Curodont Repair Fluoride Plus
Sodium Fluoride
Credentis Ag
Human Otc Drug
NDC 72247-101Curodont Repair Fluoride Plus also known as Sodium Fluoride is a human otc drug labeled by 'Credentis Ag'. National Drug Code (NDC) number for Curodont Repair Fluoride Plus is 72247-101. This drug is available in dosage form of Sponge. The names of the active, medicinal ingredients in Curodont Repair Fluoride Plus drug includes Sodium Monofluorophosphate - .02 g/100mL . The currest status of Curodont Repair Fluoride Plus drug is Active.
Drug Information:
| Drug NDC: | 72247-101 |
| 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: | Curodont Repair Fluoride Plus |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc 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: | Credentis Ag |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Sponge |
| 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 MONOFLUOROPHOSPHATE - .02 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | OTC MONOGRAPH FINAL |
| 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: | 11 Jan, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| 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. |
| Application Number: | part355 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | CREDENTIS AG
|
| 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. |
| UPC: | 7649991541159
|
| UPC stands for Universal Product Code. |
| UNII: | C810JCZ56Q
|
| 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 |
|---|
| 72247-101-12 | 10 CYLINDER in 1 BOX (72247-101-12) / .1 mL in 1 CYLINDER (72247-101-11) | 11 Jan, 2019 | 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. |
Purpose:
Purpose anticavity
Product Elements:
Curodont repair fluoride plus sodium fluoride water chlorhexidine gluconate tromethamine trehalose dihydrate oligopeptide-10 hypromellose, unspecified sodium monofluorophosphate fluoride ion
Indications and Usage:
Uses aids in the prevention of dental cavities anticavity dental rinse restores enamel for the treatment of white spots
Warnings:
Warning for topical intraoral use only. for professional office use only. this product is not intended for home or unsupervised consumer use.
Dosage and Administration:
Directions usual dosage is one treatment per tooth. after prophylaxis treatment, remove the pellicle of the concerned tooth by using 2% sodium hypochlorite for 10 seconds. rinse the tooth surface with water. remove inorganic deposits by pushing together the two cylinders and apply product with sponge on treatment area. after treatment time of five minutes have patient expectorate residues. for maximum benefits for the prevention of caries, instruct patient not to rinse, eat or drink for 30 minutes. for patients with rampant or active caries, repeat treatment once or twice every six months.
Package Label Principal Display Panel:
Vvardis professional switzerland curodont (tm) repair fluoride plus vvardis technology anticavity dental treatment rinse contains 10 single packed single use applicator with 0.1ml rinse each 10 x 0.1 ml (10 x 0.033 fl oz) important: read directions for proper use - see inside curodont repair fluoride p1 curodont repair fluoride p2 curodont repair fluoride 1unit