Gelato Neutral Sodium Fluoride Gel
Generic Name: sodium fluoride
Dosage Form: gel
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.
For further information about unapproved drugs, click here. Inactive Ingredients
Flavor, Phosphoric Acid, Sodium Saccharine, Xylitol, Citric Acid, Sodium Benzoate, Water, Titanium Dioxide, Polysorbate 20, Xantham Gum, Magnesium Aluminum Silicate, Potassium Hydroxide.
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 preventive caries treatment 2 times a year.
After thorough prophylaxis, fill two single or one dual tray one third full with gel. Air dry teeth and insert trays into the mouth.
Instruct patient to bite down lightly but firmly for FOUR MINUTES.
Remove trays. Instruct patient to expectorate any exces gel and not to eat or drink for at least 30 minutes.
Indications and Usage
This is a prescription fluoride treatment gel used to help prevent dental decay.
Store at controlled room temperature 50° - 86° F (15° - 30° C)
Protect from freezing
Sodium Fluoride 2%
GELATO NEUTRAL PH DYE FREE MINT
sodium fluoride gel
HUMAN PRESCRIPTION DRUG LABEL
Item Code (Source)
Route of Administration
DENTAL, TOPICAL, ORAL
Active Ingredient/Active Moiety
Basis of Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE
2 mL in 100 mL
CITRIC ACID MONOHYDRATE
MAGNESIUM ALUMINUM SILICATE
480 mL in 1 BOTTLE
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
unapproved drug other
Labeler - Deepak Products, inc. (124886743)
Deepak Products, inc.
Deepak Products, inc.
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