| NDC | 65222-034-64, 65222-036-64, 65222-038-64, 65222-040-64 |
| Set ID | 615377b0-5682-1ba2-e053-2991aa0a096c |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- INDICATIONS AND USAGE
-
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
- WARNINGS AND PRECAUTIONS
- OVERDOSAGE
- ADVERSE REACTIONS
- HOW SUPPLIED
- STORAGE
- MANUFACTURED FOR
- 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 rinseProduct 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 rinseProduct 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 rinseProduct 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 rinseProduct 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)
