LISTERINE TOTAL CARE KIDS ANTICAVITY FLUORIDE RINSE MINT SHIELD- sodium fluoride mouthwash

Listerine Total Care Kids Anticavity Fluoride Rinse Mint Shield by

Drug Labeling and Warnings

Listerine Total Care Kids Anticavity Fluoride Rinse Mint Shield by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

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

Other information

• Store at room temperature
• Cold weather may temporarily cloud this product

Inactive ingredients

Water, Sorbitol, Sucralose, Phosphoric Acid, Cetylpyridinium Chloride, Menthol, Disodium Phosphate, Flavor, Yellow 6, Blue 1

Questions?

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

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Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

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*

MINT

SHEILD

KID-APPROVED

TASTE

500 mL (16.9Fl Oz)

IMPORTANT: Read

directions for proper use.

INGREDIENTS AND APPEARANCE

LISTERINE TOTAL CARE KIDS ANTICAVITY FLUORIDE RINSE MINT SHIELD 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0902
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PHOSPHORIC ACID (UNII: E4GA8884NN)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0902-5	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	12/11/2024

Labeler - Kenvue Brands LLC (118772437)