ZAP APF- sodium fluoride gel

Zap APF by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient:

Fluoride Ion 1.23%. A stable thixotropic gel providing 1.23% fluoride ion. Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.

Purpose:

Anitcaries Treatment.

Indications & Usage:

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

• For Professional Use Only. This product is not intended for home or unsupervised consumer 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 above 25°C/77°F.
• Do no freeze.

Inactive Ingredients:

Citric Acid, FD&C Red #40, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZAP APF 
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 24794-100
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	5.6 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 RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24794-100-16	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)