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NDC 24794-0103-16 Zap APF 5.6 g/454g Details

Zap APF 5.6 g/454g

Zap APF is a DENTAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Crosstex International Inc.. The primary component is SODIUM FLUORIDE.

MedlinePlus Drug Summary

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 24794-0103-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	24794-0103
Product ID	24794-103_d61895e1-6f77-4d3d-e053-2995a90a1729
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Zap APF
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium Fluoride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	GEL
Route	DENTAL
Active Ingredient Strength	5.6
Active Ingredient Units	g/454g
Substance Name	SODIUM FLUORIDE
Labeler Name	Crosstex International Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 24794-0103-16 (24794010316)

Pricing Information	N/A
NDC Package Code	24794-103-16
Billing NDC	24794010316
Package	454 g in 1 BOTTLE, PLASTIC (24794-103-16)
Marketing Start Date	2018-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ec50b003-cf61-4f66-bb62-f779e48363c2 Details

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:

Anticaries Treatment.

Indications and 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 not 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:24794-103
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	5.6 g in 454 g

Ingredient Name	Strength
Inactive Ingredients
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	MARSHMALLOW	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24794-103-16	454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018

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

Labeler - Crosstex International Inc. (057728685)

Revised: 1/2022

Document Id: d61895e1-6f77-4d3d-e053-2995a90a1729

Set id: ec50b003-cf61-4f66-bb62-f779e48363c2

Version: 5

Effective Time: 20220121