Label: DARBY TOPICAL SODIUM FLUORIDE- sodium fluoride gel
- NDC Code(s): 66467-2190-1
- Packager: Darby Dental Supply, LLC
- 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 March 30, 2017
If you are a consumer or patient please visit this version.
Darby 60 Sec Fluoride Gel
2.72 % Topical Sodium Fluoride Gel
60 Second Application (1.23 % fluoride ions)
16.23 fl oz / 480mL
- DOSAGE & ADMINISTRATION
A topical anti-caries preparation. Optimized low pH for penetration. Ideal thixotropic action. Artificially flavored.
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
- WARNINGS AND PRECAUTIONS
Warnings: KEEP OUT OF REACH OF CHILDREN. For professional use only. Do not swallow.
Not recommended for use by 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
Darby Dental Supply, LLC
Jericho, NY 11753
- INGREDIENTS AND APPEARANCE
DARBY TOPICAL SODIUM FLUORIDE
sodium fluoride gel
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-2190 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.0272 g in 1 mL Product Characteristics Color pink Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66467-2190-1 480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/12/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/12/2010 Labeler - Darby Dental Supply, LLC (825137818)