Your browser does not support JavaScript! 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 [PATTERSON DENTAL SUPPLY INC]
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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
[Patterson Dental Supply Inc]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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 Sections

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 Mint Bottle Label

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

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

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

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

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

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

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
60-SECOND FLUORIDE   MINT
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50227-3221
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion12.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50227-3221-6454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/1978
60-SECOND FLUORIDE   GRAPE
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50227-3231
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion12.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50227-3231-6454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/197810/01/2012
60-SECOND FLUORIDE   BUBBLE GUM
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50227-3251
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion12.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50227-3251-6454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/1978
60-SECOND FLUORIDE   STRAWBERRY
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50227-3281
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion12.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50227-3281-6454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/197810/01/2012
60-SECOND FLUORIDE   ORANGE CREAM
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50227-3271
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion12.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScore    
ShapeSize
FlavorORANGE (Orange Cream) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50227-3271-6454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/1978
60-SECOND FLUORIDE   MARSHMALLOW
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50227-3261
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion12.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOWScore    
ShapeSize
FlavorMARSHMALLOWImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50227-3261-6454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/197810/01/2012
60-SECOND FLUORIDE   CHERRY
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50227-3211
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion12.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50227-3211-6454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/1978
60-SECOND FLUORIDE   PINA COLADA
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50227-3241
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion12.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorCOCONUT (Pina Colada) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50227-3241-6454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/1978
Labeler - Patterson Dental Supply Inc (171843584)

Revised: 10/2012
 
Patterson Dental Supply Inc

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