Topex Neutral Ph Fluoride Gel Strawberry
Sodium Fluoride
Dentsply Llc. Professional Division Trading As "sultan Healthcare"
Human Prescription Drug
NDC 0699-0702Topex Neutral Ph Fluoride Gel Strawberry also known as Sodium Fluoride is a human prescription drug labeled by 'Dentsply Llc. Professional Division Trading As "sultan Healthcare"'. National Drug Code (NDC) number for Topex Neutral Ph Fluoride Gel Strawberry is 0699-0702. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Topex Neutral Ph Fluoride Gel Strawberry drug includes Fluoride Ion - 9 mg/g . The currest status of Topex Neutral Ph Fluoride Gel Strawberry drug is Active.
Drug Information:
| Drug NDC: | 0699-0702 |
| 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: | Topex Neutral Ph Fluoride Gel Strawberry |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Topex Neutral Ph Fluoride Gel |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Strawberry |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Dentsply Llc. Professional Division Trading As "sultan Healthcare" |
| 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: | FLUORIDE ION - 9 mg/g
|
| 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: | 01 Jan, 1974 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2025 |
| 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: | 31 Dec, 2023 |
| 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: | Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 245593
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | Q80VPU408O
|
| 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 |
|---|
| 0699-0702-16 | 495 g in 1 BOTTLE (0699-0702-16) | 01 Jan, 1974 | N/A | 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:
Topex neutral ph fluoride gel strawberry sodium fluoride fluoride ion fluoride ion carbomer homopolymer type b (allyl pentaerythritol crosslinked) water saccharin sodium methylparaben benzoic acid sodium phosphate, dibasic, anhydrous xanthan gum sodium hydroxide topex neutral ph fluoride gel mint sodium fluoride fluoride ion fluoride ion carbomer homopolymer type b (allyl pentaerythritol crosslinked) water d&c yellow no. 10 fd&c blue no. 1 saccharin sodium methylparaben benzoic acid sodium phosphate, dibasic, anhydrous xanthan gum sodium hydroxide
Indications and Usage:
Indications and usage topex® fluoride gels are indicated for topical application to teeth to aid in the prevention of dental caries. the non-acidic nature of neutral ph (naf) is recommended for patients with ceramic or composite restorations. treatment frequency should not exceed 4 treatments per year.
Warnings and Cautions:
Warnings and precautions do not swallow. harmful if swallowed. keep out of reach of children. may contain fd&c yellow #5 & fd&c yellow #6 this product is not intended for home or unsupervised consumer use. safety and effectiveness below age 3 have not been established. there have been no long-term animal studies with this product to evaluate carcinogenic, mutagenic, or impairment of fertility potential. laboratory studies have indicated that repeated use of apf may dull porcelain, composite restorations and sealants.
Dosage and Administration:
Dosage and administration 1. remove cap from bottle, remove induction seal. do not use if seal is broken. 2. replace cap and shake well. 3. fill applicator tray no more than 1/3 full with fluoride gel. 4. dry tooth surface and insert tray in mouth. 5. use suction throughout treatment. 6. have patient bite down for a minimum of 60 seconds to a maximum of 4 minutes. (a slight biting or chewing motion will provide interproximal coverage) 7. remove tray and have patient expectorate excess gel. do not swallow. 8. instruct patient not to eat, drink, or rinse for 30 minutes after treatment.
Dosage Forms and Strength:
Dosage forms and strengths apf topical gel contains 2.59% sodium fluoride (1.23% fluoride ion). naf topical gel contains 2.0% sodium fluoride (0.9% fluoride ion).
Contraindications:
Contraindications hypersensitivity to fluoride. do not use if patient has a known allergy to fluoride or any of the other ingredients in this product.
Adverse Reactions:
Adverse reactions developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. the following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticarial, gastric distress, headache, and weakness.
Overdosage:
Overdosage if treatment dose is swallowed (less than 100 mg f), administer milk, limewater, or calcium-type antacid. in case of larger doses (1 pint contains 4.5 grams f ion, which is a lethal dose), use ipecac syrup emetic and immediately seek medical help.
Description:
Description topex® fluoride gels are a family of topical fluoride gel products for professional application in trays.
Package Label Principal Display Panel:
Principal display panel - 480 ml bottle label ndc 0699-0701-16 ref ad31130 topex ® neutral ph neutral sodium fluoride gel mint contains 2.0% sodium fluoride (0.9% fluoride ion) rx only sultan ® sultanhealthcare contents: 16 fl oz. (480ml) principal display panel - 480 ml bottle label
Principal display panel - clearly strawberry 16 oz bottle strawberry