Listerine Total Care Zero Fresh Mint

Dosage form: mouthwash
Ingredients: Sodium Fluoride 0.1mg in 1mL
Labeler: Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.
NDC Code: 42002-507

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.

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, flavor, sodium lauryl sulfate, poloxamer 407, sodium benzoate, phosphoric acid, eucalyptol, thymol, methyl salicylate, sodium saccharin, menthol, disodium phosphate, sucralose, FD&C red no. 40, FD&C blue no. 1

Questions?

Call toll-free 1-888-222-0182 or 215-273-8755 (collect)

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

LISTERINE®
TOTAL CARE
ZERO™
ANTICAVITY MOUTHWASH

6
BENEFITS
IN 1

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

FRESH MINT

500 mL (1.05 Pt)

IMPORTANT:
READ DIRECTIONS
FOR PROPER USE.

LISTERINE TOTAL CARE ZERO   FRESH MINT
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-507
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Sorbitol 
Propylene Glycol 
Sodium Lauryl Sulfate 
Poloxamer 407 
Sodium Benzoate 
Phosphoric Acid 
Eucalyptol 
Thymol 
Methyl Salicylate 
Saccharin Sodium 
Menthol 
Sodium Phosphate, Dibasic, Anhydrous 
Sucralose 
FD&C Red No. 40 
FD&C Blue No. 1 
Packaging
#Item CodePackage Description
1NDC:42002-507-9627 mL in 1 BOTTLE, PLASTIC
2NDC:42002-507-9595 mL in 1 BOTTLE, PLASTIC
3NDC:42002-507-73250 mL in 1 BOTTLE, PLASTIC
4NDC:42002-507-72500 mL in 1 BOTTLE, PLASTIC
5NDC:42002-507-711000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/25/2012
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 09/2014
 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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