DENTI-CARE TOPICAL FLUORIDE FOAM BUBBLE GUM- fluoride ions 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 Topical Fluoride Foam Bubble Gum 1.23% Fluoride Ions

Denti-Care

Denti-Foam

Topical Fluoride Foam Bubble Gum

1.23 % Fluoride Ions

4.4 oz / 125 g

NDC 64778-1373-1




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, bubble gum 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 686864008668
Item code 10037-BG
Rev 00

10037foambg
DENTI-CARE  TOPICAL FLUORIDE FOAM BUBBLE GUM
fluoride ions aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-1373
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) sodium fluoride.0176 g  in 1 g
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) HYDROFLUORIC ACID0.010 g  in 1 g
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-1373-1125 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/09/2011
Labeler - AR Medicom Inc (247876295)

Revised: 2/2011
Document Id: a24a83eb-3f91-496a-b78a-95b5a0b3db76
Set id: 8f73af62-6124-4bf6-915d-4b913add7ad1
Version: 1
Effective Time: 20110209
 
AR Medicom Inc