Nupro Fluorides Tropical

NUPRO FLUORIDES TROPICAL- sodium fluoride rinse
NUPRO FLUORIDES MINT- sodium fluoride rinse
NUPRO FLUORIDES BERRY CHERRY- sodium fluoride rinse
NUPRO FLUORIDES PEACH- sodium fluoride rinse
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 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

NUPRO FLUORIDES TROPICAL sodium fluoride rinse

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65222-034 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 SACCHARIN SODIUM METHYLPARABEN BENZOIC ACID XANTHAN GUM FD&C RED NO. 40 WATER FD&C YELLOW NO. 6

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65222-034-64 1863 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 MINT sodium fluoride rinse

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65222-036 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 SACCHARIN SODIUM METHYLPARABEN BENZOIC ACID XANTHAN GUM FD&C BLUE NO. 1 WATER

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65222-036-64 1863 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 BERRY CHERRY sodium fluoride rinse

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65222-038 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 SACCHARIN SODIUM METHYLPARABEN BENZOIC ACID XANTHAN GUM FD&C RED NO. 40 WATER

Product Characteristics Color RED Score Shape Size Flavor BERRY (Berry Cherry) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65222-038-64 1863 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 PEACH sodium fluoride rinse

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65222-040 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 FD&C YELLOW NO. 6 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SACCHARIN SODIUM METHYLPARABEN BENZOIC ACID XANTHAN GUM FD&C RED NO. 40 WATER

Product Characteristics Color ORANGE (Peach) Score Shape Size Flavor PEACH Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65222-040-64 1863 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 (65222-034), MANUFACTURE (65222-036), MANUFACTURE (65222-038), MANUFACTURE (65222-040)

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