Label: ANTICAVITY FLUORIDE RINSE- 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 January 12, 2023

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  • Active ingredient

    Sodium fluoride 0.05% (0.02% w/v fluoride ion)

    Purpose

    Anticavity rinse

  • 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, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
    • remove cap
    • pour 10 milliters (10 mL mark on inside of cap): do not fill above the 10 mL mark 
    • vigorously swish 10 milliliters 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)
    • 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
  • Inactive ingredients

    benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride rinse.

    Distributed by: TOPCO ASSOCIATES LLC

    7711 GROSS POINT ROAD, SKOKIE, IL 60077

    QUESTIONS? 1-888-423-0139

  • principal display panel

    TOP CARE

    Children's

    Alcohol Free

    Anticavity

    Fluoride

    Rinse

    • Strong cavity protection
    • Helps strengthen teeth
    • Helps prevent cavities
    • Freshens breath

    Bubble Gum Flavor

    COMPARE TO ACT

    active ingredient

    IMPORTANT: READ DIRECTIONS FOR PROPER USE

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    18 FL OZ (532 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY FLUORIDE RINSE 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUM (Bubble Gum Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-004-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/08/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/08/2004
    Labeler - Topco Associates LLC (006935977)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(36800-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(36800-004)
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