NDC 0135-0579 Sensodyne True White
Potassium Nitrate And Sodium Fluoride Paste Dental

Product Information

Product Code0135-0579
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.
Sensodyne True White
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.
Potassium Nitrate And Sodium 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.
12-21-2015
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

Flavor(s)MINT (C73404)
MINT (C73404 - EXTRA FRESH)

Product Packages

NDC 0135-0579-01

Package Description: 1 TUBE in 1 CARTON > 85 g in 1 TUBE

Product Details

Sensodyne True White is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Sensodyne True White is potassium nitrate and sodium fluoride. The product's dosage form is paste and is administered via dental form.


What are Sensodyne True White 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.

  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)


* Please review the disclaimer below.

Sensodyne True White 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 Ingredients



Potassium nitrate 5%**

Sodium fluoride 0.25% (0.16% w/v fluoride ion)


Purpose



Antihypersensitivity

Anticavity


Uses



  • •builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • •aids in the prevention of dental cavities.

When Using This Product,



if irritation occurs discontinue use.


Stop Use And Ask A Dentist If



  • •the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • •pain/sensitivity still persists after 4 weeks of use.

Keep Out Of Reach Of Children.



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


Directions



  • Adults and children 12 years of age and older:
    • •Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    • •Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
    • Children under 12 years: Consult a dentist or doctor.

Other Information



  • •store below 30°C (86°F)

Inactive Ingredients



sorbitol, water, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin


Questions Or Comments?



Call toll-free 1-866-844-2797


Principal Display Panel



NDC 0135-0581-01

SENSODYNE®

TRUE

white®

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

MINT

Sensitivity Relief*

Stain Prevention • Stain Removal

CLINICALLY PROVEN INGREDIENT FOR SENSITIVITY RELIEF*

No. 1 DENTIST RECOMMENDED BRAND

FOR SENSITIVE TEETH

NET WT 3.0 OZ (85 g)

Brushing with abrasive toothpaste can wear the sensitive areas of your teeth. Sensodyne® True White® has the lowest abrasion formulation ever in a Sensodyne® toothpaste.

With twice daily brushing it:

  • •is proven to relieve sensitivity pain
  • •helps to gently whiten your teeth
  • •leaves a protective shield to help prevent new stains forming
  • •freshens breath, fights cavities and helps keep gums healthy
  • *with twice daily brushing

    **maximum FDA sensitivity active ingredient

    GSK Consumer Healthcare

    Warren, NJ 07059

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

    ©2015 GSK group of companies or its licensor. All rights reserved

    ALWAYS FOLLOW THE LABEL

    105639XA

    NDC 0135-0579-01

    SENSODYNE®

    TRUE

    white®

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    EXTRA FRESH

    Sensitivity Relief*

    Stain Prevention • Stain Removal

    CLINICALLY PROVEN INGREDIENT FOR SENSITIVITY RELIEF*

    No. 1 DENTIST RECOMMENDED BRAND

    FOR SENSITIVE TEETH

    NET WT 3.0 OZ (85 g)

    Brushing with abrasive toothpaste can wear the sensitive areas of your teeth. Sensodyne® True White® has the lowest abrasion formulation ever in a Sensodyne® toothpaste.

    With twice daily brushing it:

    • •is proven to relieve sensitivity pain
    • •helps to gently whiten your teeth
    • •leaves a protective shield to help prevent new stains forming
    • •freshens breath, fights cavities and helps keep gums healthy
    • *with twice daily brushing

      **maximum FDA sensitivity active ingredient

      GSK Consumer Healthcare

      Warren, NJ 07059

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

      ©2015 GSK group of companies or its licensor. All rights reserved.

      ALWAYS FOLLOW THE LABEL

      105640XA


* Please review the disclaimer below.