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Zap neutral - Medication Information

Product NDC Code 24794-108
Drug Name

Zap neutral

Type Brand
Active Ingredients
Sodium fluoride 4.086 g/454g
Route DENTAL
Dosage Form GEL
RxCUI drug identifier 245593
Labeler Name Crosstex International Inc.
Packages
Package NDC Code Description
24794-108-16 454 g in 1 bottle, plastic (24794-108-16)
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Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Indications and Usage: This is a prescription fluoride treatment gel used to help prevent dental decay.

Spl product data elements

Usually a list of ingredients in a drug product.
Zap Neutral Sodium Fluoride FD&C GREEN NO. 3 FD&C YELLOW NO. 5 SODIUM FLUORIDE FLUORIDE ION CITRIC ACID MONOHYDRATE MAGNESIUM ALUMINUM SILICATE PHOSPHORIC ACID POLYSORBATE 20 SODIUM BENZOATE SACCHARIN SODIUM WATER XANTHAN GUM XYLITOL TITANIUM DIOXIDE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
LB.ZAP APF_Neutral Mint Rev 5.jpg

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Active Ingredient: Sodium Fluoride 2% (0.9% Fluoride Ion) Purpose: Anticaries Treatment.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information: Do not store above 25°C/77°F. Do not freeze.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API