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

  • NDC Code(s): 69968-0194-1, 69968-0194-2, 69968-0194-5, 69968-0194-9
  • 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 4, 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 6 years of age and older:
      • use twice daily after brushing your teeth with a toothpaste
      • vigorously swish 10mL (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
      • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
      • supervise children as necessary until capable of using without supervision
    • Children under 6 years of age: consult a dentist or doctor
  • Other information

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

    Water, Sorbitol, Propylene Glycol, Poloxamer 407, Sodium Lauryl Sulfate, Flavor, Sodium Benzoate, Phosphoric Acid, Eucalyptol, Methyl Salicylate, Thymol, Sodium Saccharin, Menthol, 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 PHOSPAHTE TOPICAL SOLUTION

    ZERO ALCOHOL

    6 IN 1

    BENEFITS

    1. 24-HOUR CAVITY PROTECTION+
    2. RESTORES ENAMEL
    3. STRENGTHENS TEETH
    4. FRESHENS BREATH
    5. CLEANS WHOLE MOUTH
    6. KILLS BAD BREATH GERMS

    +when used twice daily *bad breath germs

    1.0L (1 Qt 1.8 Fl Oz)

    FRESH MINT

    Listerine

  • INGREDIENTS AND APPEARANCE
    LISTERINE TOTAL CARE ZERO ALCOHOL ANTICAVITY   FRESH MINT
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0194
    Route of AdministrationORAL
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0194-227 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/25/2012
    2NDC:69968-0194-995 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/25/2012
    3NDC:69968-0194-5500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/25/2012
    4NDC:69968-0194-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/25/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/25/2012
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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