LISTERINE HEALTHYWHITE RESTORING CLEAN MINT- sodium fluoride mouthwash

Listerine HealthyWhite Restoring Clean Mint by

Drug Labeling and Warnings

Listerine HealthyWhite Restoring 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 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 teaspoonfulls) 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 if age: consult a dentist of doctor

Other information

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

Inactive ingredients

water, alcohol (10.5%), sorbitol, hydrogen peroxide, PEG-40 hydrogenated castor oil, poloxamer 407, sodium saccharin, menthol, flavor, phosphoric acid, disodium phosphate, sucralose

Questions?

call toll-free 888-222-5545 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

LISTERINE®

HealthyWhite™

anticavity fluoride mouthwash
SODIUM FLOURIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION
RESTORING

• 2X Stronger Enamel*
  & Whiter Teeth
• Kills Bad Breath Germs

  CLEAN MINT

473 mL (16 Fl Oz)

IMPORTANT: READ DIRECTIONS FOR PROPER USE.
DO NOT USE IF PRINTED LISTERINE® BAND AROUND CAP IS BROKEN OR MISSING.

INGREDIENTS AND APPEARANCE

LISTERINE HEALTHYWHITE RESTORING CLEAN MINT 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42002-512
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	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)
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)
Sucralose (UNII: 96K6UQ3ZD4)
Menthol, Unspecified Form (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42002-512-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2010
2	NDC: 42002-512-32	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)