Label: DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND- sodium fluoride gel
- NDC Code(s): 64778-0214-2
- Packager: AR Medicom Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated February 22, 2010
If you are a consumer or patient please visit this version.
Denti-Pro 60 Sec Gel
2.72 % Topical Sodium Fluoride Gel
60 Second Application (1.23 % fluoride ions)
16.23 fl oz / 480mL
Item code 10021-CHClose
- DOSAGE & ADMINISTRATION
A topical anti-caries preparation. Optimized low pH for penetration. Ideal thixotropic action. Artificially flavoured.
1. Use after thorough prophylaxis
2. To dispense, fill tray(s) 1/3 with gel
3. Insert tray(s) in mouth and have patient bite down lightly for 60 seconds
4. Remove tray(s) and have patient expectorate excess
5. Advise patient not to eat, drink or rinse for 30 minutes after the application
Medicinal ingredients: Fluoride ions 1.23 % w/w (from 2.72 % w/w sodium fluoride)Close
- INACTIVE INGREDIENT
Non-Medicinal ingredients: hydroxyethyl cellulose, phosphoric acid, purified water, red 33, saccharin sodium (anhydrous), titanium dioxide, cherry flavourClose
- WARNINGS AND PRECAUTIONS
Warnings: KEEP OUT OF REACH OF CHILDREN. For professional use only. Do not swallow.
Not recommended for children under 18 months of age.
Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F.
Do not use if seal is broken.Close
- SPL UNCLASSIFIED SECTION
Made in USA for AR Medicom Inc., Montreal, Canada, H8T 3J8
Questions 1-800-361-2862 or www.medicom.com
No. 112443Rev.2 Close
- INGREDIENTS AND APPEARANCE
DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND
sodium fluoride gel
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0214 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) fluoride ion .0272 g in 1 mL Product Characteristics Color pink Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64778-0214-2 480 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/01/1999 Labeler - AR Medicom Inc (247876295)