LISTERINE TOTAL CARE STAIN REMOVER ANTI CAVITY  FRESHMINT- 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 STAIN REMOVER ANTI CAVITY MOUTH WASH FRESH MINT

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

Stop use and ask a dentist if oral irritation or tooth sensitivity occurs.

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

  • protect from excessive heat (40°C/104°F)

Inactive ingredients

water, alcohol (21.6%), sorbitol, hydrogen peroxide, poloxamer 407, sodium saccharin, sodium lauryl sulfate, eucalyptol, methyl salicylate, thymol,phosphoric acid, menthol, disodium phosphate, sucralose

Questions?

call toll-free 888-222-0182 or 215-273-8755 (Collect)

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

LISTERINE®
TOTAL CARE
STAIN REMOVER
ANTICAVITY MOUTHWASH
SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

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

FRESH MINT
6
BENEFITS
IN 1 ®

946 mL (32 Fl OZ)
IMPORTANT: READ DIRECTIONS
FOR PROPER USE.

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
LISTERINE TOTAL CARE STAIN REMOVER ANTI CAVITY   FRESHMINT
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-621
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)  
Hydrogen Peroxide (UNII: BBX060AN9V)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Eucalyptol (UNII: RV6J6604TK)  
Methyl Salicylate (UNII: LAV5U5022Y)  
Thymol (UNII: 3J50XA376E)  
Phosphoric Acid (UNII: E4GA8884NN)  
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
Menthol, Unspecified Form (UNII: L7T10EIP3A)  
Sucralose (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-621-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/201008/18/2021
2NDC:42002-621-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/201004/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/01/201008/18/2021
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2020
Document Id: 768545f0-dcc2-4934-bbb8-f4687e4c4442
Set id: 11fcdf64-ae77-417d-9318-f343ac3c04f3
Version: 2
Effective Time: 20200911
 
Johnson & Johnson Consumer Inc.