RxNorm Names
GELATO APF GEL CHERRY 16OZ
(apf gel)
gel
[Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c2d3d7f9-00cf-4d85-af51-71f150cd0289| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN PRESCRIPTION DRUG LABEL | unapproved drug other |
NOTE: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.
- A stable thixtropic 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 quantites 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.
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.
| GELATO APF GEL CHERRY 16OZ
apf gel gel |
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| 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) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 078654194 | manufacture(68400-106), label(68400-106) | |
Revised: 02/2013
Document Id: bca6633d-6f82-4d1b-a4ba-848b8b238945
Set id: c2d3d7f9-00cf-4d85-af51-71f150cd0289
Version: 3
Effective Time: 20130226
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
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