Label: 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
- NDC Code(s): 65222-401-32, 65222-411-32, 65222-421-32
- Packager: Dentsply LLC. Professional Division Trading as "DENTSPLY Professional"
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated January 18, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS AND USAGE
-
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
- WARNINGS AND PRECAUTIONS
- OVERDOSAGE
- ADVERSE REACTIONS
- HOW SUPPLIED
- STORAGE
- SDS WARNINGS
- MANUFACTURED FOR
- 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 gelProduct 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 01/01/1974 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1974 NUPRO FLUORIDES NAF ORAL SOLUTION APPLE CINNAMON
sodium fluoride gelProduct 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 01/01/1974 04/07/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1974 04/07/2023 NUPRO FLUORIDES NAF ORAL SOLUTION MANDARIN ORANGE
sodium fluoride gelProduct 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 01/01/1974 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 Business Operations Dentsply Caulk 083235549 MANUFACTURE(65222-401, 65222-411, 65222-421)