Label: FLOR-OPAL SUSTAINED-RELEASE FLUORIDE- sodium fluoride gel

  • NDC Code(s): 51206-401-01, 51206-402-01
  • Packager: Ultradent Products, Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 12/12

If you are a consumer or patient please visit this version.

  • 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.

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  • 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).

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  • Procedure

    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

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  • Laboratory Instructions

    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 (Ultra-Lume ®) can be used (approximately 20-40 seconds per tooth). 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 watermoistened 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.
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  • 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 3 Construct and dry the stone model, cutting palate and tongue areas out.
    Figure 4 Vacuum adapt Sof-Tray® .035˝ sheet to model. Cool and separate.
    Figure 5 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

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

    Legend:

    Use by date

    Use by date

    See instructions

    See instructions

    Batch Code

    Batch Code

    Keep out of reach of children

    Keep out of reach of children

    Recommended Storage Temperature

    Recommended Storage Temperature

    Toxic

    EN Toxic

    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 MSDS, please visit our website:
    www.ultradent.com
    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 2011 Ultradent Products, Inc. All Rights Reserved.

    ULTRADENT
    PRODUCTS, INC.

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

    #10115.4    021011

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  • PRINCIPAL DISPLAY PANEL - 1.2ml Syringe Label

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

    #22505.2
    042208

    T

    PRINCIPAL DISPLAY PANEL - 1.2ml Syringe Label
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  • PRINCIPAL DISPLAY PANEL - 10 Tray Box Label

    Flor-Opal®
    sustained released fluoride gel

    REF/UP 5725

    10 - Upper Trays

    10 - Lower Trays

    Store at Room
    Temperature

    U.S. Patent Nos. 5,575,654; 5,863,202; 5,980,249; 7,040,897; 7,056,118 ; 7,059,857; 7,059,858; 7,568,579; 7,625,210 ; AU Patent No.
    2004243104. Other U.S. and International Patents Pending.

    Made in U.S.A.

    45663.6
    040611

    PRINCIPAL DISPLAY PANEL - 10 Tray Box Label
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  • INGREDIENTS AND APPEARANCE
    FLOR-OPAL SUSTAINED-RELEASE FLUORIDE 
    sodium fluoride gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51206-401
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Fluoride Ion 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin  
    Polyethylene Glycol 300  
    Sodium Hydroxide  
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51206-401-01 20 in 1 PACKAGE
    1 1.2 mL in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 05/31/1990
    FLOR-OPAL SUSTAINED-RELEASE FLUORIDE 
    sodium fluoride gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51206-402
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Fluoride Ion 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Carboxymethylcellulose  
    Glycerin  
    Polyethylene Glycols  
    Silicon Dioxide  
    Sodium Benzoate  
    Sodium Hydroxide  
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51206-402-01 10 in 1 BOX
    1 1.87 mL in 1 TRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 03/01/2005
    Labeler - Ultradent Products, Inc (013369916)
    Establishment
    Name Address ID/FEI Business Operations
    Ultradent Products, Inc 013369916 MANUFACTURE(51206-401, 51206-402)
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