Label: NUPRO FLUORIDES NAF ORAL SOLUTION MINT- sodium fluoride gel
NUPRO FLUORIDES NAF ORAL SOLUTION APPLE CINNAMON- sodium fluoride gel
NUPRO FLUORIDES NAF ORAL SOLUTION MANDARIN ORANGE- sodium fluoride gel

  • NDC Code(s): 65222-401-32, 65222-411-32, 65222-421-32
  • Packager: Dentsply LLC. Professional Division Trading as "DENTSPLY Professional"
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 18, 2022

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  • INDICATIONS AND USAGE

    For topical application to aid in the protection against dental caries. The non-acidic fluoride is safe for patients with porcelain, composite restorations, and sealants.

  • DOSAGE AND ADMINISTRATION

    1. Remove cap from bottle, remove induction seal. DO NOT USE IF SEAL IS BROKEN.
    2. Replace cap and shake well.
    3. Dispense a narrow ribbon of gel into applicator trays.
    4. Air dry teeth thoroughly and insert trays in mouth with head tilted slightly forward.
    5. Instruct patient to continue light biting action for 1 minute (or up to 4 minutes).
    A slight chewing motion enhances interproximal coverage.
    6. Use suction throughout treatment.
    7. Have patient expectorate after treatment.
    8. Instruct patient not to eat, drink, or rinse for 30 minutes.


    Recommended Frequency: Not to exceed four 4 treatments per year

  • CONTRAINDICATIONS

    Hypersensitivity to fluoride

  • WARNINGS AND PRECAUTIONS

    Do not swallow. Keep out of reach of children.
    May contain FD&C Yellow No. 6.
    Safety and effectiveness below age 3 have not been established. There have been no long-term animal studies with this product to evaluate carcinogenic, mutagenic, or impairment of fertility potential.

  • OVERDOSAGE

    If treatment dose is swallowed [less than 100 mg F], administer milk, limewater, or calcium-type antacid. In case of larger doses [1 pint contains 4.5 grams F ion, which is a lethal dose], use ipecac syrup emetic and immediately seek medical help.

  • ADVERSE REACTIONS

    Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

  • HOW SUPPLIED

    2.0% sodium fluoride (0.9% fluoride ion) gel supplied in 12 fl. oz. bottles.

  • STORAGE

    Store at room temperature. Protect from freezing.

  • SDS WARNINGS

    SAFETY DATA SHEET is available on our website, www.dentsplysirona.com, or by contacting Customer Service at 1-800-989-8826.

    warning icons

  • MANUFACTURED FOR

    Manufactured For:
    DENTSPLY Professional
    1301 Smile Way
    York, PA 17404 USA
    1-800-989-8826

    Made in USA.

  • PRINCIPAL DISPLAY PANEL - Mandarin Orange

    mandarin orange

  • PRINCIPAL DISPLAY PANEL - Mint

    mint bottle

  • PRINCIPAL DISPLAY PANEL - Apple Cinnamon

    apple cinnamon

  • INGREDIENTS AND APPEARANCE
    NUPRO FLUORIDES NAF ORAL SOLUTION   MINT
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-401
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65222-401-327 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/1974
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/01/1974
    NUPRO FLUORIDES NAF ORAL SOLUTION   APPLE CINNAMON
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-421
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorAPPLE (Apple Cinnamon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65222-421-327 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/197404/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/01/197404/07/2023
    NUPRO FLUORIDES NAF ORAL SOLUTION   MANDARIN ORANGE
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-411
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorORANGE (Mandarin Orange) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65222-411-327 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/1974
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/01/1974
    Labeler - Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" (144140845)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dentsply Caulk083235549MANUFACTURE(65222-401, 65222-411, 65222-421)
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