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: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 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

    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 - Johnson & Johnson Consumer Inc. (118772437)
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