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Zap Neutral (Gelato sodium fluoride) Package Insert

Status:
Prescription (Rx) Facts
Strength:
4.086 g/454 g
Brand names:
Active ingredient:
Similar drugs:

Prescribing information (package insert) - Zap Neutral

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. 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. 2. Instruct patient to bite down lightly but firmly four minutes.
  3. 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.

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Zap Neutral

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Sodium fluoride 4.086 g/454 g
Dosage form Gel
Route Dental
Marketing status listed in the FDA NDC Directory
Company (applicant) Crosstex International Inc.
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
4.086 g/454 g – 454 g in 1 bottle, plastic NDC 24794-108-16

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.