Label: ANTICAVITY- 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 ingredient

    Sodium fluoride 0.0221% (0.01% w/v 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 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 then spit out
    • do not swallow the rinse
    • do not eat or drink for 30 minutes after rinsing
    • instruct children uder 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 controlled room temperature 20°-25° C to (68° - 77°F)
    • cold weather may temporarily cloud this product
  • inactive ingredients

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

  • Adverse reaction section

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

    DISTRIBUTED BY:
    RITE AID, 30 HUNTER LANE
    CAMP HILL, PA 17011
    IF YOU ARE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.

  • principal display panel

    RITE AID PHARMACY

    Sealed With Printed Neckband For Your Protection

    IMPORTANT: READ DIRECTIONS FOR PROPER USE

    Compare to the active ingredent in Listerine Total Care Anticavity Mouthwash

    Anticavity mouthwash

    Sodium Fluoride and Acidulated Phosphate Topical Solution

    Multiple Benefits In One

    helps preventcavities

    restores enamel

    helps strengthen teeth

    helps kill bad breath

    leaves the mouth feeling clean

    Mint

    1 Liter (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-5927
    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)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHOSPHORAMIDIC ACID (UNII: 9Q189608GB)  
    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:11822-5927-81000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/13/2009
    Labeler - Rite Aid (014578892)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(11822-5927)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11822-5927)