FDA Label for Nupro Fluorides Naf Oral Solution Mandarin Orange
View Indications, Usage & Precautions
Nupro Fluorides Naf Oral Solution Mandarin Orange Product Label
The following document was submitted to the FDA by the labeler of this product Dentsply Llc. Professional Division Trading As "dentsply Professional". The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
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.
May contain FD&C Yellow No. 6.
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.
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
2.0% sodium fluoride (0.9% 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.
Manufactured For
Manufactured For:
DENTSPLY Professional
1301 Smile Way
York, PA 17404 USA
1-800-989-8826
Made in USA.
Principal Display Panel - Mandarin Orange
Principal Display Panel - Mint
Principal Display Panel - Apple Cinnamon
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