Label: CURODONT PROTECT- stannous fluoride paste, dentifrice

  • NDC Code(s): 72247-107-10, 72247-107-13
  • Packager: CREDENTIS AG
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    STANNOUS FLUORIDE 0.454%

    (0.14% W/V FLUORIDE ION)

  • PURPOSE

    ANTICAVITY AND ANTISENSITIVITY

  • USE

    • AIDS IN THE PREVENTION OF DENTAL CAVITIES AND BUILDS INCREASING PROTECTION AGAINST PAINFUL SENSITIVITY OF THE TEETH.
  • WARNINGS

    Stop use and ask a doctor if

    • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
    • pain/sensitivity still persists after 4 weeks of 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

    • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
    • Children under 2 years of age: Consult a dentist or doctor.
  • OTHER INFORMATION

    This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

  • INACTIVE INGREDIENTS

    Sorbitol, Water, Hydrated Silica, Sodium Tripolyphosphate, Sodium Gluconate, Xylitol, Cellulose Gum, Oligopeptide-104, Sodium Hydroxide, Phosphoric Acid.

  • PRINCIPAL DISPLAY PANEL

    PDP

    DF

  • INGREDIENTS AND APPEARANCE
    CURODONT PROTECT 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72247-107
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.14 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    OLIGOPEPTIDE 104 (UNII: MUM5TLH7X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72247-107-131 in 1 BOX08/27/2023
    10.13 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:72247-107-1010 in 1 BOX08/27/2023
    20.13 g in 1 TUBE; 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)