ZAP NEUTRAL- sodium fluoride gel

Zap Neutral by

Drug Labeling and Warnings

Zap Neutral by is a Prescription medication manufactured, distributed, or labeled by Crosstex International Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZAP NEUTRAL 
sodium fluoride gel

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	4.086 g  in 454 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Phosphoric Acid (UNII: E4GA8884NN)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sodium Benzoate (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)
Xylitol (UNII: VCQ006KQ1E)
Titanium Dioxide (UNII: 15FIX9V2JP)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24794-108-16	454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018

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)