Label: ANTICAVITY- sodium fluoride mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2024

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

  • Active Ingredient

    Sodium Fluoride 0.02% W/V (0.01% fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities

  • Warnings 

    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 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 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 9 (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 controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)
    • cold weather may temporarily cloud this product

  • Inactive ingredients

    water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

  • Questions or Comments?

    1-800-632-6900

  • Disclaimer

    *Listerine ® is a registered trademark of Kenvue, Inc.

    **When used 2X daily

  • Adverse Reactions

    PROUDLY DISTRIBUTED BY THE KROGER CO. CINCINNATI, OH 45202

    MADE IN USA WITH DOMESTIC AND FOREIGN COMPONENTS

    *THIS PRODUCT IS NOT INTENDED TO REPLACE BRUSHING OR FLOSSING

    Quality Guaranteed

    Kroger.com/guarantee

    800-632-6900

    DSP-TN-21091

    DSP-MO-20087

  • principal display panel

    COMPARE TO THE ACTIVE INGREDIENTS OF LISTERINE ® TOTAL CARE FRESH MINT

    *SEE BACK LABEL

    Kroger ®

    6 IN 1 CARE

    ANICAVITY MOUTHWASH

    LONG-LASTING CAVITY PROTECTION - FLUORIDE

    EUCALYPTUS MINT

    1. 24HR CAVITY PROTECTION**
    2. RESTORES ENAMEL
    3. STRENGTHENS TEETH
    4. FRESHENS BREATH
    5. CLEANS WHOLE MOUTH†
    6. KILLS BAD BREATH GERMS

    KILLS 99.9% OF GERMS†

    †THAT CAUSE BAD BREATH

    QUALITY GUARANTEED 

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION. 

    IMPORTANT: READ DIRECTIONS FOR PROPER USE.

    16.9 FL OZ (1.05 PT) 500mL

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-163
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    THYMOL (UNII: 3J50XA376E)  
    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:30142-163-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/12/2005
    2NDC:30142-163-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02109/12/2005
    Labeler - Kroger (006999528)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(30142-163)