LISTERINE TOTAL CARE EXTRA MILD ALCOHOL FREE ANTICAVITY FLUORIDE MOUTHWASH- sodium fluoride mouthwash

Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash by

Drug Labeling and Warnings

Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash 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

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 daily 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

Inactive Ingredients

Water, Sorbitol, Propylene Glycol, Sodium Lauryl Sulfate, Poloxamer 407, Sodium Benzoate, Phosphoric Acid, Eucalyptol, Methyl Salicylate, Thymol,Sodium Saccharin, Menthol, Sucralose, Disodium Phosphate, Flavor

Questions?

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

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC

Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label

ANTICAVITY FLUORIDE MOUTHWASH

LISTERINE ®

TOTAL CARE

POWERED BY ESSENTIAL OILS + FLUROIDE

6

IN 1

FOR A HEALTHIER MOUTH

360

CLEAN*

FRESHENS

BREATH

KILLS 99.9%

OF GERMS*

REPAIRS

ENAMEL

24 HR CAVITY

PROTECTION †

STRENGTHENS

TEETH

IMPORTANT: READ DIRECTIONS FOR PROPER USE

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

1.0 L (1 Qt 1.8 FL Oz)

INGREDIENTS AND APPEARANCE

LISTERINE TOTAL CARE EXTRA MILD ALCOHOL FREE ANTICAVITY FLUORIDE MOUTHWASH 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0950
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)
EUCALYPTOL (UNII: RV6J6604TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHOSPHORIC ACID (UNII: E4GA8884NN)
METHYL SALICYLATE (UNII: LAV5U5022Y)
THYMOL (UNII: 3J50XA376E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MENTHOL (UNII: L7T10EIP3A)
DISODIUM PHOSPHATE (UNII: 22ADO53M6F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0950-1	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2026
2	NDC: 69968-0950-5	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2026
3	NDC: 69968-0950-2	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	02/01/2026

Labeler - Kenvue Brands LLC (118772437)