Gelato Neutral PH Dye Free Mint

GELATO NEUTRAL PH DYE FREE MINT — sodium fluoride gel
Deepak Products, inc.

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.

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.

Gelato Neutral PH Dye Free Mint 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%

Entire Label
(click image for full-size original)

GELATO NEUTRAL PH DYE FREE MINT
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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
# Item Code Package Description Multilevel Packaging
1 NDC: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: 02/2010 Deepak Products, inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.