Label: LISTERINE FLUORIDE DEFENSE ANTICAVITY MINT SHIELD- sodium fluoride mouthwash

  • NDC Code(s): 42002-450-71
  • 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 April 30, 2020

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

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

    • store at controlled room temperature 20° - 25°C (68° - 77°F)
    • cold weather may temporarily cloud this product
  • Inactive ingredients

    water, sorbitol solution, alcohol (21.6%), poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphoric acid, sucralose, menthol, disodium phosphate, FD&C blue no. 1

  • Questions?

    Call toll-free 1-888-222-0182 or 215-273-8755 (collect)

  • SPL UNCLASSIFIED SECTION

    Dist: Johnson & Johnson Healthcare Products
    Division of McNEIL-PPC, Inc.
    Skillman, NJ 08558-9418 USA

  • PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label

    LISTERINE®
    FLUORIDE
    DEFENSE™
    ANTICAVITY MOUTHWASH

    SODIUM FLUORIDE & ACIDULATD PHOSPHATE TOPICAL SOLUTION
    Shields Teeth from
    Cavity Causing Acids,
    Rebuilds Minerals &
    Strengthens Enamel

    IMPORTANT: Read directions
    for proper use.
    Replaces LISTERINE® Restoring

    FROM THE #1 DENTIST RECOMMENDED BRAND*
    #1

    MINT SHIELD®

    Principal Display Panel - 1.0 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE FLUORIDE DEFENSE ANTICAVITY MINT SHIELD 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-450
    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)  
    Alcohol (UNII: 3K9958V90M)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Eucalyptol (UNII: RV6J6604TK)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Thymol (UNII: 3J50XA376E)  
    Phosphoric Acid (UNII: E4GA8884NN)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42002-450-711000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/201107/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/01/201107/15/2021
    Labeler - Johnson & Johnson Consumer Inc. (002347102)