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Zap Neutral Prescribing Information

Package insert / product label
Generic name: sodium fluoride
Dosage form: gel
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Mar 1, 2024.

Active Ingredient:

Sodium Fluoride 2% (0.9% Fluoride Ion)

Purpose:

Anticaries Treatment.

Indications and Usage for Zap Neutral

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.

Zap Neutral 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.

Storage and Handling

  • 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.

LB.ZAP APF_Neutral Mint Rev 5.jpg

ZAP NEUTRAL
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24794-108
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION4.086 g in 454 g
Inactive Ingredients
Ingredient NameStrength
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
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)
Product Characteristics
ColorgreenScore
ShapeSize
FlavorMINTImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24794-108-16454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/14/2012
Labeler - Crosstex International Inc. (057728685)