DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND- sodium fluoride gel

Denti-Care Denti-Pro by

Drug Labeling and Warnings

Denti-Care Denti-Pro by is a Prescription medication manufactured, distributed, or labeled by AMD Medicom Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

General Information

AMD Medicom Inc.

DentiCare Pro-Gel

2.72% Topical Sodium Fluoride Gel

60 Second Application (1.23% fluoride ions)

Grape

16.23 fl oz / 480mL

NDC: 64778-0215-1

NPN 80008336

RX Only in US

Item code 10021-GR

Indication and Directions

Indications: Topical anti-carie preparation

Directions:

1. Following prophylaxis treatment, Fill 1/3 of tray with gel
2. Insert tray in the patient’s mouth
3. Have patient bite down lightly for 60 seconds
4. Remove tray and have patient expectorate excess

Advise patient not to eat, drink or rinse for 30 minutes after application.

Medicinal ingredients: Fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)

Non-Medicinal Ingredients

Carboxymethyl cellulose sodium, phosphoric acid, water, saccharin sodium, titanium dioxide, red dye, blue dye, grape flavor

Warnings

KEEP OUT OF REACH OF CHILDREN. For professional use only. Not recommended for use by children under 18 months of age.

Store at room temperature. Do not expose to excessive heat over 40°C or 104°F.

Do not use if seal is broken.

Contact Information

Made in USA for AMD Medicom Inc.
2555 Chemin de l’Aviation,
Pointe-Claire, Quebec, Canada
H9P 2Z2

Questions: 1-800-361-2862

www.medicom.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

DENTI-CARE DENTI-PRO  TOPICAL SODIUM FLUORIDE 60 SECOND
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64778-0215
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0272 g  in 1 mL

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64778-0215-3	12 in 1 CASE	12/01/2017
1	NDC: 64778-0215-1	480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/1999

Labeler - AMD Medicom Inc. (256880576)

Registrant - AMD Medicom Inc. (256880576)