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 daily after brushing your teeth with a toothpaste
- vigorously swish 10mL (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 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, 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)

Dist: Johnson & Johnson Healthcare Products
Division of McNEIL-PPC, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

ANTICAVITY FLOURIDE MOUTHWASH

LISTERINE ®

TOTAL CARE

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

SODIUM FLUORIDE &

ACIDULATED PHOSPHATE TOPICAL SOLUTION

6 IN 1

BENEFITS

HELPS PREVENT CAVITIES
RESTORES ENAMEL
STRENGTHENS TEETH
KILLS BAD BREATH GERMS
CLEANS THE WHOLE MOUTH
FRESHENS BREATH

500 mL (16.9 Fl Oz) FRESH MINT

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

LISTERINE TOTAL CARE FRESH MINT ANTICAVITY
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0178
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69968-0178-3	95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2009
2	NDC:69968-0178-1	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2009	08/28/2023
3	NDC:69968-0178-2	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2009
4	NDC:69968-0178-4	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2009
5	NDC:69968-0178-5	2 in 1 PACKAGE	11/01/2009
5		1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6	NDC:69968-0178-6	3 in 1 PACKAGE	11/01/2009
6		1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	11/01/2009

Labeler - Johnson & Johnson Consumer Inc. (118772437)

LISTERINE ® TOTAL CARE ANTICAVITY MOUTHWASH FRESH MINT