Gelato Neutral Sodium Fluoride Gel

Dosage Form: gel

Inactive Ingredients

Flavor, Phosphoric Acid, Sodium Saccharine, Xylitol, Citric Acid, Sodium Benzoate, Water, Titanium Dioxide, Polysorbate 20, Xantham Gum, Magnesium Aluminum Silicate, Potassium Hydroxide.

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 preventive caries treatment 2 times a year.

1. After thorough prophylaxis, 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 FOUR MINUTES.


3. 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.

Other Information

• Store at controlled room temperature 50° - 86° F (15° - 30° C)


• Protect from freezing

Active Ingredients

Sodium Fluoride 2%

GELATO NEUTRAL PH DYE FREE MINT  sodium fluoride  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68400-136 Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 2 mL  in 100 mL

Inactive Ingredients Ingredient Name Strength PHOSPHORIC ACID   SACCHARIN SODIUM   XYLITOL   CITRIC ACID MONOHYDRATE   SODIUM BENZOATE   WATER   TITANIUM DIOXIDE   POLYSORBATE 20   XANTHAN GUM   MAGNESIUM ALUMINUM SILICATE   POTASSIUM HYDROXIDE

Product Characteristics Color      Score      Shape Size Flavor MINT Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68400-136-15 480 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/15/2010

Labeler - Deepak Products, inc. (124886743)

Establishment
Name	Address	ID/FEI	Operations
Deepak Products, inc.		124886743	manufacture

Revised: 02/2010Deepak Products, inc.