Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second: Package Insert and Label Information

DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND- sodium fluoride gel
AMD Medicom Inc.

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.

General Information

AMD Medicom Inc.

DentiCare Pro-Gel

2.72% Topical Sodium Fluoride Gel

60 Second Application (1.23% fluoride ions)

Strawberry

16.23 fl oz / 480mL

NDC 64778-0219-1

NPN 80008336

RX Only in US

Item code 10021-ST

Indications and Directions

Indications: A topical anti-caries 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

Carboxy methyl cellulose sodium, phosphoric acid, water, saccharin sodium, titanium dioxide, red dye, strawberry flavor.

Warnings

KEEP OUT OF REACH OF CHILDREN. For professional use only. Not recommended for 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

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DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0219
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.0272 g in 1 mL
Product Characteristics
Color pink Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64778-0219-3 12 BOTTLE, PLASTIC in 1 CASE contains a BOTTLE, PLASTIC (64778-0219-1)
1 NDC:64778-0219-1 480 mL in 1 BOTTLE, PLASTIC This package is contained within the CASE (64778-0219-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/2005
Labeler — AMD Medicom Inc. (256880576)
Registrant — AMD Medicom Inc. (256880576)

Revised: 01/2021 AMD Medicom Inc.

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