NDC 57511-0201 Stance

0.63% Stannous Fluoride Concentrate Rinse

NDC Product Code 57511-0201

NDC 57511-0201-1

Package Description: 225 mL in 1 BOTTLE, PUMP

NDC Product Information

Stance with NDC 57511-0201 is a a human over the counter drug product labeled by Elevate Oral Care. The generic name of Stance is 0.63% stannous fluoride concentrate rinse. The product's dosage form is rinse and is administered via topical form.

Labeler Name: Elevate Oral Care

Dosage Form: Rinse - A liquid used to cleanse by flushing.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Stance Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • STANNOUS FLUORIDE 1.2 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • XYLITOL (UNII: VCQ006KQ1E)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Elevate Oral Care
Labeler Code: 57511
FDA Application Number: part355 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 08-25-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Stance Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient Section

Stannous Fluoride 0.63% Rinse Concentrate

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

Keep out of reach of infants and children.

Instructions For Use Section

DirectionsAdults and 6 years of age 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

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 of age

• 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

Otc - Purpose

• aids in the prevention of dental decay

• helps prevent gingivitis • helps control plaque bacteria

• builds increasing protection against painful tooth sensitivity

* Please review the disclaimer below.