NDC 0135-5026 Sensodyne Nourish Gently Soothing

Potassium Nitrate And Sodium Fluoride

NDC Product Code 0135-5026

NDC CODE: 0135-5026

Proprietary Name: Sensodyne Nourish Gently Soothing 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.

Non-Proprietary Name: Potassium Nitrate And Sodium Fluoride 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.

Product Characteristics

Color(s):
WHITE (C48325)
Flavor(s):
MINT (C73404)

NDC Code Structure

  • 0135 - Glaxosmithkline Consumer Healthcare Holdings (us) Llc

NDC 0135-5026-01

Package Description: 1 TUBE in 1 CARTON > 113 g in 1 TUBE

NDC Product Information

Sensodyne Nourish Gently Soothing with NDC 0135-5026 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Sensodyne Nourish Gently Soothing is potassium nitrate and sodium fluoride. The product's dosage form is paste and is administered via dental form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1086243.

Dosage Form: Paste - 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.

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.

Sensodyne Nourish Gently Soothing 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.


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.

  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0135
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 01-03-2022 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Sensodyne Nourish Gently Soothing Product Label Images

Sensodyne Nourish Gently Soothing 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

Active Ingredients

Potassium nitrate 5%Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Purposes

AntihypersensitivityAnticavity

Uses

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

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

  • •do not store above 25°C (77°F)

Inactive Ingredients

Water, sorbitol, hydrated silica, glycerin, flavor (contains aloe barbadensis extract and cocos nucifera (coconut) oil), sodium lauryl sulfate, xanthan gum, cocamidopropyl betaine, sodium saccharin, titanium dioxide

Additional Information

  • ALWAYS FOLLOW THE LABELSENSODYNE nourishWITH BIO-ACTIVE MINERALSBrush twice daily for a healthier smile: •Strengthens & nourishes teeth •Helps prevent cavities •Protects from sensitivity* •Freshens breathThe Sensodyne Nourish range with bio-active minerals, strengthens and nourishes teeth while also protecting from sensitivity*. Our toothpaste is designed to provide the everyday nourishment your teeth to help protect the health of your mouth.Gently Soothing: With trusted sensitivity protection*, our formulation, blended with aloe vera extract and natural mint, is designed for a clean sensation.*with twice daily brushHelp us support the planet by recycling our packaging and being responsible with water usage.CARTONRECYCLETUBERECYCLELOTSee end of cartonSave WaterTurn off tap whilst brushingTrademarks are owned by or licensed to the GSK group of companies.©2021 GSK group of companies or its licensor.Distributed by:GSK Consumer HealthcareWarren, NJ 07059

* Please review the disclaimer below.