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  5. Label Information: 60 Second Fluoride Gel

FDA Label for 60 Second Fluoride Gel

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT:
    2. PURPOSE:
    3. INDICATIONS AND USAGE:
    4. WARNINGS:
    5. DOSAGE AND ADMINISTRATION:
    6. OTHER INFORMATION:
    7. INACTIVE INGREDIENTS:
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 Second Fluoride Gel Product Label

The following document was submitted to the FDA by the labeler of this product Darby Dental Supply, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient:



Fluoride Ion 1.23%

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid


Purpose:



Fluoride Treatment Gel


Indications And Usage:



  • A stable thixotropic fluoride treatment gel used to help prevent dental decay.
  • For Professional Use Only. This product is not intended for home or unsupervised use.

Warnings:



  • Keep out of reach of children.
  • Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
  • Read directions carefully before using.

Dosage And Administration:



Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.

2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).

3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.


Other Information:



Do not store 25°C/77°F.  Do not freeze.


Inactive Ingredients:



Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain Blue #1, Green #3, Red #3, Red #40, Yellow #5 (tartazine). Yellow #6 as a color additive.


Package Label.Principal Display Panel



60SecFluorideGel_Label.jpg - 60SecFluorideGel Label

60SecFluorideGel_Label.jpg - 60SecFluorideGel Label


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