Skip to main content

Flor-Opal Gel: Package Insert / Prescribing Info

Package insert / product label
Generic name: sodium fluoride
Dosage form: sustained released gel
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Mar 29, 2024.

Flor-Opal Gel Description

Flor-Opal® is a unique, sustained-release, 0.5% fluoride ion in a sticky, viscous gel to be used with a custom tray. Flor-Opal is a clear, nearly tasteless, high-viscosity sticky gel with a pH of ~6.5.

Indications and Usage for Flor-Opal Gel

Flor-Opal is designed for use whenever topical fluoride application is desired via take-home tray (e.g., prevention of root caries, treatment of periodontal conditions, following bleaching procedures, root sensitivity).

Flor-Opal Gel Dosage and Administration

1.
Read and understand instructions before using or dispensing to patients.
2.
Fabricate tray to meet patient's needs. See laboratory instructions (page 2) or send the working cast/model and prescription order form to Ultradent. Areas of sensitivity should be indicated on the cast before sending the model. If patient already has a custom bleaching tray, instruct them to apply Flor-Opal in the same manner as the bleaching gel.
Note: Trays made only for Flor-Opal may be constructed without scalloping; however, one should scallop trays made for Opalescence® bleaching.
Attn:
3.
Flor-Opal is dispensed in 1.2ml unit dose syringes. An application of a complete arch should use most of the contents of one unit dose syringe. Tray is loaded by running gel on underside of occlusal and incisal areas.
4.
The length and number of times the tray is worn depends on the condition, the patient, and the clinician. Recommended treatment times generally range from 2 to 8 hours. Wearing the tray at night may be suggested since the gel generally stays active in the tray 8-10 hours because of slower muscle and salivary activity at night. Gel usually lasts 4-6 hours with daytime activity.
5.
Tray should be removed at meal times. Following tray removal, patient should brush and rinse with water. DO NOT swallow solution during rinsing. Wash tray and store in a tray storage case. Fresh gel should be used for each application.
6.
Gel may be warmed before placing in tray to avoid thermal sensitivity.
Figure 1

Fig. 1

Figure 2

Fig. 2

Flor-Opal Gel Dosage and Administration

1.
Pour and trim cast as you would for a standard bleaching tray. Apply 0.5-1.0mm of Ultradent® LC Block-Out Resin to a clean, dry cast.
2.
Cure LC Block-Out for ~2 minutes in a light curing unit. A hand-held intraoral light (VALO® or another high quality curing light (output > 600mw/cm2)) can be used. Light cure 20 seconds using a scanning motion over the arch. Carefully check resin cure by tapping the surface of the resin with an instrument. Wipe off oxygen inhibition layer.
3.
With vacuum former (Ultra-Form® or EconoForm™), heat a Sof-Tray® sheet until it sags ~1 inch. Activate vacuum and adapt softened plastic over mold. Cool and remove model.
4.
Cut excess bulk of material away with Ultra-Trim™ scalloping scissors.
5.
Trim excess tray material. Contour the tray margin to avoid frenum attachments, tori, and similar anatomical structures.
6.
Return tray to model; check tray extensions. Gently flame polish edges one quadrant at a time (Blazer® Micro Torch).
7.
While still warm, hold periphery of each segment firmly against model for 3 seconds with water-moistened finger. If an area is short of the desired length, gently heat and push the tray material to the desired location. If this material thins too much, a new tray should be fabricated.

Precautions

1.
If any problems occur, have the patient discontinue treatment and notify the dentist.
2.
Patients should not swallow large volumes of Flor-Opal gel. Excess at insertion and residue upon removal should be brushed off and rinsed; DO NOT swallow.
3.
Keep out of heat and sunlight at all times. Flor-Opal should be stored at room temperature.
4.
Not intended for use by pregnant women.

EN- DENTIST INSTRUCTIONS & LAB INSTRUCTIONS

Figure 3Construct and dry the stone model, cutting palate and tongue areas out.
Figure 4Vacuum adapt Sof-Tray® .035˝ sheet to model. Cool and separate.
Figure 5For sensitive roots use Ultradent's LC Block-Out Resin on gingival margin to provide a reservoir space for Flor-Opal. It is recommended to lap tray 2-3mm onto gingiva.

General Precautions

1.
For professional use only.
2.
Review instructions, precautions, and MSDS before beginning treatment. Use only as directed.
3.
Keep products out of heat/sunlight.
4.
Avoid skin exposure to resins.
5.
Isolate strong chemicals to area of treatment.
6.
Confirm that patient has no known allergies to treatment materials.
7.
Test flow of materials from syringe and tip before using intraorally.
8.
Never force syringe plungers.
9.
Clean and disinfect syringes between patients.

EN- PATIENT INSTRUCTIONS

Figure 6Load gel into your bleaching tray made by your dentist. Use 1/3 to 1/2 of syringe.
Figure 7Brush teeth, then insert tray. Adapt tray sides to teeth.
Figure 8Remove excess gel with clean finger or soft toothbrush. Rinse twice; do not swallow rinses.
Figure 9Clean tray with soft brush and cool tap water. Store tray in case provided.

Use by date

Use by date

See instructions

See instructions

Recycle

Recycle

Batch Code

Lot Number

Keep out of reach of children

Keep out of reach of children

Recommended Storage Temperature

Store at room temperature

Toxic

Health Hazard

For Professional use only.

EN For Professional use only.

Not for injection.

Ultradent syringes have an expiration date stamped on the side of the syringe consisting of one letter and three numbers.
The letter is a lot number used for manufacturing purposes and the three numbers are the expiration date.
The first two numbers are the month, and the third number is the last number of the year.

Flor-Opal
Figure
For product SDS please see our
website: www.ultradent.com
1-800-552-5512; 801-572-4200		Hazard Rating

4 = Severe
3 = Serious
2 = Moderate
1 = Slight
0 = Minimal

For professional use only.
U.S. federal law restricts the sale of this device by or on the order of a dentist.
Keep out of reach of children.

For immediate reorder and/or complete descriptions of Ultradent's product line, refer to Ultradent's catalog or call Toll Free 1-800-552-5512.
Outside U.S. call (801) 572-4200
or visit www.ultradent.com.

© Copyright 2017 Ultradent Products, Inc. All Rights Reserved.

ULTRADENT
PRODUCTS, INC.

Manufatured by Ultradent Products, Inc.
505 West Ultradent Drive (10200 South)
South Jordan, Utah 84095, USA Made in USA

Ultradent Products GmbH
Am Westhover Berg 30
51149 Cologne Germany

10115.10 040517

PRINCIPAL DISPLAY PANEL - 1.2 ml Syringe Package

Flor-Opal®
REF/UP 224
• 20 - 1.2 ml Flor-Opal
Sustained Release Fluoride Gel/

22505.7
040517

PRINCIPAL DISPLAY PANEL - 1.2 ml Syringe Package
FLOR-OPAL SUSTAINED-RELEASE FLUORIDE
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51206-401
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion5 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31)
Glycerin (UNII: PDC6A3C0OX)
Polyethylene Glycol 300 (UNII: 5655G9Y8AQ)
Sodium Hydroxide (UNII: 55X04QC32I)
Water (UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51206-401-0120 in 1 PACKAGE05/31/199001/31/2024
11.2 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER05/31/199001/31/2024
Labeler - Ultradent Products, Inc (013369913)
Establishment
NameAddressID/FEIBusiness Operations
Ultradent Products, Inc013369913MANUFACTURE(51206-401) , LABEL(51206-401) , ANALYSIS(51206-401) , PACK(51206-401)

Medical Disclaimer