Nupro Fluorides Wild Cherry
Sodium Fluoride
Dentsply Llc. Professional Division Trading As "dentsply Professional"
Human Prescription Drug
NDC 65222-431Nupro Fluorides Wild Cherry also known as Sodium Fluoride is a human prescription drug labeled by 'Dentsply Llc. Professional Division Trading As "dentsply Professional"'. National Drug Code (NDC) number for Nupro Fluorides Wild Cherry is 65222-431. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Nupro Fluorides Wild Cherry drug includes Sodium Fluoride - 25.9 mg/g . The currest status of Nupro Fluorides Wild Cherry drug is Active.
Drug Information:
| Drug NDC: | 65222-431 |
| 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: | Nupro Fluorides Wild Cherry |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Nupro Fluorides |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Wild Cherry |
| 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 "dentsply Professional" |
| 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 - 25.9 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: | 19 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 "DENTSPLY Professional"
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1993077
1993079
|
| 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: | 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 |
|---|
| 65222-431-44 | 7 g in 1 BOTTLE, PLASTIC (65222-431-44) | 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:
Nupro fluorides wild cherry sodium fluoride sodium fluoride fluoride ion hydrofluoric acid methylparaben carbomer homopolymer type b (allyl pentaerythritol crosslinked) phosphoric acid benzoic acid fd&c red no. 40 water xanthan gum saccharin sodium wild cherry nupro fluorides bubble gum sodium fluoride sodium fluoride fluoride ion hydrofluoric acid methylparaben carbomer homopolymer type b (allyl pentaerythritol crosslinked) phosphoric acid benzoic acid fd&c red no. 40 water xanthan gum saccharin sodium
Indications and Usage:
Indications and usage for topical application to aid in the protection against dental caries.
Warnings and Cautions:
Warnings and precautions do not swallow. keep out of reach of children. 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. dispense a narrow ribbon of gel into applicator trays. 4. air dry teeth thoroughly and insert trays in mouth with head tilted slightly forward. 5. instruct patient to continue light biting action for 1 minute (or up to 4 minutes). a slight chewing motion enhances interproximal coverage. 6. use suction throughout treatment. 7. have patient expectorate after treatment. 8. instruct patient not to eat, drink, or rinse for 30 minutes. recommended frequency: not to exceed four 4 treatments per year.
Contraindications:
Contraindications hypersensitivity to fluoride.
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, urticaria, 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.
How Supplied:
How supplied 2.59% sodium fluoride (1.23% fluoride ion) gel supplied in 12 fl. oz. bottles.
Package Label Principal Display Panel:
Principal display panel - wild cherry wild cherry
Pricipal display panel - bubble gum bubble gum