosphate, FD&C blue no. 1

Questions?

OTC - QUESTIONS SECTION

Call toll-free 1-888-222-0182 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Dist: Johnson & Johnson Healthcare Products
Division of McNEIL-PPC, Inc.
Skillman, NJ 08558-9418 USA

PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LISTERINE^®
FLUORIDE
DEFENSE™
ANTICAVITY MOUTHWASH

SODIUM FLUORIDE & ACIDULATD PHOSPHATE TOPICAL SOLUTION
Shields Teeth from
Cavity Causing Acids,
Rebuilds Minerals &
Strengthens Enamel

IMPORTANT: Read directions
for proper use.
Replaces LISTERINE^® Restoring

FROM THE #1 DENTIST RECOMMENDED BRAND*
#1

MINT SHIELD^®

Principal Display Panel - 1.0 L Bottle Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	1
Eucalyptol	INACTIVE INGREDIENT	RV6J6604TK	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
Menthol	INACTIVE INGREDIENT	L7T10EIP3A	1
Methyl Salicylate	INACTIVE INGREDIENT	LAV5U5022Y	1
Phosphoric Acid	INACTIVE INGREDIENT	E4GA8884NN	1
Poloxamer 407	INACTIVE INGREDIENT	TUF2IVW3M2	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	1
Sodium Phosphate, Dibasic, Anhydrous	INACTIVE INGREDIENT	22ADO53M6F	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1
Sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	1
Thymol	INACTIVE INGREDIENT	3J50XA376E	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Listerine Fluoride Defense Anticavity mint Shield
Sodium Fluoride
Fluoride Ion
Water
Sorbitol
Alcohol
Poloxamer 407
Sodium Lauryl Sulfate
Eucalyptol
Methyl Salicylate
Thymol
Phosphoric Acid
Sucralose
Menthol, Unspecified Form
Sodium Phosphate, Dibasic, Anhydrous
FD&C Blue No. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42002-450	42002-450-71

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Sodium Fluoride	8ZYQ1474W7	ACTIM
Water	059QF0KO0R	IACT
Sorbitol	506T60A25R	IACT
Alcohol	3K9958V90M	IACT
Poloxamer 407	TUF2IVW3M2	IACT
Sodium Lauryl Sulfate	368GB5141J	IACT
Eucalyptol	RV6J6604TK	IACT
Methyl Salicylate	LAV5U5022Y	IACT
Thymol	3J50XA376E	IACT
Phosphoric Acid	E4GA8884NN	IACT
Sucralose	96K6UQ3ZD4	IACT
Menthol, Unspecified Form	L7T10EIP3A	IACT
Sodium Phosphate, Dibasic, Anhydrous	22ADO53M6F	IACT
FD&C Blue No. 1	H3R47K3TBD	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 6 · 336 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		1751 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / ORAL		19 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	LOTION / TOPICAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	SPRAY / NASAL		2 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SYRUP / ORAL		70 mg	Exact identifier — unii candidate 48 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
Menthol	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Menthol	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Methyl Salicylate	METHYL SALICYLATE	LAV5U5022Y	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
Menthol	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TABLET, EXTENDED RELEASE / ORAL		210 mg	Exact identifier — unii candidate 48 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	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION, EXTENDED RELEASE / ORAL	0.08 mg/1ml		Exact identifier — unii candidate 42 equally ranked IID candidates
Eucalyptol	EUCALYPTOL	RV6J6604TK	DROPS / NASAL	0.2 mg/1ml		Exact identifier — unii candidate 7 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	SPONGE / TOPICAL	5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Eucalyptol	EUCALYPTOL	RV6J6604TK	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	GEL / DENTAL	1.47 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Poloxamer 407	POLOXAMER 407	TUF2IVW3M2	SOLUTION / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Menthol	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	FILM / ORAL		1 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	LOTION / TOPICAL		111 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
Menthol	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	SHAMPOO / TOPICAL	65 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED PELLETS / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, FOR SUSPENSION / ORAL		65 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
Menthol	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / ORAL		140 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Eucalyptol	EUCALYPTOL	RV6J6604TK	PASTE, DENTIFRICE / DENTAL	2.4 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	INSERT / VAGINAL		15 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CREAM / VAGINAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	GRANULE, FOR SUSPENSION / ORAL		23 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 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
29ca0cf1-8803-4f4d-b773-a4635bd36e24			8dba8f97-c415-4f40-bdd8-f7d253ea57c7	2020-04-30	Warnings	Exact identifier spl id: 29ca0cf1-8803-4f4d-b773-a4635bd36e24 spl set id: 8dba8f97-c415-4f40-bdd8-f7d253ea57c7

Reported adverse events (FAERS/openFDA)#

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