| NDC | 50227-3211-6, 50227-3221-6, 50227-3231-6, 50227-3241-6, 50227-3251-6, 50227-3261-6, 50227-3271-6, 50227-3281-6 |
| Set ID | ad3685e0-c6f0-49dd-b638-eec7ec7be795 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Patterson Dental Supply Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- INDICATIONS
- CONTAINS
-
DOSAGE & ADMINISTRATION
Fill fluoride tray with 2-3ml of fluoride gel per arch. Dry tooth surface and insert tray(s) in mouth. Have patient bite down for 60 seconds (or up to 4 minutes). Slight chewing motion provides interproximal coverage. Remove tray(s) and have patient expectorate excess gel. Inform patient not to eat, drink or rinse for 30 minutes.
- CAUTION
- WARNING
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 454 g Mint Bottle Label
- PRINCIPAL DISPLAY PANEL - 454 g Grape Bottle Label
- PRINCIPAL DISPLAY PANEL - 454 g Bubble Gum Bottle Label
- PRINCIPAL DISPLAY PANEL - 454 g Strawberry Bottle Label
- PRINCIPAL DISPLAY PANEL - 454 g Orange Cream Bottle Label
- PRINCIPAL DISPLAY PANEL - 454 g Marshmallow Bottle Label
- PRINCIPAL DISPLAY PANEL - 454 g Cherry Bottle Label
- PRINCIPAL DISPLAY PANEL - 454 g Piña Colada Bottle Label
-
INGREDIENTS AND APPEARANCE
60-SECOND FLUORIDE MINT
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3221 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 12.3 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) Phosphoric Acid (UNII: E4GA8884NN) Hydrofluoric Acid (UNII: RGL5YE86CZ) Anhydrous Citric Acid (UNII: XF417D3PSL) Xanthan Gum (UNII: TTV12P4NEE) Xylitol (UNII: VCQ006KQ1E) Polysorbate 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) Sodium Benzoate (UNII: OJ245FE5EU) Titanium Dioxide (UNII: 15FIX9V2JP) 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:50227-3221-6 454 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1978 60-SECOND FLUORIDE GRAPE
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3231 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 12.3 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) Phosphoric Acid (UNII: E4GA8884NN) Hydrofluoric Acid (UNII: RGL5YE86CZ) Anhydrous Citric Acid (UNII: XF417D3PSL) Xanthan Gum (UNII: TTV12P4NEE) Xylitol (UNII: VCQ006KQ1E) Polysorbate 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) Sodium Benzoate (UNII: OJ245FE5EU) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50227-3231-6 454 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1978 10/01/2012 60-SECOND FLUORIDE BUBBLE GUM
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3251 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 12.3 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) Phosphoric Acid (UNII: E4GA8884NN) Hydrofluoric Acid (UNII: RGL5YE86CZ) Anhydrous Citric Acid (UNII: XF417D3PSL) Xanthan Gum (UNII: TTV12P4NEE) Xylitol (UNII: VCQ006KQ1E) Polysorbate 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) Sodium Benzoate (UNII: OJ245FE5EU) Titanium Dioxide (UNII: 15FIX9V2JP) 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:50227-3251-6 454 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1978 60-SECOND FLUORIDE STRAWBERRY
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3281 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 12.3 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) Phosphoric Acid (UNII: E4GA8884NN) Hydrofluoric Acid (UNII: RGL5YE86CZ) Anhydrous Citric Acid (UNII: XF417D3PSL) Xanthan Gum (UNII: TTV12P4NEE) Xylitol (UNII: VCQ006KQ1E) Polysorbate 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) Sodium Benzoate (UNII: OJ245FE5EU) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color PINK Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50227-3281-6 454 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1978 10/01/2012 60-SECOND FLUORIDE ORANGE CREAM
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3271 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 12.3 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) Phosphoric Acid (UNII: E4GA8884NN) Hydrofluoric Acid (UNII: RGL5YE86CZ) Anhydrous Citric Acid (UNII: XF417D3PSL) Xanthan Gum (UNII: TTV12P4NEE) Xylitol (UNII: VCQ006KQ1E) Polysorbate 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) Sodium Benzoate (UNII: OJ245FE5EU) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score Shape Size Flavor ORANGE (Orange Cream) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50227-3271-6 454 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1978 60-SECOND FLUORIDE MARSHMALLOW
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3261 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 12.3 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) Phosphoric Acid (UNII: E4GA8884NN) Hydrofluoric Acid (UNII: RGL5YE86CZ) Anhydrous Citric Acid (UNII: XF417D3PSL) Xanthan Gum (UNII: TTV12P4NEE) Xylitol (UNII: VCQ006KQ1E) Polysorbate 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) Sodium Benzoate (UNII: OJ245FE5EU) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW Score Shape Size Flavor MARSHMALLOW Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50227-3261-6 454 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1978 10/01/2012 60-SECOND FLUORIDE CHERRY
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3211 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 12.3 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) Phosphoric Acid (UNII: E4GA8884NN) Hydrofluoric Acid (UNII: RGL5YE86CZ) Anhydrous Citric Acid (UNII: XF417D3PSL) Xanthan Gum (UNII: TTV12P4NEE) Xylitol (UNII: VCQ006KQ1E) Polysorbate 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) Sodium Benzoate (UNII: OJ245FE5EU) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50227-3211-6 454 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1978 60-SECOND FLUORIDE PINA COLADA
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3241 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 12.3 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) Phosphoric Acid (UNII: E4GA8884NN) Hydrofluoric Acid (UNII: RGL5YE86CZ) Anhydrous Citric Acid (UNII: XF417D3PSL) Xanthan Gum (UNII: TTV12P4NEE) Xylitol (UNII: VCQ006KQ1E) Polysorbate 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) Sodium Benzoate (UNII: OJ245FE5EU) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score Shape Size Flavor COCONUT (Pina Colada) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50227-3241-6 454 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1978 Labeler - Patterson Dental Supply Inc (171843584)
