Label: DARBY TOPICAL SODIUM FLUORIDE STRAWBERRY- sodium fluoride aerosol, foam
- Label RSS
- Share
- NDC Code(s): 66467-3790-1
- Packager: Darby Dental Supply Co
- 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.
Drug Label Information
Updated November 22, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DESCRIPTION
Darby 2.72 % Topical Sodium Fluoride Foam
(1.23 % Fluoride Ions)
Strawberry
4.4 oz / 125 g
NDC 66467-3790-1
Close
- DOSAGE & ADMINISTRATION
A topical anti-caries preparation
Directions (for professional use only):
1. Use after thorough prophylaxis
2. To dispense, shake bottle vigorously then invert applicator 180 degrees downward to the bottom of the tray(s)
Note: fill tray(s) at one quarter full to allow foam to expand
3. Insert tray(s) in mouth and have patient bite down lightly for 1 minute or up to 4 minutes
4. Remove tray(s) and have patient expectorate excess
5. Advise patient not to eat, drink or rinse for 30 minutes after the application
130 applications
Medicinal ingredients:
Fluoride ions 1.23 % w/w (from 2.72 % w/w sodium fluoride)
Close
- INACTIVE INGREDIENT
Non-Medicinal ingredients: cocamidopropyl betaine, sodium phosphate, poloxamer 407, sucralose, xylitol, purified water, strawberry flavour Close
- WARNINGS AND PRECAUTIONS
Warnings: KEEP OUT OF REACH OF CHILDREN
Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F. Contents under pressure. Do not puncture and incinerate.
Do not use if seal is broken.
Rx only Close
- SPL UNCLASSIFIED SECTION
- INGREDIENTS AND APPEARANCE
DARBY TOPICAL SODIUM FLUORIDE STRAWBERRY
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-3790 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 g Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66467-3790-1 125 g in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/31/2012 CloseLabeler - Darby Dental Supply Co (825137818)
