LISTERINE TOTAL CARE ZERO  FRESHMINT- 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 ZERO, Fresh Mint
Anticavity Mouthwash

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 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 6 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, propylene glycol, flavors, sodium lauryl sulfate, poloxamer 407, sodium benzoate, phosphoric acid, sodium saccharin, disodium phosphate, sucralose, FD&C red no. 40, FD&C blue no.

Questions?

call 1-888-222-0182, weekdays

PRINCIPAL DISPLAY PANEL - 250 mL Bottle Label

LISTERINE®
TOTAL CARE
ZERO™
ANTICAVITY MOUTHWASH

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

6
BENEFITS
IN 1

  • Helps Prevent Cavities
  • Restores Enamel
  • Strengthens Teeth
  • Kills Bad Breath Germs
  • Cleans the Whole Mouth
  • Alcohol Free

FRESH MINT

500 mL (1.05 pt)

IMPORTANT: Read directions
for proper use.

Principal Display Panel
LISTERINE TOTAL CARE ZERO   FRESHMINT
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-443
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride0.221 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
saccharin sodium dihydrate (UNII: SB8ZUX40TY)  
Sucralose (UNII: 96K6UQ3ZD4)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-443-9595 mL in 1 BOTTLE, PLASTIC
2NDC:42002-443-73250 mL in 1 BOTTLE, PLASTIC
3NDC:42002-443-72500 mL in 1 BOTTLE, PLASTIC
4NDC:42002-443-711000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/01/201108/01/2016
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 7/2012
Document Id: 12e5c419-a8d1-40ac-8745-2e15a547f083
Set id: 3ab6f9af-fbb0-43d0-9019-54adc377f1f3
Version: 2
Effective Time: 20120726
 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.