Label: CLOSYS FLUORIDE RINSE- sodium fluoride rinse

  • NDC Code(s): 58578-1234-1, 58578-1234-2
  • Packager: Rowpar Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

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

  • PURPOSE

    Anticavity

  • USE:

    Aids in the prevention of dental cavities

  • WARNING:

  • KEEP OUT OF REACH OF CHILDREN

    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 once a day after brushing your teeth with a toothpaste · remove cap · pour out and vigorously swish 10 ml (2 tsp) 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) · supervise children as necessary until capable of using without supervision ·
    Children under 6 years of age: consult a dentist or doctor.

  • OTHER INFORMATION:

    Do not use if safety seal is broken or missing

  • INACTIVE INGREDIENTS:

    water, stabilized chlorine dioxide, trisodium phosphate, citric acid, peppermint flavor, sucralose

  • QUESTIONS

    Questions or comments? Call 1-800-643-3337

  • SPL UNCLASSIFIED SECTION

  • Packaging

    473ml Inner Label

    473 mL Bottle Label

    473 mL Carton

    Carton Label

    100 ml Label

    100 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CLOSYS  FLUORIDE RINSE
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58578-1234
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CHLORINE DIOXIDE (UNII: 8061YMS4RM)  
    SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58578-1234-11 in 1 BOX02/18/2016
    1473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58578-1234-2100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/18/2016
    Labeler - Rowpar Pharmaceuticals, Inc. (783704661)
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