LISTERINE TOTAL CARE- 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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Fresh Mint Listerine Total Care
Anticavity Mouthwash

Sodium Fluoride and Acidulated Topical Phosphate Solution

Drug Facts

Active ingredient

Sodium fluoride 0.0221% (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 12 years of age and older:
    • use twice daily 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%), flavors, poloxamer 407, sodium lauryl sulfate, phosphoric acid, sucralose, dibasic sodium phosphate, D&C red no. 33, FD&C blue no. 1

Questions?

call 1-888-222-0182, weekdays

PRINCIPAL DISPLAY PANEL - 1.0 Liter Bottle

LISTERINE®
TOTAL CARE

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION
ANTICAVITY MOUTHWASH

  • 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

1.0 LITER (1 qt 1.8 fl oz)

30005904

Principal Display Panel - 1.0 Liter Bottle

LISTERINE  TOTAL CARE
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42002-421
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium fluoride (Fluoride ion) Sodium fluoride2.21 mg  in 10 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-421-711000 mL in 1 BOTTLE, PLASTIC
2NDC:42002-421-72500 mL in 1 BOTTLE, PLASTIC
3NDC:42002-421-73250 mL in 1 BOTTLE, PLASTIC
4NDC:42002-421-9595 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/30/2009
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 11/2009
Document Id: 3c49e5ac-8613-4915-8ff7-70a7a0bc1a7a
Set id: 5e265d8d-134d-4627-9b34-037056d9844f
Version: 1
Effective Time: 20091118
 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.