NDC 0135-5023 Sensodyne Sensitivity And Gum Mint
Stannous Fluoride Paste Oral

Product Information

Product Code0135-5023
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 Sensitivity And Gum Mint
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.
  • Oral - Administration to or by way of the mouth.
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.
01-06-2020
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.
12-31-2023
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)
Flavor(s)MINT (C73404)

Product Packages

NDC 0135-5023-01

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

NDC 0135-5023-02

Package Description: 1 TUBE in 1 CARTON > 23 g in 1 TUBE

Product Details

Sensodyne Sensitivity And Gum Mint is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Sensodyne Sensitivity And Gum Mint is stannous fluoride. The product's dosage form is paste and is administered via oral form.


What are Sensodyne Sensitivity And Gum Mint 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, UNSPECIFIED FORM (UNII: 5HK03SA80J)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)


* Please review the disclaimer below.

Sensodyne Sensitivity And Gum Mint 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, Antihypersensitivity


Uses



  • •aids in the prevention of dental cavities.
  • •helps control bleeding gums.
  • •Helps interfere with harmful effects of plaque associated with gingivitis.
  • •builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

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.
  • •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 maybe signs or symptoms of periodontitis, a serious form of gum disease.

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 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 specifically formulated to help prevent staining.
  • •store below 25°C (77°F)

Inactive Ingredients (Sensitivity & Gum Whitening)



glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin


Inactive Ingredients (Sensitivity & Gum Mint)



glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin


Questions Or Comments?



1-866-844-2797


Principal Display Panel



NDC 0135-5024-01

new

SENSODYNE

WITH FLUORIDE

SENSITIVITY & GUM

IMPROVES GUM HEALTH

WHITENING

LOW ABRASION FORMULA

DUAL ACTION TOOTHPASTE

TOOTHPASTE FOR SENSITIVE TEETH, GINGIVITIS AND CAVITY PREVENTION

NET WT 3.4 OZ (96.4g)

#1 Dentist Recommended Brand for Sensitive Teeth

Why use Sensodyne Sensitivity & Gum?

Sensodyne Sensitivity & Gum contains a clinically proven ingredient to relieve tooth sensitivity & improve gum health. It builds a protective layer over sensitive areas, effectively relieving tooth sensitivity. It targets and removes plaque bacteria associated with gingivitis, to help reduce swollen, bleeding gums. You can deal with both these concerning problems with one specialist toothpaste. Sensodyne Sensitivity & Gum is a daily fluoride toothpaste.

SENSITIVE AREAS AND SWOLLEN BLEEDING GUMS

BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS

TARGETS & HELPS REMOVE PLAQUE BACTERIA

RELIEVES TOOTH SENSITIVITY* & IMPROVES GUM HEALTH

*with twice daily brushing

Dual Action forTOOTH SENSITIVITY & GUM PROBLEMS

ALWAYS FOLLOW THE LABEL

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

©2019 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

62000000039060

NDC 0135-5023-01

new

SENSODYNE

WITH FLUORIDE

SENSITIVITY & GUM

IMPROVES GUM HEALTH

MINT

LOW ABRASION FORMULA

DUAL ACTION TOOTHPASTE

TOOTHPASTE FOR SENSITIVE TEETH, GINGIVITIS AND CAVITY PREVENTION

NET WT 3.4 OZ (96.4 g)

#1 Dentist Recommended Brand for Sensitive Teeth

Why use Sensodyne Sensitivity & Gum?

Sensodyne Sensitivity & Gum contains a clinically proven ingredient to relieve tooth sensitivity & improve gum health. It builds a protective layer over sensitive areas, effectively relieving tooth sensitivity. It targets and removes plaque bacteria associated with gingivitis, to help reduce swollen, bleeding gums. You can deal with both these concerning problems with one specialist toothpaste. Sensodyne Sensitivity & Gum is a daily fluoride toothpaste.

SENSITIVE AREAS AND SWOLLEN BLEEDING GUMS

BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS

TARGETS & HELPS REMOVE PLAQUE BACTERIA

RELIEVES TOOTH SENSITIVITY* & IMPROVES GUM HEALTH

*with twice daily brushing

Dual Action forTOOTH SENSITIVITY & GUM PROBLEMS

ALWAYS FOLLOW THE LABEL

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

©2019 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

62000000039090


* Please review the disclaimer below.