Gelato Neutral PH
Generic Name: sodium fluoride
Dosage Form: dental gel
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.
Sodium Fluoride 2%
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.
- 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.
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.
- Store at controlled room temperature 59° to 86°F (15° to 30°C).
- Protect from freezing.
Citric Acid, FD&C Red #40, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol
|Gelato Neutral PH
sodium fluoride gel
|Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (078654194)|
|Registrant - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)|
|Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.||078654194||manufacture(68400-115), label(68400-115)|