Label: ANTICAVITY- sodium fluoride rinse

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

Drug Label Information

Updated October 20, 2023

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  • Active Ingredient

    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 immediately

  • 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 miute 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 20⁰ - 25⁰ C (68⁰ - 77⁰ F)
    • 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

  • Questions?

    1-888-593-0593

  • SPL UNCLASSIFIED SECTION

    Sealed With Printed Neckband For Your Protection

    This product is not intended to replace brushing or flossing

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

    Manufactured for Big Lots By Vi-Jon, Inc.

    8515 Page Avenue

    St. Louis, MO 63114

  • principal display panel

    SOUNDBODY

    Compare to the active ingredient in Listerine Total Care Zero Anticavity Mouthwash*

    BURN FREE

    Fluoride Anti-Cavity Mouthrinse

    Sodium Fluoride and Acidulated Phosphate Topical Solution

    Helps Strengthen Teeth to Fight Cavities

    Helps Restore Enamel

    Kill Bad Breath Germs

    Freshens Breath

    Cleans the Entire Mouth

    Alcohol Free

    IMPORTANT: read directions for proper use.

    EUCALYPTUS MINT

    1 L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50594-971
    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:50594-971-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02109/19/2017
    Labeler - Big Lots (017885351)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(50594-971)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(50594-971)
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