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Name:Denti-care Denti-foamtopical Sodium Fluoride Bubble Gum
Manufacturer:Ar Medicom Inc
Category:Prescription Marketed Drugs


Denti-Care Denti-Foam 2.72 % Topical Sodium Fluoride Foam Bubble Gum

DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE BUBBLE GUM - sodium fluoride aerosol, foam 
AR 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.

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Denti-Care Denti-Foam 2.72 % Topical Sodium Fluoride Foam Bubble Gum

Medicom

Denti-Care

Denti-Foam

2.72 % Topical Sodium Fluoride Foam (1.23 % Fluoride Ions)

Bubblegum

4.4 oz / 125 g

NDC 64778-0373-1

NPN 80009738

10037Bubblegum




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:

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



Non-Medicinal ingredients: cocamidopropyl betaine, phosphoric acid, poloxamer 407, sucralose, tartaric acid, xylitol, purified water, bubblegum flavour

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.

Rx (in US only)

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

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

UPC 686864008668

No. 112479

Item Code 10037-BG

Rev 2

DENTI-CARE DENTI-FOAM  TOPICAL SODIUM FLUORIDE BUBBLE GUM
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0373
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sodium fluoride (fluoride ion) fluoride ion .0272 g  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64778-0373-1 125 g in 1 BOTTLE, SPRAY None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/01/2003

Labeler - AR Medicom Inc (247876295)

Revised: 02/2010 AR Medicom Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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