Indications
For topical application to aid in the protection against dental caries.
60-second Fluoride
FDA Label NDC 50227-3261
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Patterson Dental Supply Inc for the product 60-second Fluoride (NDC 50227-3261). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications, contains, dosage & administration, caution, warning, storage and handling, other, principal display panel - 454 g mint bottle label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Storage And Handling
Store at controlled room temperature:
68-77°F (20-25°C). Prevent from freezing.
Shake well before each use.
Other
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)
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