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

  • NDC Code(s): 69968-0787-1, 69968-0787-2, 69968-0787-3, 69968-0787-4, view more
    69968-0787-5
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    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 using without supervision
    • Children under 12 years of age: consult a dentist or doctor
  • Other information

    • store at room temperature
    • cold weather may temporarily cloud this product
  • Inactive Ingredients

    Water, Alcohol (21.6% v/v),Sorbitol, Poloxamer 407,Eucalyptol,Flavor,Methyl Salicylate,Menthol,Phosphoric Acid,Sodium Saccharin

    Thymol,Disodium Phosphate, Sucralose, Red 40, Blue 1

  • 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 - 1000 mL Bottle Label

    ANTICAVITY FLUORIDE MOUTHWASH

    LISTERINE®

    TOTAL CARE

    IMPORTANT: READ DIRECTIONS FOR PROPER USE.

    SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

    6 IN 1

    BENEFITS

    1. 24- HOUR CAVITY PROTECTION+

    2. RESTORES ENAMEL

    3. STRENGTHENS TEETH

    4. FRESHENS BREATH

    5. CLEANS THE WHOLE MOUTH

    6. KILLS BAD BREATH GERMS

    +When used twice daily * bad breath germs

    FRESH MINT

    1.0 L (1 Qt 1.8 fl oz)

    Listerine

  • INGREDIENTS AND APPEARANCE
    LISTERINE TOTAL CARE FRESH MINT ANTICAVITY FLUORIDE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0787
    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)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    THYMOL (UNII: 3J50XA376E)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    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:69968-0787-11000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2023
    2NDC:69968-0787-295 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2023
    3NDC:69968-0787-5500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2023
    4NDC:69968-0787-33 in 1 PACKAGE01/13/2023
    41000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:69968-0787-42 in 1 PACKAGE01/13/2023
    51000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/13/2023
    Labeler - Kenvue Brands LLC (118772437)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!