Sensodyne Pronamel Intensive Enamel Repair Whitening
Potassium Nitrate And Sodium Fluoride
Glaxosmithkline Consumer Healthcare Holdings (us)
Human Otc Drug
NDC 0135-0481Sensodyne Pronamel Intensive Enamel Repair Whitening also known as Potassium Nitrate And Sodium Fluoride is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us)'. National Drug Code (NDC) number for Sensodyne Pronamel Intensive Enamel Repair Whitening is 0135-0481. This drug is available in dosage form of Paste. The names of the active, medicinal ingredients in Sensodyne Pronamel Intensive Enamel Repair Whitening drug includes Potassium Nitrate - 50 mg/g Sodium Fluoride - 1.15 mg/g . The currest status of Sensodyne Pronamel Intensive Enamel Repair Whitening drug is Active.
Drug Information:
| Drug NDC: | 0135-0481 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sensodyne Pronamel Intensive Enamel Repair Whitening |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Sensodyne Pronamel |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Intensive Enamel Repair Whitening |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Potassium Nitrate And Sodium Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Paste |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | POTASSIUM NITRATE - 50 mg/g
SODIUM FLUORIDE - 1.15 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 06 Jan, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part356 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | GlaxoSmithKline Consumer Healthcare Holdings (US)
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1086243
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | RU45X2JN0Z
8ZYQ1474W7
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0135-0481-01 | 1 TUBE in 1 CARTON (0135-0481-01) / 96.4 g in 1 TUBE | 06 Jan, 2020 | N/A | No |
| 0135-0481-02 | 2 TUBE in 1 CARTON (0135-0481-02) / 96.4 g in 1 TUBE | 06 Jan, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antihypersensitivity anticavity
Product Elements:
Sensodyne pronamel intensive enamel repair clean mint potassium nitrate and sodium fluoride potassium nitrate nitrate ion sodium fluoride fluoride ion water sorbitol hydrated silica glycerin polyethylene glycol 400 sodium lactate cocamidopropyl betaine titanium dioxide xanthan gum saccharin sodium sodium hydroxide clean mint sensodyne pronamel intensive enamel repair extra fresh potassium nitrate and sodium fluoride potassium nitrate nitrate ion sodium fluoride fluoride ion water sorbitol hydrated silica glycerin polyethylene glycol 400 sodium lactate cocamidopropyl betaine titanium dioxide xanthan gum saccharin sodium sodium hydroxide extra fresh sensodyne pronamel intensive enamel repair whitening potassium nitrate and sodium fluoride potassium nitrate nitrate ion sodium fluoride fluoride ion water sorbitol hydrated silica glycerin polyethylene glycol 400 sodium lactate cocamidopropyl betaine titanium dioxide xanthan gum saccharin sodium sodium hydroxide arctic breeze
Indications and Usage:
Uses ⢠builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. ⢠aids in the prevention of dental cavities.
Warnings:
Warnings 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.
When Using:
When using this product, if irritation occurs discontinue use.
Dosage and Administration:
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.
Stop 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.
Package Label Principal Display Panel:
Principal display panel ndc 0135-0492-01 sensodyne pronamel intensive enamel repair toothpaste for sensitive teeth and cavity prevention clean mint actively repairs weakened enamel* net wt 3.4 oz (96.4 g) sensodyne pronamel intensive enamel repair * sensodyne pronamel intensive enamel repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth. pronamel actively repairs weakened enamel locks in minerals for strong healthy teeth acids in modern diets can weaken your enamel surface. over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. once your enamel surface is weakened it needs extra care for the future. with twice-daily brushing, sensodyne pronamel intensive enamel repair helps to: ⢠actively repair acid-weakened enamel ⢠lock in minerals to protect against the effects of acid wear ⢠protect against cavities sensodyne pronamel intensive enamel repair is suitable for sensitive teeth. always follow the label trademarks owned or licensed by gsk. ©2018 gsk or licensor. distributed by: gsk consumer healthcare warren, nj 07059 62000000030303 sensodyne pronamel\62000000030303_sensodyne pronamel intensive enamel clean mint_3.4 oz.jpg
Principal display panel ndc 0135-0486-01 sensodyne pronamel intensive enamel repair toothpaste for sensitive teeth and cavity prevention extra fresh actively repairs weakened enamel* net wt 3.4 oz (96.4 g) sensodyne pronamel intensive enamel repair * sensodyne pronamel intensive enamel repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth. pronamel actively repairs weakened enamel locks in minerals for strong healthy teeth acids in modern diets can weaken your enamel surface. over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. once your enamel surface is weakened it needs extra care for the future. with twice-daily brushing, sensodyne pronamel intensive enamel repair helps to: ⢠actively repair acid-weakened enamel ⢠lock in minerals to protect against the effects of acid wear ⢠protect against cavities sensodyne pronamel intensive enamel repair is suitable for sensitive teeth. always follow the label trademarks owned or licensed by gsk. ©2018 gsk or licensor. distributed by: gsk consumer healthcare warren, nj 07059 62000000030306 sensodyne pronamel\62000000030306_sensodyne pronamel intensive enamel extra fresh_3.4 oz.jpg
Principal display panel ndc 0135-0481-01 new sensodyne pronamel intensive enamel repair toothpaste for sensitive teeth and cavity prevention whitening actively repairs weakened enamel* net wt 3.4 oz (96.4 g) sensodyne pronamel intensive enamel repair whitening * sensodyne pronamel intensive enamel repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth. pronamel actively repairs weakened enamel locks in minerals for strong healthy teeth actively repairs enamel weakened by dietary acids and helps whiten teeth with twice-daily brushing, sensodyne pronamel intensive enamel repair whitening helps to: ⢠lock in minerals to protect against the effects of acid wear ⢠protect against cavities ⢠effectively removes stains to whiten teeth ⢠restore natural whiteness of teeth sensodyne pronamel intensive enamel repair is suitable for sensitive teeth. always follow the label trademarks owned or licensed to the gsk group of companies. ©2019 gsk group of companies or licensor. distributed by: gsk consumer healthcare warren, nj 07059 620000000371915 sensodyne pronamel intensive enamel repair whitening
Further Questions:
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