Flor-Opal ® Sustained Released Fluoride Gel

Manufacturer
Ultradent Products, Inc
Effective date
2021-04-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:47:50

Label at a glance#

ProductFlor-Opal Sustained-Release Fluoride
Active ingredientSodium Fluoride
Label structure7 sections

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

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

INDICATIONS & USAGE SECTION

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).

Procedure

DOSAGE & ADMINISTRATION SECTION

  • Read and understand instructions before using or dispensing to patients.
  • 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:Attn:
  • 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.
  • 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.
  • 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.
  • Gel may be warmed before placing in tray to avoid thermal sensitivity.
Fig. 1Fig. 1Fig. 2Fig. 2

Laboratory Instructions

DOSAGE & ADMINISTRATION SECTION

  • 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.
  • 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.
  • 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.
  • Cut excess bulk of material away with Ultra-Trim™ scalloping scissors.
  • Trim excess tray material. Contour the tray margin to avoid frenum attachments, tori, and similar anatomical structures.
  • Return tray to model; check tray extensions. Gently flame polish edges one quadrant at a time (Blazer® Micro Torch).
  • 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

PRECAUTIONS SECTION

  • If any problems occur, have the patient discontinue treatment and notify the dentist.
  • 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.
  • Keep out of heat and sunlight at all times. Flor-Opal should be stored at room temperature.
  • Not intended for use by pregnant women.

EN- DENTIST INSTRUCTIONS & LAB INSTRUCTIONS

SPL UNCLASSIFIED SECTION

Figure 3Figure 3Construct and dry the stone model, cutting palate and tongue areas out.
Figure 4Figure 4Vacuum adapt Sof-Tray® .035˝ sheet to model. Cool and separate.
Figure 5Figure 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

GENERAL PRECAUTIONS SECTION

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

EN- PATIENT INSTRUCTIONS

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Use by dateUse by date

Use by date

See instructionsSee instructions

See instructions

RecycleRecycle

Recycle

Batch CodeBatch Code

Lot Number

Keep out of reach of childrenKeep out of reach of children

Keep out of reach of children

Recommended Storage TemperatureRecommended Storage Temperature

Store at room temperature

ToxicToxic

Health Hazard

For Professional use only.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
FigureFigure
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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 1.2 ml Syringe Package

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W73
Fluoride IonACTIVE MOIETYQ80VPU408O3
GlycerinINACTIVE INGREDIENTPDC6A3C0OX3
Polyethylene Glycol 300INACTIVE INGREDIENT5655G9Y8AQ3
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I3
WaterINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51206-40151206-401-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 262 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISYRUP / ORAL71 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR27 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / VAGINAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICREAM, AUGMENTED / TOPICAL6 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISPRAY / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / RESPIRATORY (INHALATION)8 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR0.35 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
Polyethylene Glycol 300POLYETHYLENE GLYCOL 3005655G9Y8AQINJECTION / INTRAMUSCULAR16950 mgExact identifier — unii candidate
13 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTABLE, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRATHECAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IELIXIR / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / ORAL9120 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / URETHRALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATUMORADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ITABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / TRANSDERMAL472 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICREAM / VAGINAL0.19 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL, METERED / TRANSDERMAL350 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR7.01 mgExact identifier — unii candidate
174 equally ranked IID candidates
Polyethylene Glycol 300POLYETHYLENE GLYCOL 3005655G9Y8AQLIQUID / INTRAVENOUS5850 mgExact identifier — unii candidate
13 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
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Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / AURICULAR (OTIC)0.8 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IMOUTHWASH / BUCCAL2 mg/1mlExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / OPHTHALMIC6 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IOINTMENT, AUGMENTED / TOPICAL0.11 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / URETERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
Polyethylene Glycol 300POLYETHYLENE GLYCOL 3005655G9Y8AQOINTMENT / TOPICAL1114 mgExact identifier — unii candidate
13 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBARACHNOIDADJ PHExact identifier — unii candidate
174 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
97a027ea-85de-41af-b02d-8f50907cf455728940aa-b994-4ca5-a30c-3957f22cf0fc2021-04-02Exact identifier
spl id: 97a027ea-85de-41af-b02d-8f50907cf455
spl set id: 728940aa-b994-4ca5-a30c-3957f22cf0fc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.