Nupro® Fluorides Acidulated Phosphate Fluoride (APF) Topical Gel

Manufacturer
Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" | Dentsply Caulk
Effective date
2022-01-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:11:58

Label at a glance#

ProductNupro Fluorides Wild Cherry
Active ingredientSODIUM FLUORIDE
Label structure12 sections

Indications and uses

For topical application to aid in the protection against dental caries.

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 ...

Storage and handling

Store at room temperature. Protect from freezing.

Label contents#

Full prescribing information#

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For topical application to aid in the protection against dental caries.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

CONTRAINDICATIONS SECTION

Hypersensitivity to fluoride.

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

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.

OVERDOSAGE

OVERDOSAGE SECTION

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

ADVERSE REACTIONS SECTION

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

HOW SUPPLIED SECTION

2.59% sodium fluoride (1.23% fluoride ion) gel supplied in 12 fl. oz. bottles.

STORAGE

STORAGE AND HANDLING SECTION

Store at room temperature. Protect from freezing.

SDS WARNINGS

SPL UNCLASSIFIED SECTION

SAFETY DATA SHEET is available on our website, www.dentsplysirona.com, or by contacting Customer Service at 1-800-989-8826.

SDS warningSDS warning

MANUFACTURED FOR

SPL UNCLASSIFIED SECTION

Manufactured For:
DENTSPLY Professional
1301 Smile Way
York, PA 17404 USA
1-800-989-8826

Made in the U.S.A

PRINCIPAL DISPLAY PANEL - Wild Cherry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

wild cherrywild cherry

PRICIPAL DISPLAY PANEL - Bubble Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bubble gumbubble gum

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65222-43165222-431-44
65222-45165222-451-44

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML · Source PDF

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
43c5ec5b-ea38-49f3-a473-7dc8b6c232c96154542f-4ea4-7155-e053-2991aa0ad9982022-01-24Warnings, Adverse reactionsExact identifier
spl set id: 6154542f-4ea4-7155-e053-2991aa0ad998

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.