Label: CURODONT REPAIR FLUORIDE PLUS- sodium fluoride sponge

  • 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 11, 2022

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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
  • WARNING

    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.

  • 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. For patients with rampant or active caries, repeat treatment once or twice every six months.

  • 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

  • PRINCIPAL DISPLAY PANEL

    vVardis Professional Switzerland

    Curodont (tm) Repair Fluoride Plus

    vVardis technology

    Anticavity dental treatment rinse

    Contains 10 single packed single use applicator with 0.1ml rinse each

    10 x 0.1 ml (10 x 0.033 FL OZ)

    Important: read directions for proper use - see inside

    curodont repair fluoride p1

    curodont repair fluoride p2

    curodont repair fluoride 1unit

  • INGREDIENTS AND APPEARANCE
    CURODONT REPAIR FLUORIDE PLUS 
    sodium fluoride sponge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72247-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    TREHALOSE DIHYDRATE (UNII: 7YIN7J07X4)  
    OLIGOPEPTIDE-10 (UNII: Q46328TRNK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72247-101-1210 in 1 BOX01/11/2019
    1NDC:72247-101-110.1 mL in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/11/2019
    Labeler - CREDENTIS AG (485450345)
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