Label: ORAL PROJEQT O1 TOOTHPASTETABLETS- sodium fluoride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 22, 2022

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

View All Sections
  • ACTIVE INGREDIENT

    Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

  • INACTIVE INGREDIENT

    D-Sorbitol, Microcrystalline Cellulose, Sodium Chloride, Xylitol, Enzymatically Modified Stevia, Sodium Cocoyl Glutamate, GreenTea Flavor Powder, Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Peppermint Flavor Powder), L-Menthol, Lemon Juice, Aloe Extract Powder, Tea Extract, Hydroxyapatite, Xanthan Gum, Hydroxypropylcellulose, Sodium Bicarbonate, Magnesium Stearate

  • PURPOSE

    Helps protect against cavities and freshen breath.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNING

    Keep out of reach of children Under 6 years of age.
    If more than used for brushing is accidentally swallowed, get
    medical help or contact a Poison Control Center immediately.
    This toothpaste contains 1000ppm of fluorine.
    If children under 6 years of age swallowed an over dose, get
    medical help or contact a Poison Control Center immediately.

  • USES

    for oral use only

  • INDICATION & USAGE SECTION

    Adults and children 6 years of age and older

    Literally chew a tablet then brush teeeth thoroughly,
    preferably after each meal or at least twice a day, every day,
    or as directed by a dentist or physician.
    DO NOT swallow a tablet.
    Children under 6 years of age: Consult a dentist or doctor.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ORAL PROJEQT O1 TOOTHPASTETABLETS 
    sodium fluoride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76058-500
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE5 g
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE1 g
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE0.05 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76058-500-0162 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2022
    Labeler - Sungwon Pharmaceutical Co., Ltd. (689787898)
    Registrant - Sungwon Pharmaceutical Co., Ltd. (689787898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sungwon Pharmaceutical Co., Ltd.689787898manufacture(76058-500)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!