Gelato x gel

Active ingredient:

Fluoride Ion 1.23%

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid

Purpose:

Anticaries Treatment

Indications and usage:

  • A stable thixotropic fluoride treatment gel used to help prevent dental decay.
  • For professional use only. This product is not intended for home or unsupervised 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 one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two 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 one minute (80% effectiveness) or four minutes (100% effectiveness).
  3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Other information:

  • Store at a controlled room temperature 59-86F (15-30C).
  • Protect from freezing.

Inactive ingredients:

Citric Acid, FD&C Red #40, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol

Ingredients and appearance - Product information

Gelato x gel- Sodium fluoride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68400-604
Route of Administration Dental

Active Ingredient/Active Moiety

Ingredient Name Strength
Sodium fluoride ( UNII: 8ZYQ1474W7)( Fluoride ion - UNII: Q80VPU408O ) 5.6 gin 454 g

Inactive Ingredients

Ingredient Name Code
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)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Flavor BUBBLE GUM Color pink

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
export only USA

Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.( 014769301)

Establishment

Name ID/FEI Business Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. 014769301 manufacture( 68400-604), label( 68400-604)

Package label.principal display panel