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#
Contacts and useful links#
Label contents#
Full prescribing information#
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
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
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Laboratory Instructions
- 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
- 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
| Construct and dry the stone model, cutting palate and tongue areas out. | |
| Vacuum adapt Sof-Tray® .035˝ sheet to model. Cool and separate. | |
| For 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
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EN- PATIENT INSTRUCTIONS
| Load gel into your bleaching tray made by your dentist. Use 1/3 to 1/2 of syringe. | |
| Brush teeth, then insert tray. Adapt tray sides to teeth. | |
| Remove excess gel with clean finger or soft toothbrush. Rinse twice; do not swallow rinses. | |
| Clean tray with soft brush and cool tap water. Store tray in case provided. |
SPL UNCLASSIFIED SECTION
| Use by date | |||
| See instructions | |||
| Recycle | |||
| Lot Number | |||
| Keep out of reach of children | |||
| Store at room temperature | |||
| Health Hazard | 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 For product SDS please see our website: 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
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Sodium Fluoride | ACTIVE INGREDIENT | 8ZYQ1474W7 | 3 | |
| Fluoride Ion | ACTIVE MOIETY | Q80VPU408O | 3 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| Polyethylene Glycol 300 | INACTIVE INGREDIENT | 5655G9Y8AQ | 3 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Products#
Every source-derived product name is available through these pages.
- Flor-Opal Sustained-Release Fluoride
- Sodium Fluoride
- Fluoride Ion
- Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)
- Glycerin
- Polyethylene Glycol 300
- Sodium Hydroxide
- Water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51206-401 | 51206-401-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Sodium Fluoride | 8ZYQ1474W7 | ACTIM |
| Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) | HHT01ZNK31 | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Polyethylene Glycol 300 | 5655G9Y8AQ | IACT |
| Sodium Hydroxide | 55X04QC32I | IACT |
| Water | 059QF0KO0R | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / ENDOTRACHEAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SYRUP / ORAL | 71 mg/5ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 27 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / VAGINAL | 20 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM, AUGMENTED / TOPICAL | 6 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SPRAY / NASAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / RESPIRATORY (INHALATION) | 8 %w/v | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / AURICULAR (OTIC) | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 0.35 %w/v | ||
| Polyethylene Glycol 300 | POLYETHYLENE GLYCOL 300 | 5655G9Y8AQ | INJECTION / INTRAMUSCULAR | 16950 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTABLE, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRATHECAL | 176 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / SOFT TISSUE | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | ELIXIR / ORAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / ORAL | 9120 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETHRAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRATUMOR | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | TABLET, DELAYED RELEASE / ORAL | 4 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / PARENTERAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / TRANSDERMAL | 472 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM / VAGINAL | 0.19 %w/w | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL, METERED / TRANSDERMAL | 350 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRALESIONAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 7.01 mg | ||
| Polyethylene Glycol 300 | POLYETHYLENE GLYCOL 300 | 5655G9Y8AQ | LIQUID / INTRAVENOUS | 5850 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / AURICULAR (OTIC) | 0.8 %w/w | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRACAUDAL | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | MOUTHWASH / BUCCAL | 2 mg/1ml | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / OPHTHALMIC | 6 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / DENTAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVENOUS | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | OINTMENT, AUGMENTED / TOPICAL | 0.11 %w/w | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETERAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / ORAL | 2 mg/5ml | ||
| Polyethylene Glycol 300 | POLYETHYLENE GLYCOL 300 | 5655G9Y8AQ | OINTMENT / TOPICAL | 1114 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CREAM / TOPICAL | 69 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / SUBARACHNOID | ADJ PH |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 97a027ea-85de-41af-b02d-8f50907cf455 | 728940aa-b994-4ca5-a30c-3957f22cf0fc | 2021-04-02 | 97a027ea-85de-41af-b02d-8f50907cf455 728940aa-b994-4ca5-a30c-3957f22cf0fc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.



















