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
  • 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 August 31, 2023

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  • 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 finalpart35508/27/2023
    Labeler - CREDENTIS AG (485450345)
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