CND Duraflor Tube Insert FRE

www.medicom.com
DATE: April 9th, 2010
PRODUCT INSERT and INSTRUCTIONS FOR USE
For Professional Use Only
PROPERTIES: Duraflor® and Duraflor® Halo is a clinically-tested sodium fluoride-containing varnish
that has a particularly time-saving application. Duraflor® and Duraflor® Halo is remarkably
water-tolerant and therefore covers even moist teeth with a well-adhering film of varnish which
hardens upon contact with moisture or saliva and remains on tooth surfaces for several hours.
DATE
24/JAN/05
08/NOV/06
09/APR/10
INI
Created Artwork.
No notes on file.
Updated artwork to match Canadian look.
NOTES
GRAPHIC DESIGNER
QA / RA
JS
TBB
JM
DATE
DATE
DATE
A.R Medicom Inc. 1200 55th Avenue Lachine, Quebec H8T 3J8 Tel: 514-636-6262
Contact: James Melo
email: jmelo@medicom.ca
REVISION
00
01
02
MARKETING
PRODUCT DEVELOPMENT MANAGER
BRAND MANAGER / PRODUCT MANAGER
INDICATIONS: Duraflor® and Duraflor® Halo are indicated for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity. They are fluoride applications that can also
be used to seal dentinal tubules for cavity preparation.
CONTRAINDICATIONS: Ulcerative gingivitis and stomatitis. Known allergies or reactions to
colophony (colophonium) or similar agents. Avoid ingestion during application. Not to be used as a
systemic treatment.
ADVERSE REACTIONS: Edematous swelling has been reported only in rare instances, especially
after application to extensive surfaces. Dyspnea, although extremely rare, has occurred in asthmatic
people. Nausea has been reported when extensive applications have been made to patients with
sensitive stomachs. If required, varnish is easily removed with thorough tooth brushing and rinsing.
APPLICATION: For cavity preparation: 0.1 mL.
For use on hypersensitive teeth: 0.25 mL for pediatric use and single use application.
All other fluoride preparations such as gels and foams should not be administered on the same day
as the Duraflor® application. Daily application of fluoride should be stopped for several days after the
treatment.
Two applications at several days interval are sufficient in most cases. The fluoride content is dosed in
such a way that neither acute nor chronic side effects are to be expected if applied accordingly by
following the instructions.
STEP I - TO OPEN PACKAGING
TUBE – Use the cap to push open the seal of the tube. It is recommended to use a disposable brush
to apply.
UNIT (CUP) - Peel open the foil lidding material starting from the unsealed tab exposing the brush
and varnish. If needed, the varnish cup can be broken off and inserted into the included metal prophy
paste finger ring. Remove brush and mix varnish until it reaches an even consistency. Dispose after
use; do not re-use brush applicator. All non disposable instruments in contact with product should be
cleansed with alcohol.
STEP II A - DIRECTION OF USE
AS A FLUORIDE APPLICATION FOR HYPERSENSITIVITY
1. For best results, dry teeth prior to application by rubbing a SafeGauze® Sponge along the tooth
surfaces to remove any existing bio-film.
2. Apply a very thin coat of Duraflor® or Duraflor® Halo varnish evenly to all of the desired tooth
surfaces.
3. Let the varnish dry for approximately 10 seconds and then instruct the patient to close their mouth.
4. Varnish hardens on contact with saliva so the patient may leave immediately after application.
5. When dry, any excess varnish may appear "spotty" and may slide off the tooth surface. This will
not affect the efficacy of the product as there is still a full layer of varnish on the tooth.
6. It is recommended that the patient be instructed to only eat soft foods and drink cold liquids for
two hours after the application.
7. Duraflor® and Duraflor® Halo can be removed with thorough brushing and rinsing.
STEP II B - DIRECTION OF USE
AS A CAVITY LINER:
1. Clean and dry cavity preparation.
2. Apply Duraflor® or Duraflor® Halo in conventional manner.
3. Gently thin the excessive varnish out of the cavity until the varnish surface is dry.
4. Apply a second coat of varnish in the same manner.
5. Proceed with restoration.
6. It is recommended that the patient be instructed to only eat soft foods and drink cold liquids for
two hours after the application.
7. Duraflor® and Duraflor® Halo can be removed with thorough brushing and rinsing.
NON MEDICINAL INGREDIENTS
Duraflor®: Denatured alcohol, rosin, xylitol, yellow beeswax, sucralose, flavor.
Duraflor® Halo: Denatured alcohol, rosin, xylitol, white beeswax, sucralose, titanium dioxide, flavor.
Duraflor Product
Item #
Supply (available in)
Flavors
Tube
10011-US
10 mL tube
Bubble Gum
Unit (32)
1011-BG32
Kits of 32 units x 0.25 mL
Bubble Gum
Unit (32)
1011-RB32
Kits of 32 units x 0.4 mL
Raspberry
Unit (200)
1011-BG200
Kits of 200 units x 0.25 mL
Bubble Gum
Unit (200)
1011-RB200
Kits of 200 units x 0.4 mL
Raspberry
Halo (32)
1015-SM32
Kits of 32 units x 0.5 mL
Spearmint
Halo (32)
1015-WB32
Kits of 32 units x 0.5 mL
Wild Berry
Halo (250)
1015-SM250
Kits of 250 units x 0.5 mL
Spearmint
Halo (250)
1015-WB250
Kits of 250 units x 0.5 mL
Wild Berry
DATE
DATE
Do not use if seal is broken.
STORE BETWEEN 59°F - 86°F (15°C – 30°C)
Manufactured for:
A.R. Medicom Inc. Montreal, QC, Canada H8T 3J8
REV02
FILE NAME: USA Duraflor Tube Insert.ai
FILE DESCRIPTION: USA Duraflor Tube Insert
COLOUR INFORMATION
K
DURAFLOR and DURAFLOR HALO
5% Sodium Fluoride Varnish
1 mL = 50 mg Sodium Fluoride
112945