LISTERINE  TOTAL CARE PLUS WHITENING- 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 Plus Whitening
FreshMint Flavor

Drug Facts

Active ingredient

Sodium fluoride 0.0221% (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 a day 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%), hydrogen peroxide, , poloxamer 407, flavor, saccharin sodium, sodium lauryl sulfate, eucalyptol, metyl salicylate, thymol, phosphoric acid, disodium phosphate, menthol, sucralose

Questions?

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

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

LISTERINE®
TOTAL CARE
PLUS WHITENING
ANTICAVITY MOUTHWASH

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

6
BENEFITS
IN 1

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

FRESH MINT

946 mL (32 Fl Oz)

IMPORTANT: READ DIRECTIONS
FOR PROPER USE.

Principal Display Panel - 946 mL Bottle Label
LISTERINE   TOTAL CARE PLUS WHITENING
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-427
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:42002-427-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/201005/01/2018
2NDC:42002-427-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/201005/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/01/201005/01/2018
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 4/2016
Document Id: 0efcdbd2-7e58-404b-a88f-4b90e10488c1
Set id: 52589159-8a11-46e9-8a99-fa75f2a2b64b
Version: 4
Effective Time: 20160418
 
Johnson & Johnson Consumer Inc.