LISTERINE TOTAL CARE  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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Fresh Mint Listerine Total Care
Anticavity Mouthwash
Sodium Fluoride and Acidulated Topical Phosphate Solution

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

Questions?

call 1-888-222-0182, or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label

LISTERINE®
TOTAL CARE
FRESH MINT

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

1.0 L (1 Qt. 1.8 Fl Oz)

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

Principal Display Panel - 1.0 L Bottle Label
LISTERINE TOTAL CARE   ANTICAVITY - FRESH MINT
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-421
Route of AdministrationDENTAL
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)  
Alcohol (UNII: 3K9958V90M)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Eucalyptol (UNII: RV6J6604TK)  
Methyl Salicylate (UNII: LAV5U5022Y)  
Thymol (UNII: 3J50XA376E)  
Phosphoric Acid (UNII: E4GA8884NN)  
Sucralose (UNII: 96K6UQ3ZD4)  
Menthol, Unspecified Form (UNII: L7T10EIP3A)  
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
FD&C red no. 40 (UNII: WZB9127XOA)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-421-711000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/30/200912/01/2019
2NDC:42002-421-72500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/30/200912/01/2019
3NDC:42002-421-73250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/30/200912/01/2019
4NDC:42002-421-9595 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/30/200912/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/30/200912/01/2019
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 4/2018
 
Johnson & Johnson Consumer Inc.