LISTERINE TOTAL CARE ZERO ANTICAVITY FRESH MINT- sodium fluoride mouthwash 
Johnson & Johnson Consumer 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, 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

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
  • Freshens Breath

FRESH MINT

500 mL (1.05 Pt)

IMPORTANT: Read directions
for proper use.

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
LISTERINE TOTAL CARE ZERO ANTICAVITY  FRESH MINT
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-507
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.1 mg  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)  
Eucalyptol (UNII: RV6J6604TK)  
Thymol (UNII: 3J50XA376E)  
Methyl Salicylate (UNII: LAV5U5022Y)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Menthol, Unspecified Form (UNII: L7T10EIP3A)  
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
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:42002-507-9627 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/25/201210/01/2018
2NDC:42002-507-9595 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/25/201210/01/2018
3NDC:42002-507-73250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/25/201210/01/2018
4NDC:42002-507-72500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/25/201210/01/2018
5NDC:42002-507-711000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/25/201210/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/25/201210/01/2018
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2016
 
Johnson & Johnson Consumer Inc.