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Darby

Darby Dental Supply Co

DARBY 2.72 % Topical Sodium Fluoride Foam Mint




FULL PRESCRIBING INFORMATION

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:



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.






Darby

Darby

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 .0272 g

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66467-3760-1 125 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-01-31


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