Listerine ®

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.1 mg)

Inactive Ingredients

Water Sorbitol Phosphoric Acid Sucralose Cetylpyridinium Chloride Sodium Phosphate, Dibasic, Anhydrous Saccharin Sodium Menthol, Unspecified Form Fd&c Blue No. 1 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-01-01

Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

Aids in the prevention of dental cavities

Section 42229-5

Drug Facts

Section 50565-1

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

Adults and children 6 years of age and older:
Use twice a day 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
Instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
Supervise children as necessary until capable of using without supervision
Children under 6 years of age: consult a dentist or doctor

Questions?

call toll-free 888-222-0182 or 215-273-8755 (collect).

Active Ingredient

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

Other Information

Store at room temperature
Cold weather may temporarily cloud this product

Inactive Ingredients

Water, Sorbitol, Flavor, Phosphoric Acid, Sucralose, Cetylpyridinium Chloride, Disodium Phosphate, Sodium Saccharin, Menthol, Blue , Green 3

Principal Display Panel 500 Ml Bottle Label

2X STRONGER TEETH FOR

BETTER CAVITY PROTECTION*

*with brushing, in a lab study

ALCOHOL FREE

ANTICAVITY FLUORIDE RINSE

LISTERINE ^®

SMART RiNSE ®

SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION

BUBBLE

BLAST

500 mL (16.9Fl Oz)

IMPORTANT: Read

directions for proper use.

Structured Label Content

Use

Aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Purpose

Anticavity

Directions

Adults and children 6 years of age and older:
Use twice a day 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
Instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
Supervise children as necessary until capable of using without supervision
Children under 6 years of age: consult a dentist or doctor

Questions?

call toll-free 888-222-0182 or 215-273-8755 (collect).

Active Ingredient (Active ingredient)

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

Other Information (Other information)

Store at room temperature
Cold weather may temporarily cloud this product

Inactive Ingredients (Inactive ingredients)

Water, Sorbitol, Flavor, Phosphoric Acid, Sucralose, Cetylpyridinium Chloride, Disodium Phosphate, Sodium Saccharin, Menthol, Blue , Green 3

Principal Display Panel 500 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label)

2X STRONGER TEETH FOR

BETTER CAVITY PROTECTION*

*with brushing, in a lab study

ALCOHOL FREE

ANTICAVITY FLUORIDE RINSE

LISTERINE ^®

SMART RiNSE ®

SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION

BUBBLE

BLAST

500 mL (16.9Fl Oz)

IMPORTANT: Read

directions for proper use.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHOSPHORIC ACID", "unii": "E4GA8884NN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYLPYRIDINIUM CHLORIDE", "unii": "D9OM4SK49P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C GREEN NO. 3", "unii": "3P3ONR6O1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Aids in the prevention of dental cavities", "42229-5": "Drug Facts", "50565-1": "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.", "Purpose": "Anticavity", "Directions": "Adults and children 6 years of age and older: Use twice a day 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 Instruct children under 12 years of age in good rinsing habits (to minimize swallowing) Supervise children as necessary until capable of using without supervision Children under 6 years of age: consult a dentist or doctor", "Questions?": "call toll-free 888-222-0182 or 215-273-8755 (collect).", "Active ingredient": "Sodium fluoride 0.02% (0.01% w/v fluoride ion)", "Other information": "Store at room temperature Cold weather may temporarily cloud this product", "Inactive ingredients": "Water, Sorbitol, Flavor, Phosphoric Acid, Sucralose, Cetylpyridinium Chloride, Disodium Phosphate, Sodium Saccharin, Menthol, Blue , Green 3", "PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label": "2X STRONGER TEETH FOR BETTER CAVITY PROTECTION* *with brushing, in a lab study ALCOHOL FREE ANTICAVITY FLUORIDE RINSE LISTERINE ® SMART RiNSE ® SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION BUBBLE BLAST 500 mL (16.9Fl Oz) IMPORTANT: Read directions for proper use."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information