Indications and uses
For topical application to aid in the protection against dental caries.
For topical application to aid in the protection against dental caries.
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 ...
Store at room temperature. Protect from freezing.
For topical application to aid in the protection against dental caries.
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.
Hypersensitivity to fluoride.
Do not swallow. Keep out of reach of children.
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. Laboratory studies have indicated that repeated use of APF may dull porcelain, composite restorations and sealants.
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.
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.
2.59% sodium fluoride (1.23% fluoride ion) gel supplied in 12 fl. oz. bottles.
Store at room temperature. Protect from freezing.
SAFETY DATA SHEET is available on our website,
www.dentsplysirona.com, or by contacting Customer Service at 1-800-989-8826.
Manufactured For:
DENTSPLY Professional
1301 Smile Way
York, PA 17404 USA
1-800-989-8826
Made in the U.S.A
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65222-431-44 | 2020-07-27 | C162847 | 48780-1 | ab0e2407-3428-f274-e053-dbdaa90a6471 | Nupro® Fluorides Acidulated Phosphate Fluoride (APF) Topical Gel |
| 65222-451-44 | 2020-07-27 | C162847 | 48780-1 | ab0e2407-3428-f274-e053-dbdaa90a6471 | Nupro® Fluorides Acidulated Phosphate Fluoride (APF) Topical Gel |
| 65222-431-44 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3428-f274-e053-dbdaa90a6471 | Nupro® Fluorides Acidulated Phosphate Fluoride (APF) Topical Gel |
| 65222-451-44 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3428-f274-e053-dbdaa90a6471 | Nupro® Fluorides Acidulated Phosphate Fluoride (APF) Topical Gel |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65222-431 | 65222-431-44 |
| 65222-451 | 65222-451-44 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 43c5ec5b-ea38-49f3-a473-7dc8b6c232c9 | 6154542f-4ea4-7155-e053-2991aa0ad998 | 2022-01-24 | Warnings, Adverse reactions | 6154542f-4ea4-7155-e053-2991aa0ad998 |
Adverse event summaries are temporarily unavailable. Other product information remains available.