Nupro Fluorides NaF Oral Solution Mint

NUPRO FLUORIDES NAF ORAL SOLUTION MINT- sodium fluoride gel
NUPRO FLUORIDES NAF ORAL SOLUTION APPLE CINNAMON- sodium fluoride gel
NUPRO FLUORIDES NAF ORAL SOLUTION MANDARIN ORANGE- sodium fluoride gel
Dentsply LLC. Professional Division Trading as “DENTSPLY Professional”

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

NUPRO FLUORIDES NAF ORAL SOLUTION MINT sodium fluoride gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65222-401 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 20 mg in 1 g

Inactive Ingredients Ingredient Name Strength 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

Product Characteristics Color GREEN Score Shape Size Flavor MINT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65222-401-32 7 g in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1974

NUPRO FLUORIDES NAF ORAL SOLUTION APPLE CINNAMON sodium fluoride gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65222-421 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 20 mg in 1 g

Inactive Ingredients Ingredient Name Strength 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

Product Characteristics Color GREEN Score Shape Size Flavor APPLE (Apple Cinnamon) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65222-421-32 7 g in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1974

NUPRO FLUORIDES NAF ORAL SOLUTION MANDARIN ORANGE sodium fluoride gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65222-411 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 20 mg in 1 g

Inactive Ingredients Ingredient Name Strength 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

Product Characteristics Color ORANGE Score Shape Size Flavor ORANGE (Mandarin Orange) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65222-411-32 7 g in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1974

Labeler — Dentsply LLC. Professional Division Trading as “DENTSPLY Professional” (144140845)

Establishment
Name	Address	ID/FEI	Operations
Dentsply Caulk		083235549	MANUFACTURE (65222-401), MANUFACTURE (65222-411), MANUFACTURE (65222-421)

Revised: 01/2022 Dentsply LLC. Professional Division Trading as “DENTSPLY Professional”