NDC | 65222-431-44, 65222-451-44 |
Set ID | 6154542f-4ea4-7155-e053-2991aa0ad998 |
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, 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
Do not swallow. Keep out of reach of children.
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. Laboratory studies have indicated that repeated use of APF may dull porcelain, composite restorations and sealants. - OVERDOSAGE
- ADVERSE REACTIONS
- HOW SUPPLIED
- STORAGE
- SDS WARNINGS
- MANUFACTURED FOR
- PRINCIPAL DISPLAY PANEL - Wild Cherry
- PRICIPAL DISPLAY PANEL - Bubble Gum
-
INGREDIENTS AND APPEARANCE
NUPRO FLUORIDES WILD CHERRY
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65222-431 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 25.9 mg in 1 g Inactive Ingredients Ingredient Name Strength HYDROFLUORIC ACID (UNII: RGL5YE86CZ) METHYLPARABEN (UNII: A2I8C7HI9T) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) PHOSPHORIC ACID (UNII: E4GA8884NN) BENZOIC ACID (UNII: 8SKN0B0MIM) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color red Score Shape Size Flavor CHERRY (Wild Cherry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65222-431-44 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 BUBBLE GUM
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65222-451 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 25.9 mg in 1 g Inactive Ingredients Ingredient Name Strength HYDROFLUORIC ACID (UNII: RGL5YE86CZ) METHYLPARABEN (UNII: A2I8C7HI9T) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) PHOSPHORIC ACID (UNII: E4GA8884NN) BENZOIC ACID (UNII: 8SKN0B0MIM) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color pink Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65222-451-44 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(65222-431, 65222-451)