Label: LISTERINE NATURALS ANTICAVITY - HERBAL MINT- sodium fluoride mouthwash

  • NDC Code(s): 69968-0322-1
  • 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 room temperature
    • cold weather may temporarily cloud this product
  • Inactive ingredients

    water, sorbitol solution, alcohol (21.6%), poloxamer 407, flavor, eucalyptol, methyl salicylate, thymol, stevia rebaudiana leaf/stem extract, phosphoric acid, menthol, disodium phosphate

  • 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 - 1.0 L Bottle Label

    LISTERINE®
    naturals™
    FORMULA WITH FLUORIDE

    ANTICAVITY MOUTHWASH

    SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION
    Natural Fluoride Formula for
    Stronger Teeth, Restores
    Essential Minerals to Enamel
    & Kills Bad Breath Germs

    *vs. LISTERINE® Fluoride rinsesHERBAL MINT

    1.0L (1 Qt 1.8 Fl OZ)

    IMPORTANT: READ
    DIRECTIONS FOR PROPER USE.

    PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE NATURALS ANTICAVITY - HERBAL MINT 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0322
    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)  
    Eucalyptol (UNII: RV6J6604TK)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Thymol (UNII: 3J50XA376E)  
    Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)  
    Phosphoric Acid (UNII: E4GA8884NN)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0322-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/20/201301/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35512/20/201301/05/2021
    Labeler - Johnson & Johnson Consumer Inc. (002347102)