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
- 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)

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 PHOSPAHTE TOPICAL SOLUTION

ZERO ALCOHOL

6 IN 1

BENEFITS

24-HOUR CAVITY PROTECTION+
RESTORES ENAMEL
STRENGTHENS TEETH
FRESHENS BREATH
CLEANS WHOLE MOUTH
KILLS BAD BREATH GERMS

+when used twice daily *bad breath germs

1.0L (1 Qt 1.8 Fl Oz)

FRESH MINT

Listerine

LISTERINE TOTAL CARE ZERO ALCOHOL ANTICAVITY FRESH MINT
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0194
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)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
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
Packaging
1	NDC:69968-0194-2	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2012
2	NDC:69968-0194-9	95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2012
3	NDC:69968-0194-5	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2012
4	NDC:69968-0194-1	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	07/25/2012

Labeler - Johnson & Johnson Consumer Inc. (118772437)

LISTERINE ® TOTAL CARE ZERO ALCOHOL ANTICAVITY MOUTHWASH FRESH MINT