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

Stop use and ask a dentist if oral irritation or tooth sensitivity occurs

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 of using without supervision
Children under 12 years of age: consult a dentist or doctor

Other information

protect from excessive heat (40°C/104°F)

Inactive ingredients

Water, Sorbitol, Alcohol (21.6% v/v), Hydrogen Peroxide, Poloxamer 407, Flavor, Sodium Saccharin, Sodium Lauryl Sulfate, Eucalyptol, Methyl Salicylate, Thymol, Phosphoric Acid, Menthol, Disodium Phosphate, Sucralose

Questions?

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

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

ANTICAVITY FLUORIDE MOUTHWASH

LISTERINE ®

TOTAL CARE
STAIN REMOVER
IMPORTANT: READ DIRECTIONS FOR PROPER USE
SODIUM FLUORIDE &
ACIDULATED PHOSPHATE TOPICAL SOLUTION

6 IN 1
BENEFITS
1.HELPS PREVENT CAVITIES
2.RESTORES ENAMEL
3.STRENGTHENS TEETH
4.KILLS BAD BREATH GERMS
5.CLEANS THE WHOLE MOUTH
6.FRESHENS BREATH

FRESH MINT

946 mL (32 Fl Oz)

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

LISTERINE TOTAL CARE STAIN REMOVER ANTICAVITY FLUORIDE FRESH MINT
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0537
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
ALCOHOL (UNII: 3K9958V90M)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLOXAMER 407 (UNII: TUF2IVW3M2)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
PHOSPHORIC ACID (UNII: E4GA8884NN)
EUCALYPTOL (UNII: RV6J6604TK)
THYMOL (UNII: 3J50XA376E)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SUCRALOSE (UNII: 96K6UQ3ZD4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0537-1	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2010
2	NDC:69968-0537-3	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2010	09/07/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	06/01/2010

Labeler - Johnson & Johnson Consumer Inc. (118772437)

Listerine ® Total Care Stain Remover Anticavity Fluoride Mouthwash Fresh Mint