Label: LISTERINE CLINICAL SOLUTIONS ENAMEL STRENGTH ALPINE MINT- sodium fluoride mouthwash

  • NDC Code(s): 69968-0881-1, 69968-0881-5, 69968-0881-9
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Fluoride 0.02% (0.01% w/v Fluoride Ion)

  • Purpose

    Anticavity

  • Uses

    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 of using without supervision

    Children under 12 years of age: consult a dentist or a doctor

  • Other information

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

    Water, Alcohol (21.6% v/v), Sorbitol, Poloxamer 407, Flavor, Sodium Lauryl Sulfate, Eucalyptol, Sodium Saccharin, Methyl Salicylate, Thymol, Phosphoric Acid, Menthol, Sucralose, Disodium Phosphate, Green 3, Yellow 10

  • 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 - 1 L Bottle Label

    ANTICAVITY FLUORIDE MOUTHWASH

    LISTERINE ®

    CLINICAL

    SOLUTIONS †

    IMPORTANT: READ DIRECTIONS FOR PROPER USE

    SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

    ENAMEL STRENGTH

    Repairs enamel and prevents cavities

    for stronger*, longer lasting teeth

    (*with brushing in a lab study)

    ALPINE MINT

    1L (1 Qt 1.8 Fl Oz)

    Listerine_01

  • INGREDIENTS AND APPEARANCE
    LISTERINE CLINICAL SOLUTIONS ENAMEL STRENGTH ALPINE MINT 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0881
    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
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0881-11000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/26/2024
    2NDC:69968-0881-995 mL in 1 BOTTLE; Type 0: Not a Combination Product02/26/2024
    3NDC:69968-0881-5500 mL in 1 BOTTLE; Type 0: Not a Combination Product02/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/26/2024
    Labeler - Kenvue Brands LLC (118772437)
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