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

Nupro Fluorides NaF Oral Solution by

Drug Labeling and Warnings

Nupro Fluorides NaF Oral Solution 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, 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

INGREDIENTS AND APPEARANCE

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

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)
METHYLPARABEN (UNII: A2I8C7HI9T)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65222-401-32	7 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 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

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)
METHYLPARABEN (UNII: A2I8C7HI9T)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65222-421-32	7 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 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

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)
METHYLPARABEN (UNII: A2I8C7HI9T)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65222-411-32	7 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(65222-411, 65222-401, 65222-421)