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Gelato Neutral PH

Generic name: sodium fluoride
Dosage form: dental gel

Medically reviewed by Drugs.com. Last updated on Dec 22, 2020.

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.

Active Ingredient:

Sodium Fluoride 2%

Purpose:

Fluoride Treatment Gel

Indications and Usage:

  • A stable thixotropic fluoride treatment gel used to help prevent dental decay.
  • For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.

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.
  • Read directions carefully before using.

Dosage and Administration:

Shake well before use. This is a four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice 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 excess gel and not to eat or drink for at least 30 minutes.

Other Information:

• Do not store above 25°C/77°F. Do not freeze.

Inactive Ingredients:

Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain blue #1, green#3, red #3, red #40, yellow #5 (tartrazine), yellow #6 as a color additive.

Gelato Neutral PH
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68400-115
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
Magnesium Aluminum Silicate
Phosphoric Acid
Polysorbate 20
Potassium Hydroxide
Sodium Benzoate
SACCHARIN SODIUM
CITRIC ACID MONOHYDRATE
Water
Xanthan Gum
Xylitol
FD&C RED NO. 40
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C RED NO. 3
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
Product Characteristics
Color pink Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:68400-115-15 454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/01/2013
Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)
Registrant - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)
Establishment
Name Address ID/FEI Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. 014769301 manufacture(68400-115), label(68400-115)
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

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