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

Nupro Fluorides by

Drug Labeling and Warnings

Nupro Fluorides by is a Prescription medication manufactured, distributed, or labeled by Dentsply LLC. Professional Division Trading as "DENTSPLY Professional", Dentsply Caulk. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

NUPRO FLUORIDES  TROPICAL
sodium fluoride rinse

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 65222-034
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65222-034-64	1863 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/1900

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/1900

NUPRO FLUORIDES  MINT
sodium fluoride rinse

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 65222-036
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65222-036-64	1863 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/1900

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/1900

NUPRO FLUORIDES  BERRY CHERRY
sodium fluoride rinse

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 65222-038
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65222-038-64	1863 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/1900

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/1900

NUPRO FLUORIDES  PEACH
sodium fluoride rinse

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 65222-040
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65222-040-64	1863 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/1900

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/1900

Labeler - Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" (144140845)

Establishment
Name	Address	ID/FEI	Business Operations
Dentsply Caulk		083235549	manufacture(65222-034, 65222-036, 65222-038, 65222-040)