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Denti-Care Denti-Foam Topical Sodium Fluoride Foam

Generic Name: fluoride ions
Dosage Form: aerosol, foam

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.

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

Denti-Care

Denti-Foam

Topical Fluoride Foam Orange

1.23 % Fluoride Ions

4.4 oz / 125 g

NDC 64778-1377-1




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:

Fluoride ions 1.23 % w/w (from 1.76 % sodium fluoride and 1.04% hydrofluoric acid)



Non-Medicinal ingredients: sodium saccharin, sodium benzoate, plasdone C30, glycerin USP, propylene glycol, polysorbate 20, stepanol WA 100, phosphoric acid, purified water, orange flavor

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 Only
Manufactured in Canada for
AR Medicom Inc
Montreal, Canada, H8T 3J8
Questions 1-800-361-2862 or www.medicom.com
UPC 686864008651
Item code 10037-O
Rev 00

DENTI-CARE  TOPICAL FLUORIDE FOAM ORANGE
fluoride ions aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64778-1377
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sodium fluoride (FLUORIDE ION) sodium fluoride .0176 g  in 1 g
HYDROFLUORIC ACID (FLUORIDE ION) HYDROFLUORIC ACID 0.010 g  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor ORANGE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:64778-1377-1 125 g in 1 BOTTLE, SPRAY
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: 02/2011
 
AR Medicom Inc



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