NUPRO FLUORIDES WILD CHERRY (SODIUM FLUORIDE) GEL NUPRO FLUORIDES BUBBLE GUM (SODIUM FLUORIDE) GEL [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "DENTSPLY PROFESSIONAL"]

NUPRO FLUORIDES WILD CHERRY (SODIUM FLUORIDE) GEL NUPRO FLUORIDES BUBBLE GUM (SODIUM FLUORIDE) GEL [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "DENTSPLY PROFESSIONAL"]
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NDC 65222-431-44, 65222-451-44
Set ID 6154542f-4ea4-7155-e053-2991aa0ad998
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Dentsply LLC. Professional Division Trading as "DENTSPLY Professional"
Generic Name
Product Class
Product Number
Application Number
  • INDICATIONS AND USAGE

    For topical application to aid in the protection against dental caries.

  • 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.
    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. Laboratory studies have indicated that repeated use of APF may dull porcelain, composite restorations and sealants.

  • 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

    2.59% sodium fluoride (1.23% 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.

    SDS warning

  • MANUFACTURED FOR

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

    Made in the U.S.A

  • PRINCIPAL DISPLAY PANEL - Wild Cherry

    wild cherry

  • PRICIPAL DISPLAY PANEL - Bubble Gum

    bubble gum

  • INGREDIENTS AND APPEARANCE
    NUPRO FLUORIDES  WILD CHERRY
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-431
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION25.9 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROFLUORIC ACID (UNII: RGL5YE86CZ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRY (Wild Cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65222-431-447 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/1900
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/1900
    NUPRO FLUORIDES  BUBBLE GUM
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-451
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION25.9 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROFLUORIC ACID (UNII: RGL5YE86CZ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65222-451-447 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/1900
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/1900
    Labeler - Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" (144140845)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dentsply Caulk083235549manufacture(65222-431, 65222-451)

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