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 

  • Label RSS
  • 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 LABEL Item Code (Source) NDC:50227-3221
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Fluoride Ion 12.3 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    MAGNESIUM ALUMINUM SILICATE  
    Phosphoric Acid  
    Hydrofluoric Acid  
    Anhydrous Citric Acid  
    Xanthan Gum  
    Xylitol  
    Polysorbate 20  
    SACCHARIN SODIUM DIHYDRATE  
    Sodium Benzoate  
    Titanium Dioxide  
    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 LABEL Item Code (Source) NDC:50227-3231
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Fluoride Ion 12.3 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    MAGNESIUM ALUMINUM SILICATE  
    Phosphoric Acid  
    Hydrofluoric Acid  
    Anhydrous Citric Acid  
    Xanthan Gum  
    Xylitol  
    Polysorbate 20  
    SACCHARIN SODIUM DIHYDRATE  
    Sodium Benzoate  
    Titanium Dioxide  
    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 LABEL Item Code (Source) NDC:50227-3251
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Fluoride Ion 12.3 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    MAGNESIUM ALUMINUM SILICATE  
    Phosphoric Acid  
    Hydrofluoric Acid  
    Anhydrous Citric Acid  
    Xanthan Gum  
    Xylitol  
    Polysorbate 20  
    SACCHARIN SODIUM DIHYDRATE  
    Sodium Benzoate  
    Titanium Dioxide  
    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 LABEL Item Code (Source) NDC:50227-3281
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Fluoride Ion 12.3 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    MAGNESIUM ALUMINUM SILICATE  
    Phosphoric Acid  
    Hydrofluoric Acid  
    Anhydrous Citric Acid  
    Xanthan Gum  
    Xylitol  
    Polysorbate 20  
    SACCHARIN SODIUM DIHYDRATE  
    Sodium Benzoate  
    Titanium Dioxide  
    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 LABEL Item Code (Source) NDC:50227-3271
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Fluoride Ion 12.3 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    MAGNESIUM ALUMINUM SILICATE  
    Phosphoric Acid  
    Hydrofluoric Acid  
    Anhydrous Citric Acid  
    Xanthan Gum  
    Xylitol  
    Polysorbate 20  
    SACCHARIN SODIUM DIHYDRATE  
    Sodium Benzoate  
    Titanium Dioxide  
    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 LABEL Item Code (Source) NDC:50227-3261
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Fluoride Ion 12.3 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    MAGNESIUM ALUMINUM SILICATE  
    Phosphoric Acid  
    Hydrofluoric Acid  
    Anhydrous Citric Acid  
    Xanthan Gum  
    Xylitol  
    Polysorbate 20  
    SACCHARIN SODIUM DIHYDRATE  
    Sodium Benzoate  
    Titanium Dioxide  
    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 LABEL Item Code (Source) NDC:50227-3211
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Fluoride Ion 12.3 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    MAGNESIUM ALUMINUM SILICATE  
    Phosphoric Acid  
    Hydrofluoric Acid  
    Anhydrous Citric Acid  
    Xanthan Gum  
    Xylitol  
    Polysorbate 20  
    SACCHARIN SODIUM DIHYDRATE  
    Sodium Benzoate  
    Titanium Dioxide  
    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 LABEL Item Code (Source) NDC:50227-3241
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Fluoride Ion 12.3 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    MAGNESIUM ALUMINUM SILICATE  
    Phosphoric Acid  
    Hydrofluoric Acid  
    Anhydrous Citric Acid  
    Xanthan Gum  
    Xylitol  
    Polysorbate 20  
    SACCHARIN SODIUM DIHYDRATE  
    Sodium Benzoate  
    Titanium Dioxide  
    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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