Label: 60-SECOND FLUORIDE MINT- sodium fluoride gel
60-SECOND FLUORIDE GRAPE- sodium fluoride gel
60-SECOND FLUORIDE BUBBLE GUM- sodium fluoride gel
60-SECOND FLUORIDE STRAWBERRY- sodium fluoride gel
60-SECOND FLUORIDE ORANGE CREAM- sodium fluoride gel
60-SECOND FLUORIDE MARSHMALLOW- sodium fluoride gel
60-SECOND FLUORIDE CHERRY- sodium fluoride gel
60-SECOND FLUORIDE PINA COLADA- sodium fluoride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50227-3211-6, 50227-3221-6, 50227-3231-6, 50227-3241-6, view more50227-3251-6, 50227-3261-6, 50227-3271-6, 50227-3281-6 - Packager: Patterson Dental Supply Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
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 October 9, 2012
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS
- CONTAINS
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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
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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)
