Zap Neutral

Name: Zap Neutral

Active Ingredient

Sodium Fluoride 2%

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.

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.

Zap Neutral 
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24794-108
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 4.086 g  in 454 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
Magnesium Aluminum Silicate  
Phosphoric Acid  
Polysorbate 20  
Sodium Benzoate  
SACCHARIN SODIUM  
Water  
Xanthan Gum  
Xylitol  
Titanium Dioxide  
FD&C GREEN NO. 3  
FD&C YELLOW NO. 5  
Product Characteristics
Color green Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:24794-108-16 454 g in 1 BOTTLE, PLASTIC
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)
Revised: 10/2014   Crosstex International Inc.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to fluoride topical: mucous membrane powder for reconstitution, mucous membrane solution, topical cream, topical gel, topical kit, topical paste, topical solution, topical swab

Hypersensitivity

Hypersensitivity side effects including allergic reactions have been reported.[Ref]

Oncologic

It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and animal cells at doses much higher than those to which humans are exposed. In vivo data are conflicting.[Ref]

Some side effects of Zap Neutral may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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