Label: CURODONT REPAIR FLUORIDE PLUS- sodium fluoride sponge

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

Drug Label Information

Updated December 1, 2024

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  • ACTIVE INGREDIENTS

    SODIUM FLUORIDE 0.05%

    (0.02% W/V FLUORIDE ION)

  • PURPOSE

    ANTICAVITY

  • USES

    AIDS IN THE PREVENTION OF DENTAL CAVITIES

    • ANTICAVITY DENTAL RINSE
    • RESTORES ENAMEL
    • FOR THE TREATMENT OF WHITE SPOTS
  • WARNINGS

    FOR TOPICAL INTRAORAL USE ONLY. FOR PROFESSIONAL OFFICE USE ONLY. THIS PRODUCT IS NOT INTENDED FOR HOME OR UNSUPERVISED CONSUMER USE.

  • 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

    Usual dosage is one treatment per tooth. After prophylaxis treatment, remove the pellicle of the concerned tooth by using 2% sodium hypochlorite for 10 seconds. Rinse the tooth surface with water. Remove inorganic deposits by pushing together the two cylinders and apply product with sponge on treatment area.

    After treatment time of five minutes have patient expectorate residues. For maximum benefits for the prevention of caries, instruct patient not to rinse, eat or drink for 30 minutes.

  • OTHER INFORMATION

    DO NOT USE IF SAFETY PACHAGING IS BROKEN OR MISSING.

    SINGLE USE ONLY.

    STORE IN A DRY AND COOL PLACE.

  • INACTIVE INGREDIENTS

    WATER, CHLORHEXIDINE DIGLUCONATE, TROMETHAMINE, TREHALOSE DIHYDRATE, OLIGOPEPTIDE-104, HYDROXYPROPYL METHYLCELLULOSE, CITRIC ACID, SODIUM HYDROXIDE.

  • PRINCIPAL DISPLAY PANEL

    UC

  • INGREDIENTS AND APPEARANCE
    CURODONT REPAIR FLUORIDE PLUS 
    sodium fluoride sponge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72247-109
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    TREHALOSE DIHYDRATE (UNII: 7YIN7J07X4)  
    OLIGOPEPTIDE 104 (UNII: MUM5TLH7X6)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72247-109-1210 in 1 BOX08/27/2023
    10.1 mL in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02108/27/2023
    Labeler - CREDENTIS AG (485450345)
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