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Denti-Care Denti-Pro

AR Medicom Inc

Denti-Care Denti-Pro 60 Sec Gel 2.72 % Topical Sodium Fluoride Gel Raspberry




FULL PRESCRIBING INFORMATION

Medicom

Denti-Care

Denti-Pro 60 Sec Gel

2.72 % Topical Sodium Fluoride Gel

60 Second Application (1.23 % fluoride ions)

Raspberry

16.23 fl oz / 480mL

NDC 64778-0218-1

NPN 80008336

Item code 10021-RB

Denti-Care Denti-Pro




A topical anti-caries preparation. Optimized low pH for penetration. Ideal thixotropic action. Artificially flavoured.

Directions:

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)

Non-Medicinal ingredients: hydroxyethyl cellulose, phosphoric acid, purified water, red 33, blue 1, saccharin sodium (anhydrous), titanium dioxide, raspberry flavour.

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.

Made in USA for AR Medicom Inc., Montreal, Canada, H8T 3J8

Questions 1-800-361-2862 or www.medicom.com

UPC 686864018674

No. 112447

Denti-Care Denti-Pro

Sodium Fluoride GEL

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:64778-0218
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION .0272 g

Product Characteristics

Color
pink

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64778-0218-1 480 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2005-04-01


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