Gelato neutral ph gel

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 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 infomation:

Do not store above 25C/77F. 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.

Ingredients and appearance - Product information

Gelato neutral ph gel- Sodium fluoride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68400-136
Route of Administration Dental

Active Ingredient/Active Moiety

Ingredient Name Strength
Sodium fluoride ( UNII: 8ZYQ1474W7)( Fluoride ion - UNII: Q80VPU408O ) 4.086 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)
Potassium hydroxide ( UNII: WZH3C48M4T)
Sodium benzoate ( UNII: OJ245FE5EU)
Saccharin sodium ( UNII: SB8ZUX40TY)
Titanium dioxide ( UNII: 15FIX9V2JP)
Water ( UNII: 059QF0KO0R)
Xanthan gum ( UNII: TTV12P4NEE)
Xylitol ( UNII: VCQ006KQ1E)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c green no. 3 ( UNII: 3P3ONR6O1S)
Fd&c red no. 3 ( UNII: PN2ZH5LOQY)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Fd&c yellow no. 5 ( UNII: I753WB2F1M)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)

Product Characteristics

Flavor MINT Color white (Dye Free)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other 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( 68400-136), label( 68400-136)

Package label.principal display panel