Stance
0.63% Stannous Fluoride Concentrate Rinse
Elevate Oral Care
Human Otc Drug
NDC 57511-0202Stance also known as 0.63% Stannous Fluoride Concentrate Rinse is a human otc drug labeled by 'Elevate Oral Care'. National Drug Code (NDC) number for Stance is 57511-0202. This drug is available in dosage form of Rinse. The names of the active, medicinal ingredients in Stance drug includes Stannous Fluoride - 1.2 mg/mL . The currest status of Stance drug is Active.
Drug Information:
| Drug NDC: | 57511-0202 |
| 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: | Stance |
| 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: | 0.63% Stannous Fluoride Concentrate Rinse |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Elevate Oral Care |
| 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: | STANNOUS FLUORIDE - 1.2 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 25 Aug, 2016 |
| 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: | Elevate Oral Care
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 583459
|
| 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: | 3FTR44B32Q
|
| 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 |
|---|
| 57511-0202-1 | 225 mL in 1 BOTTLE, PUMP (57511-0202-1) | 25 Aug, 2016 | 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:
⢠aids in the prevention of dental decay ⢠helps prevent gingivitis ⢠helps control plaque bacteria ⢠builds increasing protection against painful tooth sensitivity
Product Elements:
Stance 0.63% stannous fluoride concentrate rinse glycerin xylitol stannous fluoride fluoride ion tropical breeze
Indications and Usage:
Indications & usage section uses ⢠aids in the prevention of dental decay ⢠helps prevent gingivitis ⢠helps control plaque bacteria ⢠builds increasing protection against painful tooth sensitivity warnings section warnings ⢠when using this product do not use for sensitivity longer than four weeks unless recommended by a dentist ⢠stop use and ask a dentist if sensitivity persists or worsens because sensitive teeth may indicate a serious problem that may need prompt care keep out of reach of children. if more than used for rinsing is accidentally swallowed, seek medical attention or contact a poison control center immediately. otc - keep out of reach of children section keep out of reach of infants and children. instructions for use section directions adults and children 6 years and older: ⢠do not use before mixing with water ⢠use immediately after preparing rinse ⢠use once daily after brushing your teeth with a toothpaste or as directed
Read more... by your dentist ⢠remove cap and replace with pump ⢠rotate spout counter clockwise to extend ⢠depress pump until medicine comes to the tip of the pump ⢠make 2 complete pump depressions into cup provided (1/8 oz) ⢠add tap water to line (1 oz) on cup ⢠close cap and shake to mix ⢠vigorously swish 1/2 oz for one minute then spit out and repeat with second 1/2 oz ⢠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 inactive ingredient section inactive ingredients glycerin, xylitol, flavor otc - questions section questions? 1-877-866-9113 or visit our website at www.elevateoralcare.com
Warnings:
Warnings section warnings ⢠when using this product do not use for sensitivity longer than four weeks unless recommended by a dentist ⢠stop use and ask a dentist if sensitivity persists or worsens because sensitive teeth may indicate a serious problem that may need prompt care keep out of reach of children. if more than used for rinsing is accidentally swallowed, seek medical attention or contact a poison control center immediately. otc - keep out of reach of children section keep out of reach of infants and children. instructions for use section directions adults and children 6 years and older: ⢠do not use before mixing with water ⢠use immediately after preparing rinse ⢠use once daily after brushing your teeth with a toothpaste or as directed by your dentist ⢠remove cap and replace with pump ⢠rotate spout counter clockwise to extend ⢠depress pump until medicine comes to the tip of the pump ⢠make 2 complete pump depressions into cup
Read more...provided (1/8 oz) ⢠add tap water to line (1 oz) on cup ⢠close cap and shake to mix ⢠vigorously swish 1/2 oz for one minute then spit out and repeat with second 1/2 oz ⢠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 inactive ingredient section inactive ingredients glycerin, xylitol, flavor otc - questions section questions? 1-877-866-9113 or visit our website at www.elevateoralcare.com
Dosage and Administration:
Make 2 complete pump depressions into cup provided (1/8 oz) ⢠add tap water to line (1 oz) on cup ⢠close cap and shake to mix ⢠vigorously swish 1/2 oz for one minute then spit out and repeat with second 1/2 oz ⢠do not swallow the rinse
Package Label Principal Display Panel:
Package label.principal display panel stannous fluoride 0.63% rinse concentrate label
Further Questions:
Otc - questions section questions? 1-877-866-9113 or visit our website at www.elevateoralcare.com