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| Product NDC Code | 65222-411 | ||||
|---|---|---|---|---|---|
| Drug Name | Nupro fluorides naf oral solution mandarin orange |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 245593, 1993075 |
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| Labeler Name | Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" | ||||
| Packages |
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Overdosage of Nupro Fluorides NaF Oral Solution Mandarin Orange
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, urticaria, 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
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. 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
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 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.
Spl product data elements
Usually a list of ingredients in a drug product.Nupro Fluorides NaF Oral Solution Mint Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM PHOSPHATE, DIBASIC, ANHYDROUS METHYLPARABEN CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) BENZOIC ACID SACCHARIN SODIUM D&C YELLOW NO. 10 XANTHAN GUM SODIUM HYDROXIDE WATER FD&C BLUE NO. 1 Nupro Fluorides NaF Oral Solution Apple Cinnamon Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM PHOSPHATE, DIBASIC, ANHYDROUS METHYLPARABEN FD&C YELLOW NO. 6 CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) BENZOIC ACID SACCHARIN SODIUM D&C YELLOW NO. 10 XANTHAN GUM SODIUM HYDROXIDE WATER FD&C BLUE NO. 1 Apple Cinnamon Nupro Fluorides NaF Oral Solution Mandarin Orange Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM PHOSPHATE, DIBASIC, ANHYDROUS METHYLPARABEN FD&C YELLOW NO. 6 CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) BENZOIC ACID SACCHARIN SODIUM FD&C RED NO. 40 XANTHAN GUM SODIUM HYDROXIDE WATER Mandarin Orange
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 - Mandarin Orange mandarin orange
PRINCIPAL DISPLAY PANEL - Mint mint bottle
PRINCIPAL DISPLAY PANEL - Apple Cinnamon apple cinnamon
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.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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED 2.0% sodium fluoride (0.9% fluoride ion) gel supplied in 12 fl. oz. bottles.
Storage and handling
Information about safe storage and handling of the drug product.STORAGE Store at room temperature. Protect from freezing.
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