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.

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Nupro® Fluorides
Neutral Sodium Fluoride (NaF) Oral Solution

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.

warning icons

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

mandarin orange

PRINCIPAL DISPLAY PANEL - Mint

mint bottle

PRINCIPAL DISPLAY PANEL - Apple Cinnamon

apple cinnamon

NUPRO FLUORIDES NAF ORAL SOLUTION   MINT
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-401
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65222-401-327 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/1974
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/1974
NUPRO FLUORIDES NAF ORAL SOLUTION   APPLE CINNAMON
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-421
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorGREENScore    
ShapeSize
FlavorAPPLE (Apple Cinnamon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65222-421-327 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/197404/07/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/197404/07/2023
NUPRO FLUORIDES NAF ORAL SOLUTION   MANDARIN ORANGE
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-411
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScore    
ShapeSize
FlavorORANGE (Mandarin Orange) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65222-411-327 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/1974
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/1974
Labeler - Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" (144140845)
Establishment
NameAddressID/FEIBusiness Operations
Dentsply Caulk083235549MANUFACTURE(65222-401, 65222-411, 65222-421)

Revised: 1/2022
Document Id: b42b2479-5edc-4ccb-b59d-96cd153dfe71
Set id: 6155acd9-8ec1-a87d-e053-2991aa0a7b43
Version: 3
Effective Time: 20220118
 
Dentsply LLC. Professional Division Trading as "DENTSPLY Professional"