LISTERINE TOTAL CARE FRESH MINT ANTICAVITY FLUORIDE- sodium fluoride mouthwash

Listerine Total Care Fresh Mint Anticavity Fluoride by

Drug Labeling and Warnings

Listerine Total Care Fresh Mint Anticavity Fluoride by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. 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 12 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
  • supervise children as necessary until capable using without supervision
• Children under 12 years of age: consult a dentist or doctor

Other information

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

Inactive Ingredients

Water, Alcohol (21.6% v/v),Sorbitol, Poloxamer 407,Eucalyptol,Flavor,Methyl Salicylate,Menthol,Phosphoric Acid,Sodium Saccharin

Thymol,Disodium Phosphate, Sucralose, Red 40, Blue 1

Questions?

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

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label

ANTICAVITY FLUORIDE MOUTHWASH

LISTERINE®

TOTAL CARE

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

6 IN 1

BENEFITS

1. 24- HOUR CAVITY PROTECTION+

2. RESTORES ENAMEL

3. STRENGTHENS TEETH

4. FRESHENS BREATH

5. CLEANS THE 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 FRESH MINT ANTICAVITY FLUORIDE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0787
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)
ALCOHOL (UNII: 3K9958V90M)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0787-1	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/13/2023
2	NDC: 69968-0787-2	95 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/13/2023
3	NDC: 69968-0787-5	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/13/2023
4	NDC: 69968-0787-3	3 in 1 PACKAGE	01/13/2023
4		1000 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 69968-0787-4	2 in 1 PACKAGE	01/13/2023
5		1000 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/13/2023

Labeler - Kenvue Brands LLC (118772437)