Flor-opal Sustained-release Fluoride
Sodium Fluoride
Ultradent Products, Inc
Human Prescription Drug
NDC 51206-401Flor-opal Sustained-release Fluoride also known as Sodium Fluoride is a human prescription drug labeled by 'Ultradent Products, Inc'. National Drug Code (NDC) number for Flor-opal Sustained-release Fluoride is 51206-401. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Flor-opal Sustained-release Fluoride drug includes Sodium Fluoride - 5 mg/mL . The currest status of Flor-opal Sustained-release Fluoride drug is Active.
Drug Information:
| Drug NDC: | 51206-401 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Flor-opal Sustained-release Fluoride |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sodium Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Ultradent Products, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SODIUM FLUORIDE - 5 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | DENTAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 31 May, 1990 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Jan, 2024 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 14 Jun, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Ultradent Products, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 8ZYQ1474W7
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51206-401-01 | 20 SYRINGE, PLASTIC in 1 PACKAGE (51206-401-01) / 1.2 mL in 1 SYRINGE, PLASTIC | 31 May, 1990 | 31 Jan, 2024 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Flor-opal sustained-release fluoride sodium fluoride sodium fluoride fluoride ion carbomer homopolymer type b (allyl pentaerythritol crosslinked) glycerin polyethylene glycol 300 sodium hydroxide water
Indications and Usage:
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).
General Precautions:
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.
Dosage and Administration:
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. 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 n
Read more...ight 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. fig. 1 fig. 2 attn: figure 1 figure 2
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 (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 econoformâ¢), 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
Read more... (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.
Description:
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.
Package Label Principal Display Panel:
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