Label: LISTERINE TOTAL CARE STAIN REMOVER ANTICAVITY FLUORIDE FRESH MINT- sodium fluoride mouthwash

  • NDC Code(s): 69968-0537-1, 69968-0537-3
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 6, 2023

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  • SPL UNCLASSIFIED SECTION

    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, Sorbitol, Alcohol (21.6% v/v), Hydrogen Peroxide, Poloxamer 407, Flavor, 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)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

    ANTICAVITY FLUORIDE MOUTHWASH

    LISTERINE ®

    TOTAL CARE
    STAIN REMOVER
    IMPORTANT: READ DIRECTIONS FOR PROPER USE
    SODIUM FLUORIDE &
    ACIDULATED PHOSPHATE TOPICAL SOLUTION

    6 IN 1
    BENEFITS
    1.HELPS PREVENT CAVITIES
    2.RESTORES ENAMEL
    3.STRENGTHENS TEETH
    4.KILLS BAD BREATH GERMS
    5.CLEANS THE WHOLE MOUTH
    6.FRESHENS BREATH

    FRESH MINT

    946 mL (32 Fl Oz)

    PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE TOTAL CARE STAIN REMOVER ANTICAVITY FLUORIDE FRESH MINT 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0537
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0537-1473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2010
    2NDC:69968-0537-3946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201009/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2010
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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