Closys Silver Sensitive Mouth Rinse Fluoride Rinse
Sodium Fluoride
Rowpar Pharmaceuticals, Inc.
Human Otc Drug
NDC 58578-0517Closys Silver Sensitive Mouth Rinse Fluoride Rinse also known as Sodium Fluoride is a human otc drug labeled by 'Rowpar Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Closys Silver Sensitive Mouth Rinse Fluoride Rinse is 58578-0517. This drug is available in dosage form of Rinse. The names of the active, medicinal ingredients in Closys Silver Sensitive Mouth Rinse Fluoride Rinse drug includes Sodium Fluoride - .02 g/100mL . The currest status of Closys Silver Sensitive Mouth Rinse Fluoride Rinse drug is Active.
Drug Information:
| Drug NDC: | 58578-0517 |
| 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: | Closys Silver Sensitive Mouth Rinse Fluoride Rinse |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Closys Silver Sensitive Mouth Rinse |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Fluoride Rinse |
| 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 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: | Rowpar Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Rinse |
| 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 - .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: | 01 Jan, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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: | Rowpar Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 313029
|
| 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 |
|---|
| 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:
Closys silver sensitive mouth rinse fluoride rinse sodium fluoride sodium fluoride fluoride ion water chlorine dioxide sodium phosphate, tribasic, dodecahydrate anhydrous citric acid peppermint sucralose label carton
Indications and Usage:
Uses ⪠aids in the prevention of dental cavities
Warnings:
Warnings
Dosage and Administration:
Directions adults and children 6 years of age and older use twice a day after brushing your teeth with a toothpaste pour out and vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 6 years consult a dentist or doctor
Package Label Principal Display Panel:
Packaging a cleaner mouth a healthier you ® clÅsys ® silver ® anticavity fluoride mouth rinse healthy teeth sensitive mouth rinse with fluoride helps rebuild weakened tooth enamel & reverse early tooth decay protects against cavities freshens breath non burning, alcohol free gentle ph balanced gentle mint 32 fl oz (946 ml) 52532-30 distributed by: rowpar pharmaceuticals, inc. bridgewater, nj 08807 1 (800) 643-3337 closys.com this bottle is recyclable. please support recycling in your community 52532-31 non-burning, non-irritating formula new look! a cleaner mouth a healthier you ® clÅsys ® silver ® anticavity fluoride mouth rinse healthy teeth helps rebuild weakened tooth enamel & reverse early tooth decay strengthens teeth & improves their appearance protects against cavities freshens breath non burning, alcohol free gentle ph balanced gentle mint 32 fl oz (946 ml) a cleaner mouth a healthier you ® clÅsys ® silver ® serious science for sensitive mouths ⢠how does closys ® silver with flouride work? closys ® silver healthy teeth mouth rinse contains fluoride to help protect against cavities. with regular use, it helps rebuild weakened tooth enamel, reverse early tooth decay, and strengthen teeth to improve their appearance. the patented dual action formula contains cloralstan ® which kills bad breath bacteria and neutralizes sulfur mouth odor molecules for long lasting fresh breath. closys ® silver healthy teeth mouth rinse does not contain alcohol, sulfates, triclosan, and other ingredients that can burn or irritate the mouth so you can rinse longer to get great results! healthy mouth = healthy body gentlest. oral care. ever. ® a cleaner mouth a healthier you ® clÅsys ® silver ® serious science for sensitive mouths ⢠our story founder of closys ® & periodontist dr. perry ratcliff had a bold belief that there had to be a better/gentler way to help with oral care. dr. ratcliff didn't agree with the common myth âif it hurts, it must be good for you.â closys ® took a different approachâkeep it gentle, yet effective, and people will use it long enough to make a difference in their oral health. after discovering that his first patented formula was not only extremely gentle but incredibly effective, he gathered a small group of dental professionals and business leaders to start their journey toward what is today closys ® oral care what makes closys ® product different? simply put, closys ® is the gentlest. oral care. ever. ® all closys ® formulas are ph balanced, highly effective and extremely gentle so they are not harsh or irritating to sensitive mouths. and because itâs so gentle, it means you can swish it in your mouth longer without having to spit it out early and risk not getting the full benefit of the rinse. closys ® products are free of alcohol, sulfates, triclosan, and other harsh ingredients that can burn or irritate sensitive mouths. distributed by: rowpar pharmaceuticals, inc. bridgewater, nj 08807 1 (800) 643-3337 closys.com this bottle is recyclable. please support recycling in your community 55016-19
Further Questions:
Questions or comments? call 1-800-643-3337