Listerine ®

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.1 mg)

Inactive Ingredients

Water Sorbitol Phosphoric Acid Cetylpyridinium Chloride Sucralose Saccharin Sodium Sodium Phosphate, Dibasic, Anhydrous D&c Red No. 33 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2020-01-06 Until 2022-09-08

Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

aids in 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
remove cap and hold bottle upright. Fill to 10 mL line by squeezing the front and back (not the sides) of the bottle. Stop squeezing. Excess liquid will drain back into the bottle. Pour in the cup.
vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
replace cap promptly after use
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). www.listerine.com

Active Ingredient

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

Other Information

store at room temperature

Inactive Ingredients

water, sorbitol, flavor, phosphoric acid, cetylpyridinium chloride, sucralose, sodium saccharin, disodium phosphate, red 33, green 3

Principal Display Panel 500 Ml Bottle Label

NEW!

2X STRONGER TEETH

FOR BETTER CAVITY PROTECTION*

ANTICAVITY FLUORIDE RINSE

LISTERINE ^®

SMART RiNSE _®

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

ALCOHOL FREE

*Versus brushing alone,

In a lab study.

IMPORTANT: Read

directions for proper use.

ADA

Accepted

American

Dental

Association ^®

BERRY

SLASH

500 mL (16.9 fl oz)

Structured Label Content

Use

aids in 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
remove cap and hold bottle upright. Fill to 10 mL line by squeezing the front and back (not the sides) of the bottle. Stop squeezing. Excess liquid will drain back into the bottle. Pour in the cup.
vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
replace cap promptly after use
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). www.listerine.com

Active Ingredient (Active ingredient)

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

Other Information (Other information)

store at room temperature

Inactive Ingredients (Inactive ingredients)

water, sorbitol, flavor, phosphoric acid, cetylpyridinium chloride, sucralose, sodium saccharin, disodium phosphate, red 33, green 3

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

NEW!

2X STRONGER TEETH

FOR BETTER CAVITY PROTECTION*

ANTICAVITY FLUORIDE RINSE

LISTERINE ^®

SMART RiNSE _®

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

ALCOHOL FREE

*Versus brushing alone,

In a lab study.

IMPORTANT: Read

directions for proper use.

ADA

Accepted

American

Dental

Association ^®

BERRY

SLASH

500 mL (16.9 fl oz)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "aids in 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 remove cap and hold bottle upright. Fill to 10 mL line by squeezing the front and back (not the sides) of the bottle. Stop squeezing. Excess liquid will drain back into the bottle. Pour in the cup. vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse replace cap promptly after use 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). www.listerine.com", "Active ingredient": "Sodium fluoride 0.02% (0.01% w/v fluoride ion)", "Other information": "store at room temperature", "Inactive ingredients": "water, sorbitol, flavor, phosphoric acid, cetylpyridinium chloride, sucralose, sodium saccharin, disodium phosphate, red 33, green 3", "PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label": "NEW! 2X STRONGER TEETH FOR BETTER CAVITY PROTECTION* ANTICAVITY FLUORIDE RINSE LISTERINE ® SMART RiNSE ® SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION ALCOHOL FREE *Versus brushing alone, In a lab study. IMPORTANT: Read directions for proper use. ADA Accepted American Dental Association ® BERRY SLASH 500 mL (16.9 fl oz)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information