LISTERINE HEALTHY WHITE RESTORING ANTICAVITY FLUORIDE CLEAN MINT- sodium fluoride mouthwash

Listerine Healthy White Restoring Anticavity Fluoride Clean Mint by

Drug Labeling and Warnings

Listerine Healthy White Restoring Anticavity Fluoride Clean Mint 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 prevention of dental cavities

Warnings

Stop use and ask 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 a day 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, alcohol (10.5% v/v), sorbitol, hydrogen peroxide, PEG-40 hydrogenated castor oil, poloxamer 407, sodium saccharin, menthol, flavor, phosphoric acid, disodium phosphate, sucralose

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 - 946 mL Bottle Label

ANTICAVITY FLUORIDE MOUTHWASH
LISTERINE®
HEALTHY WHITE®
RESTORING
SODIUM FLUORIDE &
ACIDULATED PHOSPHATE TOPICAL SOLUTION
IMPORTANT: READ DIRECTIONS FOR PROPER USE
FOR A HEALTHIER
MOUTH
*vs brushing alone
in a lab study
CLEAN MINT
946mL (32 Fl Oz)

INGREDIENTS AND APPEARANCE

LISTERINE HEALTHY WHITE RESTORING ANTICAVITY FLUORIDE CLEAN MINT 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0500
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)
Alcohol (UNII: 3K9958V90M)
Sorbitol (UNII: 506T60A25R)
Hydrogen Peroxide (UNII: BBX060AN9V)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
Poloxamer 407 (UNII: TUF2IVW3M2)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Phosphoric Acid (UNII: E4GA8884NN)
Sucralose (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0500-1	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2010
2	NDC: 69968-0500-2	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	01/01/2010

Labeler - Johnson & Johnson Consumer Inc. (002347102)