LISTERINE  TOTAL CARE PLUS WHITENING- sodium fluoride mouthwash 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Listerine Total Care Plus Whitening
FreshMint Flavor

Drug Facts

Active ingredient

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Purpose

Anticavity

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 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

  • store at controlled room temperature 20° - 25°C (68° - 77°F)
  • cold weather may temporarily cloud this product

Inactive ingredients

water, sorbitol solution, alcohol (21.6%), hydrogen peroxide, flavors, poloxamer 407, saccharin sodium, phosphoric acid, dibasic sodium phosphate, sodium lauryl sulfate, sucralose

Questions?

call 1-888-222-0182, weekdays

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

LISTERINE®
TOTAL CARE
PLUS WHITENING

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION
ANTICAVITY MOUTHWASH

  • NOTICEABLY WHITENS TEETH
  • HELPS PREVENT CAVITIES
  • RESTORES ENAMEL
  • STRENGTHENS TEETH
  • KILLS BAD BREATH GERMS
  • FRESHENS BREATH
  • FIGHTS UNSIGHTLY PLAQUE
    ABOVE THE GUM LINE

IMPORTANT: Read directions for proper use.
Do not use if printed band around cap is broken or missing.

FRESH MINT

473 mL (16 FL OZ)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
LISTERINE   TOTAL CARE PLUS WHITENING
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42002-427
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride0.0221 g  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-427-08236 mL in 1 BOTTLE, PLASTIC
2NDC:42002-427-16473 mL in 1 BOTTLE, PLASTIC
3NDC:42002-427-32946 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/01/2010
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 5/2010
Document Id: 41a87ce6-f495-454e-bee1-d4589efcf8e7
Set id: 52589159-8a11-46e9-8a99-fa75f2a2b64b
Version: 1
Effective Time: 20100511
 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.