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| Product NDC Code | 0699-0701 | ||||
|---|---|---|---|---|---|
| Drug Name | Topex neutral ph fluoride gel mint |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 245593 | ||||
| Labeler Name | Dentsply LLC. Professional Division Trading as "Sultan Healthcare" | ||||
| Packages |
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Overdosage of Topex Neutral pH Fluoride Gel Mint
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Hypersensitivity to fluoride. Do not use if patient has a known allergy to fluoride or any of the other ingredients in this product.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Topex® Fluoride Gels are a family of topical fluoride gel products for professional application in trays.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.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).
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Topex Neutral pH Fluoride Gel Strawberry sodium fluoride FLUORIDE ION FLUORIDE ION CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) WATER SACCHARIN SODIUM METHYLPARABEN BENZOIC ACID SODIUM PHOSPHATE, DIBASIC, ANHYDROUS XANTHAN GUM SODIUM HYDROXIDE Topex Neutral pH Fluoride Gel Mint sodium fluoride FLUORIDE ION FLUORIDE ION CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) WATER D&C YELLOW NO. 10 FD&C BLUE NO. 1 SACCHARIN SODIUM METHYLPARABEN BENZOIC ACID SODIUM PHOSPHATE, DIBASIC, ANHYDROUS XANTHAN GUM SODIUM HYDROXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label NDC 0699-0701-16 REF AD31130 Topex ® NEUTRAL pH NEUTRAL SODIUM FLUORIDE GEL Mint Contains 2.0% Sodium Fluoride (0.9% Fluoride Ion) Rx Only Sultan ® SultanHealthcare CONTENTS: 16 FL OZ. (480mL) PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label
PRINCIPAL DISPLAY PANEL - Clearly Strawberry 16 oz bottle strawberry
Storage and handling
Information about safe storage and handling of the drug product.STORAGE AND HANDLING Store between 68° - 77°F (20° - 25°C). Do not allow to freeze.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API