Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash

SPL v2

SPL

SPL Set ID 28986d7f-3e9a-8dfb-e063-6394a90a731e

Route

ORAL

Published

Effective Date 2024-12-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.1 mg)

Inactive Ingredients

Sorbitol Water 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 Active Since 2024-12-11

Description

Drug Facts

Purpose

Anticavity

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 a 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, Cetylpyridinium Chloride, Sucralose, Sodium Saccharin, Disodium Phosphate, Red 33, Green 3

Principal Display Panel 500 Ml Bottle Label

ALCOHOL FREE

ADA

Accepted

American

Dental

Association ®

24-HR CAVITY

PROTECTION ^†

^†when used twice daily

kid-approved taste

ANTICAVITY FLUORIDE RINSE

LISTERINE®

TOTAL CARE KiDS

SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION

6IN1

BENEFITS*

BERRY

SPLASH

KID-APPROVED

TASTE

500mL(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 a 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, 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)

ALCOHOL FREE

ADA

Accepted

American

Dental

Association ®

24-HR CAVITY

PROTECTION ^†

^†when used twice daily

kid-approved taste

ANTICAVITY FLUORIDE RINSE

LISTERINE®

TOTAL CARE KiDS

SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION

6IN1

BENEFITS*

BERRY

SPLASH

KID-APPROVED

TASTE

500mL(16.9Fl Oz)

IMPORTANT: Read

directions for proper use.

Advanced Ingredient Data

[{"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHOSPHORIC ACID", "unii": "E4GA8884NN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYLPYRIDINIUM CHLORIDE", "unii": "D9OM4SK49P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "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 a 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, Cetylpyridinium Chloride, Sucralose, Sodium Saccharin, Disodium Phosphate, Red 33, Green 3", "PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label": "ALCOHOL FREE ADA Accepted American Dental Association ® 24-HR CAVITY PROTECTION † † when used twice daily kid-approved taste ANTICAVITY FLUORIDE RINSE LISTERINE® TOTAL CARE KiDS SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION 6IN1 BENEFITS* BERRY SPLASH KID-APPROVED TASTE 500mL(16.9Fl Oz) IMPORTANT: Read directions for proper use."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:37.857325 · Updated: 2026-03-14T23:11:19.831195