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Denti-Care

AR Medicom Inc

Denti-Care Denti-Foam Topical Fluoride Foam grape 1.23% Fluoride Ions




FULL PRESCRIBING INFORMATION

Denti-Care

Denti-Foam

Topical Fluoride Foam Grape

1.23 % Fluoride Ions

4.4 oz / 125 g

NDC 64778-1375-1




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.








Denti-Care

Denti-Care

Fluoride Ions AEROSOL, FOAM

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:64778-1375
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION .0176 g
Hydrofluoric Acid Hydrofluoric Acid 0.010 g

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64778-1375-1 125 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2003-05-01


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