Label: TOPEX NEUTRAL PH FLUORIDE GEL STRAWBERRY- sodium fluoride gel
TOPEX NEUTRAL PH FLUORIDE GEL MINT- sodium fluoride gel

  • NDC Code(s): 0699-0701-16, 0699-0702-16
  • Packager: Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
  • Category: HUMAN PRESCRIPTION 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 November 27, 2017

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

  • INDICATIONS AND USAGE

    Topex® Fluoride Gels are indicated for topical application to teeth to aid in the prevention of dental caries.

    The non-acidic nature of Neutral pH (NaF) is recommended for patients with ceramic or composite restorations.

    Treatment frequency should not exceed 4 treatments per year.

  • 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. Fill applicator tray no more than 1/3 full with Fluoride gel.

    4. Dry tooth surface and insert tray in mouth.

    5. Use suction throughout treatment.

    6. Have patient bite down for a minimum of 60 seconds to a maximum of 4 minutes. (A slight biting or chewing motion will provide interproximal coverage)

    7. Remove tray and have patient expectorate excess gel. Do not swallow.

    8. Instruct patient not to eat, drink, or rinse for 30 minutes after treatment.

  • DOSAGE FORMS AND STRENGTHS

    APF topical gel contains 2.59% sodium fluoride (1.23% fluoride ion).

    NaF topical gel contains 2.0% sodium fluoride (0.9% fluoride ion).

  • CONTRAINDICATIONS

    Hypersensitivity to fluoride. Do not use if patient has a known allergy to fluoride or any of the other ingredients in this product.

  • WARNINGS AND PRECAUTIONS

    Do not swallow. Harmful if swallowed.
    Keep out of reach of children.
    May contain FD&C Yellow #5 & FD&C Yellow #6
    This product is not intended for home or unsupervised consumer use.
    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.

  • 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, urticarial, gastric distress, headache, and weakness.

  • 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.

  • DESCRIPTION

    Topex® Fluoride Gels are a family of topical fluoride gel products for professional application in trays.

  • STORAGE AND HANDLING

    Store between 68° - 77°F (20° - 25°C). Do not allow to freeze.

  • PRINCIPAL DISPLAY PANEL - Mint 16 oz bottle

    Mint

  • PRINCIPAL DISPLAY PANEL - Clearly Strawberry 16 oz bottle

    strawberry

  • INGREDIENTS AND APPEARANCE
    TOPEX NEUTRAL PH FLUORIDE GEL  STRAWBERRY
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-0702
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION9 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-0702-16495 g in 1 BOTTLE; 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
    TOPEX NEUTRAL PH FLUORIDE GEL  MINT
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-0701
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION9 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    WATER (UNII: 059QF0KO0R)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-0701-16495 g in 1 BOTTLE; 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 "Sultan Healthcare" (167087753)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dentsply Caulk083235549manufacture(0699-0701, 0699-0702)