NDC 0135-0710 Polident Propartial
Stannous Fluoride Paste Dental

Product Information

Product Code0135-0710
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Polident Propartial
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Stannous Fluoride
Product Type 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.
Human Otc Drug
Dosage FormPaste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Dental - Administration to a tooth or teeth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0135
FDA Application Number 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.
part356
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-04-2021
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)WHITE (C48325)

Product Packages

NDC 0135-0710-01

Package Description: 1 TUBE in 1 CARTON > 96.4 g in 1 TUBE

NDC 0135-0710-02

Package Description: 1 TUBE in 1 CARTON > 65.2 g in 1 TUBE

NDC 0135-0710-03

Package Description: 1 TUBE in 1 CARTON > 22.7 g in 1 TUBE

Product Details

Polident Propartial is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Polident Propartial is stannous fluoride. The product's dosage form is paste and is administered via dental form.


What are Polident Propartial Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)


* Please review the disclaimer below.

Polident Propartial Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



Stannous fluoride 0.454% (0.15% w/v fluoride ion)


Purposes



Anticavity, Antigingivitis


Uses



  • •aids in the prevention of dental cavities.
  • •helps prevent gingivitis, an early form of gum disease.
  • •helps interfere with harmful effects of plaque associated with gingivitis.

Stop Use And Ask A Dentist If



  • •gingivitis, bleeding, or redness persists for more than 2 weeks.
  • •you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing
  •  between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep Out Of Reach Of Children Under 6 Years Of Age.



If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • adults and children 2 years of age and older:
    • •apply toothpaste onto a toothbrush.
    • •brush teeth thoroughly, preferably after each meal at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • •to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
    • children under 2 years of age: Consult a dentist or doctor.

Other Information



  • •products containing stannous fluoride may produce surface staining of the teeth. Adequate
  •  toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • •this product is specially formulated to help prevent staining.
  • •store below 25°C (77°F)

Inactive Ingredients



glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium

dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin


Questions Or Comments?



1-866-844-2796


Additional Information



ALWAYS FOLLOW THE LABEL

Your partial can act as a bacteria magnet, attracting more odor-causing bacteria, plaque and debris that if not cleaned can damage your natural teeth.

NEW POLIDENT ProPartial is a simple 3-step range specially developed to cleanse partial dentures, help strengthen teeth, and help protect against odor-causing bacteria.

STEP 1PURIFY Your Partial with Foam Cleanser

STEP 2 STRENGHTEN Your Teeth + Gums with Toothpaste

STEP 3 PROTECT Your Teeth with Mouthwash

Strengthens by remineralizing teeth, including vulnerable teeth next to the partial and helps fight plaque bacteria*.

*associated with gingivitis, an early form of gum disease

1-866-844-2796

Distributed by:

GSK Consumer Healthcare, Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2020 GSK group of companies or its licensor.

Made in Germany.

Best used before the end of: see end of carton.


Principal Display Panel



NDC 0135-0710-01

POLIDENT

PROPARTIAL

Fluoride Anticavity and Antigingivitis Toothpaste

new

STEP 2 STRENGTHEN TOOTHPASTE FOR TEETH AND GUMS

* Please review the disclaimer below.