Label: ANTICAVITY- sodium fluoride rinse

  • 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 December 14, 2022

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

  • Active Ingredients

    Sodium fluoride 0.02% (0.01% w/v fluoride ion)

  • Purpose

    Anticavity rinse

  • Use

    aids in the prevention of dental cavities

  • Warning

    for this product

  • 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 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
    • 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, flavor, sodium lauryl sulfate, poloxamer 407, sodium benzoate, phosphoric acid, sodium saccharin, disodium phosphate, sucralose, red 40, blue 1

  • Disclaimer

    This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Zero Anticavity Mouthwash.

    This product is not intended to replace brushing or flossing.

    SEALED WITH PRINTD NECKBND FOR YOUR PROTCTION

    PUBLIX GUARNTEE: COMPLETE SATIFACTION OR YOUR MONEY BACK

  • Adverse reactions section

    DISTRIBUTED BY PUBLIX SUPER MARKETS, INC

    3300 PUBLIX CORPORATE PARKWAY

    LAKELAND, FL 33811 publix.com

  • principal display panel

    P

    ANTICAVITY

    alcoholfree

    MOUTHWASH

    Sodium Fluoride & Acidulated

    Phosphate Topical Solution

    Fress mint flavor

    • Alcohol free
    • Restores enamel
    • Helps strengthen teeth to fight cavities
    • Helps kill germs that cause bad breath

    Compare to Listerine Total Care Zero Anticavity Mouthwash

    Cleans the entire mouth

    IMPORTANT: Read directions for proper use.

    33.8 FL OZ (1.05 QT) 1 L

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-971
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 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)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    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:56062-971-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/08/2019
    Labeler - publix (006922009)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(56062-971)