LISTERINE TOTAL CARE ALCOHOL FREE ANTICAVITY FLUORIDE MOUTHWASH FRESH MINT- sodium fluoride mouthwash

Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint by

Drug Labeling and Warnings

Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint 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 doctor

Other information

• store at room temperature
• cold weather may temporarily cloud this product

Inactive Ingredients

Water, Sorbitol, Propylene Glycol, Poloxamer 407, Sodium Lauryl Sulfate, Flavor, Sodium Benzoate, Phosphoric Acid, Eucalyptol, Methyl Salicylate, Thymol, Sodium Saccharin, Menthol, Disodium Phosphate, Sucralose, Red 40, 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 - 1000 mL Bottle Label

ALCOHOL FREE

24-HR CAVITY PROTECTION †

& KILLS 99.9% OF GERMS*

ANTICAVITY FLUORIDE MOUTHWASH

LISTERINE ®

TOTAL CARE

IMPORTANT: READ DIRECTIONS FOR PROPER USE

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

MILD TASTE

6 IN 1

BENEFITS

1. 24-HOUR CAVITY PROTECTION †

2. RESTORES ENAMEL

3. STRENGTHENS TEETH

4. FRESHENS BREATH

5. CLEANS WHOLE MOUTH

6. KILLS BAD BREATH GERMS

†when used twice daily *bad breath germs

FRESH MINT

1.0 L (1 Qt 1.8 Fl Oz)

INGREDIENTS AND APPEARANCE

LISTERINE TOTAL CARE ALCOHOL FREE ANTICAVITY FLUORIDE MOUTHWASH FRESH MINT 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0924
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 407 (UNII: TUF2IVW3M2)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
THYMOL (UNII: 3J50XA376E)
PHOSPHORIC ACID (UNII: E4GA8884NN)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0924-1	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/02/2025
2	NDC: 69968-0924-5	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/02/2025
3	NDC: 69968-0924-9	95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/02/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	03/02/2025

Labeler - Kenvue Brands LLC (118772437)