Label: MOUTH RINSE- sodium fluoride mouthwash

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

Drug Label Information

Updated October 13, 2023

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

  • Active Ingredients

    Sodium fluoride 0.0221% (0.01% fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities

  • WARNINGS

    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 under 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 anything 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 20⁰ - 25⁰C (68⁰ - 77⁰ F)

    •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

     Call 1-800-925-4733

  • SPL UNCLASSIFIED SECTION

    Our pharmacists recommend the Walgreens brand.  We invite you to compare to national brands.

    This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, owner of the registered trademark Listerine

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD, DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED

    2021 Walgreen Co.
    MADE IN THE U.S.A. WITH U.S. AND FOREIGN COMPONENTS

  • principal display panel

    Walgreens

    WALGREENS-PHARMACIST RECOMMENDED

    Compare to the active ingrediebt in Listerine Total Care Anticavity Mouthwash

    Anticavity Rinse

    SODIUM FLUORIDE & ACIDULATED

    PHOSPHATE TOPICAL SOLUTION

    Restores Enamel

    Freshens Breath

    • Helps prevent cavities
    • Strengthen teeth
    • Kills bad breath germs

    Eucalyptus Mint flavor

    33.8 fl oz (1 L)

    IMPORTANT: Read directions for proper use

    image description

  • INGREDIENTS AND APPEARANCE
    MOUTH RINSE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0163
    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)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    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:0363-0163-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/15/2006
    Labeler - Walgreen (008965063)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(0363-0163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0363-0163)