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  5. Label Information: Zap Neutral

FDA Label for Zap Neutral

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

Zap Neutral Product Label

The following document was submitted to the FDA by the labeler of this product Crosstex International Inc.. 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:



Sodium Fluoride 2% (0.9% Fluoride Ion)


Purpose:



Anticaries Treatment.


Indications And Usage:



This is a prescription fluoride treatment gel used to help prevent dental decay.


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.
  • This product contains a concentrated fluoride amount and is available by prescription only. It should be used under professional supervision.

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 four minutes.

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 above 25°C/77°F.
Do not freeze.


Inactive Ingredients:



Citric Acid, FD&C Green #3, FD&C Yellow #5 (tartrazine) as a color additive, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.


* Please review the disclaimer below.