Zap Neutral

ZAP NEUTRAL- sodium fluoride gel
Crosstex International Inc.

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.

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 lightly before use. This is a four minute topical 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.

ZAP NEUTRAL sodium fluoride gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24794-108 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 4.086 g in 454 g

Inactive Ingredients Ingredient Name Strength FD&C GREEN NO. 3 FD&C YELLOW NO. 5 CITRIC ACID MONOHYDRATE MAGNESIUM ALUMINUM SILICATE PHOSPHORIC ACID POLYSORBATE 20 SODIUM BENZOATE SACCHARIN SODIUM WATER XANTHAN GUM XYLITOL TITANIUM DIOXIDE

Product Characteristics Color green Score Shape Size Flavor MINT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:24794-108-16 454 g in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/14/2012

Labeler — Crosstex International Inc. (057728685)

Revised: 01/2022 Crosstex International Inc.