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.

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Nupro Fluorides
Sodium Fluoride 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 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

Tropical bottle

PRINCIPAL DISPLAY PANEL - Mint

Mint bottle

PRINCIPAL DISPLAY PANEL - Berry Cherry

berry cherry bottle

PRINCIPAL DISPLAY PANEL - Peach

Peach bottle

NUPRO FLUORIDES   TROPICAL
sodium fluoride rinse
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-034
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)  
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
ColorORANGEScore    
ShapeSize
FlavorORANGE (Tropical) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65222-034-641863 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/197409/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/197409/23/2023
NUPRO FLUORIDES   MINT
sodium fluoride rinse
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-036
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)  
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
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65222-036-641863 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/197410/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/197410/06/2023
NUPRO FLUORIDES   BERRY CHERRY
sodium fluoride rinse
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-038
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)  
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
ColorREDScore    
ShapeSize
FlavorBERRY (Berry Cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65222-038-641863 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/197407/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/197407/16/2023
NUPRO FLUORIDES   PEACH
sodium fluoride rinse
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65222-040
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
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
ColorORANGE (Peach) Score    
ShapeSize
FlavorPEACHImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65222-040-641863 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/197407/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/197407/16/2023
Labeler - Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" (144140845)
Establishment
NameAddressID/FEIBusiness Operations
Dentsply Caulk083235549MANUFACTURE(65222-034, 65222-036, 65222-038, 65222-040)

Revised: 1/2022
Document Id: 77f1bd3b-7f25-4d36-af9f-60760bc699fd
Set id: 615377b0-5682-1ba2-e053-2991aa0a096c
Version: 3
Effective Time: 20220118
 
Dentsply LLC. Professional Division Trading as "DENTSPLY Professional"