Sensodyne Pronamel Multi Action
Potassium Nitrate And Sodium Fluoride
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0135-0568Sensodyne Pronamel Multi Action also known as Potassium Nitrate And Sodium Fluoride is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Sensodyne Pronamel Multi Action is 0135-0568. This drug is available in dosage form of Paste. The names of the active, medicinal ingredients in Sensodyne Pronamel Multi Action drug includes Potassium Nitrate - 50 mg/g Sodium Fluoride - 1.15 mg/g . The currest status of Sensodyne Pronamel Multi Action drug is Active.
Drug Information:
| Drug NDC: | 0135-0568 |
| 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 Multi Action |
| 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: | Multi Action |
| 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) Llc |
| 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: | 09 Dec, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| 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) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1038841
|
| 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 |
|---|
| 0135-0568-04 | 1 TUBE in 1 CARTON (0135-0568-04) / 113 g in 1 TUBE | 09 Dec, 2013 | 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 gentle whitening potassium nitrate and sodium fluoride potassium nitrate nitrate ion sodium fluoride fluoride ion water sorbitol hydrated silica glycerin polyethylene glycol 400 cocamidopropyl betaine titanium dioxide xanthan gum saccharin sodium sodium hydroxide alpine breeze sensodyne pronamel daily protection potassium nitrate and sodium fluoride potassium nitrate nitrate ion sodium fluoride fluoride ion water sorbitol hydrated silica glycerin polyethylene glycol 400 cocamidopropyl betaine xanthan gum saccharin sodium titanium dioxide sodium hydroxide mint essence sensodyne pronamel fresh breath potassium nitrate and sodium fluoride potassium nitrate nitrate ion sodium fluoride fluoride ion water sorbitol hydrated silica glycerin polyethylene glycol 400 cocamidopropyl betaine xanthan gum saccharin sodium titanium dioxide sodium hydroxide fresh wave sensodyne pronamel multi action potassium nitrate and sodium fluoride potassium nitrate nitrate ion sodium fluoride fluoride ion water sorbitol hydrated silica glycerin cocamidopropyl betaine xanthan gum saccharin sodium mica titanium dioxide sodium hydroxide cleansing mint
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 0135-0484-01 sensodyne pronamel toothpaste for sensitive teeth and cavity prevention gentle whitening strengthens and re-hardens enamel protects against the effects of acid erosion* net wt 4.0 oz (113g) wine acids fruit acids soda acids 9 out of 10 dentistsâ recommended brand #1 dentist recommended brand for strengthening & protecting enamelâ multi-action acid protection formula sensodyne pronamel gentle whitening brushing twice a day with pronamel helps to: ⢠protect enamel against the effects of acid erosion ⢠restore natural whiteness ⢠clean effectively and freshen breath ⢠provide cavity protection ⢠maintain healthy teeth and gums pronamel is also suitable for people with sensitive teeth. help protect your enamel against the effects acid erosion. dentists have reported a growing dental health concern due to changing modern diets: â acid erosion â . even teeth without cavities can be affected. *acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. as the enamel becomes thinner, teeth can become visibly less white, weaker, and sensitive. sensodyne pronamel gentle whitening toothpaste is formulated to protect against the effects of acid erosion and also gently, yet effectively remove stains, helping restore teeth to their natural whiteness. as it contains fluoride it also provides all the benefits of a regular toothpaste. #1 dentist recommended brand for strengthening and protecting enamel. â dentists have been recommending sensodyne for the past 20 years. pronamel is from the makers of sensodyne and is highly recommended by dentists. brushing twice a day with pronamel toothpaste strengthens enamel and protects against future acid attacks. and, since pronamel has fluoride it helps protect against cavities too. always follow the label trademarks are owned by or licensed to the gsk group of companies. gsk consumer healthcare warren, nj 07059 ©2017 gsk 106285xa 1-866-844-2797 sensodyne pronamel gentle whitening_4.0 oz.jpg
Principal display panel ndc 0135-0460-01 sensodyne pronamel toothpaste for sensitive teeth and cavity prevention daily protection strengthens and re-hardens enamel protects against the effects of acid erosion* mintessence alpine breeze net wt 4.0 oz (113g) wine acids fruit acids soda acids 9 out of 10 dentistsâ recommended brand #1 dentist recommended brand for strengthening and protecting enamelâ sensodyne pronamel daily protection use whenever you normally brush ⢠freshens breath ⢠helps protect teeth against the effects of acid erosion ⢠strengthens and re-hardens enamel ⢠contains fluoride for cavity protection ⢠suitable for sensitive teeth pronamel is also suitable for people with sensitive teeth. help protect your enamel against the effects of acid erosion. *acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. as the enamel becomes thinner, teeth can become visibly less white, weaker and sensitive. sensodyne pronamel daily protection toothpaste is formulated to help protect against the effects of acid erosion and also gently, yet effectively remove stains, helping restore teeth to their natural whiteness. as it contains fluoride it also provides all the benefits of a regular toothpaste. #1 dentist recommended brand for strengthening and protecting enamel. â dentists have been recommending sensodyne for the past 20 years. pronamel is from the makers of sensodyne and is highly recommended by dentists. brushing twice a day with pronamel toothpaste strengthens enamel and protects against future acid attacks. and, since pronamel toothpaste has fluoride it helps protect against cavities too. always follow the label trademarks are owned by or licensed to the gsk group of companies. gsk consumer healthcare warren, nj 07059 1-866-844-2797 106283xa this product contains no sugar. ©2017 gsk group of companies sensodyne pronamel daily protection_4.0 oz.jpg
Principal display panel ndc 0135-0520-01 sensodyne pronamel toothpaste for sensitive teeth and cavity prevention fresh breath strengthens and re-hardens enamel protects against the effects of acid erosion* fresh wave net wt 4.0 oz (113 g) wine acids fruit acids soda acids 9 out of 10 dentistsâ recommended brand #1 dentist recommended brand for strengthening and protecting enamelâ multi-action acid protecton formula sensodyne pronamel fresh breath brushing twice a day with pronamel helps to: ⢠protect enamel against the effects of acid erosion ⢠freshen breath ⢠strengthen and re-harden enamel ⢠protect against cavities ⢠pronamel is also suitable for people with sensitive teeth help protect your enamel against the effects of acid erosion. *acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. as the enamel becomes thinner, teeth can become visibly less white, weaker and sensitive. sensodyne pronamel fresh breath toothpaste is formulated to help protect against the effects of acid erosion. it also contains fluoride providing the benefits of a regular toothpaste #1 dentist recommended brand for strengthening and protecting enamel. â dentists have been recommending sensodyne for the past 20 years. pronamel is from the makers of sensodyne and is highly recommended by dentists. brushing twice a day with pronamel toothpaste strengthens enamel and protects against future acid attacks. and, since pronamel toothpaste has fluoride it helps protect against cavities too. always follow the label gsk consumer healthcare warren, nj 07059 ©2015 gsk 1-866-844-2797 trademarks are owned by or licensed to the gsk group of companies. 106284xa 5159 sensodyne pronamel fresh breath_4.0 oz.jpg
Principal display panel ndc 0135-0568-04 sensodyne pronamel toothpaste for sensitive teeth and cavity prevention multi-action strengthens and re-hardens enamel protects against the effects of acid erosion* cleansing mint wine acids fruit acids soda acids net wt 4.0 oz (113 g) 9 out of 10 dentistsâ recommended brand #1 dentist recommended brand for strengthening and protecting enamelâ multi-action acid protection formula sensodyne pronamel multi-action brushing twice a day with pronamel helps to: ⢠protect enamel against the effects of acid erosion ⢠restore natural whiteness ⢠clean effectively and freshen breath ⢠provide cavity protection ⢠maintain healthy teeth pronamel is also suitable for people with sensitive teeth. help protect your enamel against the effects of acid erosion. dentists have reported a growing dental health concern due to changing modern diets: â acid erosionâ . even teeth without cavities can be affected. *acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. as the enamel becomes thinner, teeth can become visibly less white, weaker and sensitive. sensodyne pronamel multi-action toothpaste is formulated to help protect against the effects of acid erosion and also gently, yet effectively remove stains, helping restore teeth to their natural whiteness. as it contains fluoride it also provides the benefits of a regular toothpaste. plus, its cleansing mint flavor helps keep your mouth feeling fresh and clean. #1 dentist recommended brand for strengthening and protecting enamel. â dentists have been recommending sensodyne for the past 20 years. pronamel is from the makers of sensodyne and is highly recommended by dentists. brushing twice a day with pronamel toothpaste strengthens enamel and protects against future acid attacks. and, since pronamel toothpaste has fluoride it helps protect against cavities too. always follow the label this product contains no sugar. trademarks are owned by or licensed to the gsk group of companies. gsk consumer healthcare warren, nj 07059 ©2017 gsk group of companies or its licensor. all rights reserved. 1-866-844-2797 106286xa sensodyne pronamel multi-action_4.0 oz.jpg
Further Questions:
Questions or comments? call toll-free 1-866-844-2797