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

  • NDC Code(s): 50227-3211-6, 50227-3221-6, 50227-3231-6, 50227-3241-6, view more
    50227-3251-6, 50227-3261-6, 50227-3271-6, 50227-3281-6
  • Packager: Patterson Dental Supply Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 10/12

If you are a consumer or patient please visit this version.

  • INDICATIONS

    For topical application to aid in the protection against dental caries.

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  • CONTAINS

    Fluoride (Sodium Fluoride) – 1.23% w/w.

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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.

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  • CAUTION

    For Professional Office use only. This product is not intended for home or unsupervised consumer use.

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  • WARNING

    Keep out of reach of children. If more than is used for a fluoride application is swallowed, get medical help or contact a Poison Control Center right away.

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  • HOW SUPPLIED

    Store at controlled room temperature:

    68-77°F (20-25°C). Prevent from freezing.

    Shake well before each use.

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  • SPL UNCLASSIFIED SECTION

    Made in U.S.A.

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  • PRINCIPAL DISPLAY PANEL - 454 g Mint Bottle Label

    PATTERSON
    DENTAL

    NDC# 50227-3221-6

    60-Second
    Fluoride Gel

    (APF*)
    *Acidulated Phosphate Fluoride
    1.23% F Ion

    MINT

    NET WT. 16 OZ

    Reorder Number
    088-4288

    Manufactured for:
    PATTERSON
    DENTAL
    Patterson Dental Supply, Inc.
    1031 Mendota Heights Road
    Saint Paul, MN 55120

    Principal Display Panel - 454 g Mint Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 454 g Grape Bottle Label

    PATTERSON
    DENTAL

    NDC# 50227-3231-6

    60-Second
    Fluoride Gel

    (APF*)
    *Acidulated Phosphate Fluoride
    1.23% F Ion

    GRAPE

    NET WT. 16 OZ

    Reorder Number
    088-4296

    Manufactured for:
    PATTERSON
    DENTAL
    Patterson Dental Supply, Inc.
    1031 Mendota Heights Road
    Saint Paul, MN 55120

    Principal Display Panel - 454 g Grape Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 454 g Bubble Gum Bottle Label

    PATTERSON
    DENTAL

    NDC# 50227-3251-6

    60-Second
    Fluoride Gel

    (APF*)
    *Acidulated Phosphate Fluoride
    1.23% F Ion

    BUBBLE GUM

    NET WT. 16 OZ

    Reorder Number
    088-4247

    Manufactured for:
    PATTERSON
    DENTAL
    Patterson Dental Supply, Inc.
    1031 Mendota Heights Road
    Saint Paul, MN 55120

    Principal Display Panel - 454 g Bubble Gum Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 454 g Strawberry Bottle Label

    PATTERSON
    DENTAL

    NDC# 50227-3281-6

    60-Second
    Fluoride Gel

    (APF*)
    *Acidulated Phosphate Fluoride
    1.23% F Ion

    STRAWBERRY

    NET WT. 16 OZ

    Reorder Number
    088-4270

    Manufactured for:
    PATTERSON
    DENTAL
    Patterson Dental Supply, Inc.
    1031 Mendota Heights Road
    Saint Paul, MN 55120

    Principal Display Panel - 454 g Strawberry Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 454 g Orange Cream Bottle Label

    PATTERSON
    DENTAL

    NDC# 50227-3271-6

    60-Second
    Fluoride Gel

    (APF*)
    *Acidulated Phosphate Fluoride
    1.23% F Ion

    ORANGE CREAM

    NET WT. 16 OZ

    Reorder Number
    088-4262

    Manufactured for:
    PATTERSON
    DENTAL
    Patterson Dental Supply, Inc.
    1031 Mendota Heights Road
    Saint Paul, MN 55120

    Principal Display Panel - 454 g Orange Cream Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 454 g Marshmallow Bottle Label

    PATTERSON
    DENTAL

    NDC# 50227-3261-6

    60-Second
    Fluoride Gel

    (APF*)
    *Acidulated Phosphate Fluoride
    1.23% F Ion

    MARSHMALLOW

    NET WT. 16 OZ

    Reorder Number
    088-4254

    Manufactured for:
    PATTERSON
    DENTAL
    Patterson Dental Supply, Inc.
    1031 Mendota Heights Road
    Saint Paul, MN 55120

    Principal Display Panel - 454 g Marshmallow Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 454 g Cherry Bottle Label

    PATTERSON
    DENTAL

    NDC# 50227-3211-6

    60-Second
    Fluoride Gel

    (APF*)
    *Acidulated Phosphate Fluoride
    1.23% F Ion

    CHERRY

    NET WT. 16 OZ

    Reorder Number
    088-4353

    Manufactured for:
    PATTERSON
    DENTAL
    Patterson Dental Supply, Inc.
    1031 Mendota Heights Road
    Saint Paul, MN 55120

    PRINCIPAL DISPLAY PANEL - 454 g Cherry Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 454 g Piña Colada Bottle Label

    PATTERSON
    DENTAL

    NDC# 50227-3241-6

    60-Second
    Fluoride Gel

    (APF*)
    *Acidulated Phosphate Fluoride
    1.23% F Ion

    PIÑA COLADA

    NET WT. 16 OZ

    Reorder Number
    088-4346

    Manufactured for:
    PATTERSON
    DENTAL
    Patterson Dental Supply, Inc.
    1031 Mendota Heights Road
    Saint Paul, MN 55120

    PRINCIPAL DISPLAY PANEL - 454 g Piña Colada Bottle Label
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  • INGREDIENTS AND APPEARANCE
    60-SECOND FLUORIDE   MINT
    sodium fluoride gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3221
    Route of Administration DENTAL DEA Schedule     
    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 gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3231
    Route of Administration DENTAL DEA Schedule     
    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 gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3251
    Route of Administration DENTAL DEA Schedule     
    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 gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3281
    Route of Administration DENTAL DEA Schedule     
    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 gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3271
    Route of Administration DENTAL DEA Schedule     
    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 gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3261
    Route of Administration DENTAL DEA Schedule     
    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 gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3211
    Route of Administration DENTAL DEA Schedule     
    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 gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50227-3241
    Route of Administration DENTAL DEA Schedule     
    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)
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