Darby Topical Fluoride Foam

Generic Name: sodium fluoride
Dosage Form: aerosol, foam

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.

DARBY 2.72 % Topical Sodium Fluoride Foam Mint

Darby 2.72 % Topical Sodium Fluoride Foam

(1.23 % Fluoride Ions)

Mint

4.4 oz / 125 g

NDC 66467-3760-1




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)



Non-Medicinal ingredients: cocamidopropyl betaine, sodium phosphate, poloxamer 407, sucralose, xylitol, purified water, mint flavour

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
Made in USA
Distributed by:
Darby Dental Supply, LLC
Jericho, Ny11753
UPC 952-9102
Rev 01

DARBY   TOPICAL SODIUM FLUORIDE MINT
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66467-3760
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sodium fluoride (fluoride ion) fluoride ion .0272 g  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor MINT Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:66467-3760-1 125 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
Labeler - Darby Dental Supply Co (825137818)
Revised: 11/2011
 
Darby Dental Supply Co



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