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60-Second Fluoride Gel

Generic Name: sodium fluoride
Dosage Form: gel

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.

60-Second Fluoride Gel

INDICATIONS

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

CONTAINS

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

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

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

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.

Store at controlled room temperature:

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

Shake well before each use.

Made in U.S.A.

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 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 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 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 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 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 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 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

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
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
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
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
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
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
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
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
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)
Revised: 10/2012
 
Patterson Dental Supply Inc



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