Indications and uses
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.
Nupro Fluorides Sodium Fluoride Oral Solution
- Manufacturer
- Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" | Dentsply Caulk
- Effective date
- 2022-01-18
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:13:30
Label at a glance#
ProductNupro Fluorides Tropical
Active ingredientSODIUM FLUORIDE
Label structure13 sections
Dosage and administration
1. Remove cap from bottle by turning counter-clockwise. 2. Remove induction seal from bottle. DO NOT USE IF SEAL IS BROKEN. 3. Insert [enclosed] pump into bottle and tighten, turning clockwise. 4. Dispense premeasured [approximately 15 mL] fluoride rinse into cup [provided]. 5. Have patient rinse [swish] with fluoride rinse for 30 seconds. Expectorate. 6. Repeat steps 4 & 5. 7. Treatment is complete. 8. Instruct p...
Storage and handling
Store at room temperature. Protect from freezing.
Contacts and useful links#
Label contents#
Full prescribing information#
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 by turning counter-clockwise.
2. Remove induction seal from bottle. DO NOT USE IF SEAL IS BROKEN.
3. Insert [enclosed] pump into bottle and tighten, turning clockwise.
4. Dispense premeasured [approximately 15 mL] fluoride rinse into cup [provided].
5. Have patient rinse [swish] with fluoride rinse for 30 seconds. Expectorate.
6. Repeat steps 4 & 5.
7. Treatment is complete.
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) oral solution supplied in 63 Fl. oz (1863 ml bottles)
STORAGE
Store at room temperature. Protect from freezing.
MANUFACTURED FOR
Manufactured for:
DENTSPLY Professional
1301 Smile Way • York, PA 17404 USA
Toll Free: 800-989-8826
Made in the USA
NRINSEDFU, R0-092017
PRICIPAL DISPLAY PANEL - Tropical
PRINCIPAL DISPLAY PANEL - Mint
PRINCIPAL DISPLAY PANEL - Berry Cherry
PRINCIPAL DISPLAY PANEL - Peach
FDA-Initiated Inactive NDC Indexing#
Products#
Every source-derived product name is available through these pages.
- Nupro Fluorides Tropical
- Sodium Fluoride
- FLUORIDE ION
- SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
- SACCHARIN SODIUM
- METHYLPARABEN
- BENZOIC ACID
- XANTHAN GUM
- FD&C RED NO. 40
- WATER
- FD&C YELLOW NO. 6
- Nupro Fluorides Mint
- FD&C BLUE NO. 1
- Nupro Fluorides Berry Cherry
- Nupro Fluorides Peach
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65222-034 | 65222-034-64 |
| 65222-036 | 65222-036-64 |
| 65222-038 | 65222-038-64 |
| 65222-040 | 65222-040-64 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 77f1bd3b-7f25-4d36-af9f-60760bc699fd | 615377b0-5682-1ba2-e053-2991aa0a096c | 2022-01-18 | Warnings, Adverse reactions | 615377b0-5682-1ba2-e053-2991aa0a096c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.