Drugplain

Gelato Neutral pH 4.086 g/454g

Sodium Fluoride · GEL · Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

No Recall HistoryCurrently in Shortage
Plain English

Gelato Neutral Ph is a prescription dental gel containing sodium fluoride that helps prevent and treat tooth decay. It is applied directly to the teeth by a dental professional.

Key Facts

Brand Name
Gelato Neutral pH
Generic Name
Sodium Fluoride
NDC Code (Product)
68400-114
Manufacturer
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Strength
4.086 g/454g
Dosage Form
GEL
Route
DENTAL
Marketing Status
Marketing Start
03/01/2013

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pyrexia170 reports
fatigue159 reports
nausea158 reports
vomiting156 reports
pain154 reports
weight increased154 reports
nasopharyngitis152 reports
type 2 diabetes mellitus145 reports
peripheral swelling144 reports
urticaria143 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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.

Dosage & Administration

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.

Warnings

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 Conrol Center right away. Read directions carefully before using.

Frequently Asked Questions

What is Gelato Neutral pH used for?

Gelato Neutral Ph is a prescription dental gel containing sodium fluoride that helps prevent and treat tooth decay. It is applied directly to the teeth by a dental professional.

Is Gelato Neutral pH a controlled substance?

Gelato Neutral pH is not classified as a controlled substance by the DEA.

What is the generic name for Gelato Neutral pH?

The generic name for Gelato Neutral pH is Sodium Fluoride. There are 12 other brand versions of Sodium Fluoride.

What is the NDC code for Gelato Neutral pH 4.086 g/454g?

The NDC (National Drug Code) for Gelato Neutral pH 4.086 g/454g is 68400-114, listed by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc..