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| Product NDC Code | 0699-0150 | ||||
|---|---|---|---|---|---|
| Drug Name | Topex 60 second fluoride foam strawberry |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | AEROSOL, FOAM | ||||
| RxCUI drug identifier | 1652849 | ||||
| Labeler Name | Dentsply LLC. Professional Division Trading as "Sultan Healthcare" | ||||
| Packages |
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Overdosage of Topex 60 Second Fluoride Foam Strawberry
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 ion), administer milk, limewater, or calcium-type antacid. In case of larger doses, use ipecac syrup emetic and immediately seek medical help.Overdose symptoms include nausea, vomiting, diarrhea, and abdominal pain.
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 Foams are a family of topical fluoride foam products for professional application in trays. The family consists of APF Foam (1.23% fluoride ion at a pH between 3.0-4.5) and Neutral pH Foam (0.9% fluoride ion at a pH between 6.5 -7.5). Topex® Foam Fluoride products do not contain chlorofluorocarbon propellants.
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 can. If this is the first time using can, break the protective shipping tab by gently lifting up the trigger. 2. Shake can thoroughly for at least 10 seconds before each use. 3. Completely invert can and slowly depress trigger to dispense foam into a fluoride tray 4. Air dry teeth thoroughly and insert tray into patient’s mouth. Have patient close into the tray and use a slight chewing motion to ensure interproximal coverage. 5. Leave tray in contact with teeth between 1-4 minutes. Use a saliva ejector during treatment to minimize ingestion of product 6. Remove tray after elapsed time and have patient expectorate. Instruct patient to refrain from drinking, eating, or rinsing for 30 minutes after treatment. Treatment frequency should not exceed 4 treatments per year.
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 Foam contains 2.73% 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 Foams 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.
Spl product data elements
Usually a list of ingredients in a drug product.Topex 60 Second Fluoride Foam Bubble Fun sodium fluoride SODIUM FLUORIDE FLUORIDE ION CETYL PHOSPHATE STEARIC ACID SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 CETYL ALCOHOL OLETH-3 PHOSPHATE WATER SODIUM BENZOATE SODIUM METHYL COCOYL TAURATE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE BENZALDEHYDE APAFLURANE Bubble Fun Topex 60 Second Fluoride Foam Grape sodium fluoride SODIUM FLUORIDE FLUORIDE ION SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 CETYL ALCOHOL OLETH-3 PHOSPHATE WATER SODIUM BENZOATE SODIUM METHYL COCOYL TAURATE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE BENZALDEHYDE APAFLURANE CETYL PHOSPHATE STEARIC ACID Topex 60 Second Fluoride Foam Spearmint sodium fluoride SODIUM FLUORIDE FLUORIDE ION APAFLURANE CETYL PHOSPHATE SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 CETYL ALCOHOL OLETH-3 PHOSPHATE WATER SODIUM BENZOATE SODIUM METHYL COCOYL TAURATE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE BENZALDEHYDE STEARIC ACID Spearmint Topex 60 Second Fluoride Foam Orange Cream sodium fluoride SODIUM FLUORIDE FLUORIDE ION CETYL PHOSPHATE STEARIC ACID SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 CETYL ALCOHOL OLETH-3 PHOSPHATE WATER SODIUM BENZOATE SODIUM METHYL COCOYL TAURATE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE BENZALDEHYDE APAFLURANE Orange Cream Topex 60 Second Fluoride Foam Strawberry sodium fluoride SODIUM FLUORIDE FLUORIDE ION SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 CETYL ALCOHOL OLETH-3 PHOSPHATE WATER SODIUM BENZOATE STEARIC ACID SODIUM METHYL COCOYL TAURATE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE CETYL PHOSPHATE BENZALDEHYDE APAFLURANE
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 - Strawberry 4.4 oz strawberry
PRINCIPAL DISPLAY PANEL - Spearmint 4.4 oz spearmint
PRINCIPAL DISPLAY PANEL - Bubble Fun 4.4 oz bubble fun
PRINCIPAL DISPLAY PANEL - Grape 4.4 oz grape
PRINCIPAL DISPLAY PANEL - Orange Cream 4.4 oz orange cream
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.MANUFACTURED FOR Manufactured for: Sultan Healthcare 1301 Smile Way • York, PA 17404 • USA T oll Free: 800-637-8582 • Phone: 201-871-1232 Fax: 201-871-0321 • www.sultanhealthcare.com Made in USA
Storage and handling
Information about safe storage and handling of the drug product.STORAGE AND HANDLING Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) [See USP Controlled room temperature.]
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