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| Product NDC Code | 0135-0450 | ||||
|---|---|---|---|---|---|
| Drug Name | Sensodyne pronamel mineral boost refreshing peppermint |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 1086243 | ||||
| Application Number | M021 | ||||
| Labeler Name | Haleon US Holdings LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients (refreshing peppermint) water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, titanium dioxide, sodium saccharin
Inactive ingredients (whitening action) water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.
Purpose
Information about the drug product’s indications for use.Purpose Antihypersensitivity Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.SENSODYNE PRONAMEL mineral BOOST refreshing peppermint potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN COCAMIDOPROPYL BETAINE XANTHAN GUM TITANIUM DIOXIDE SACCHARIN SODIUM POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION SENSODYNE PRONAMEL mineral BOOST whitening action potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN COCAMIDOPROPYL BETAINE XANTHAN GUM TITANIUM DIOXIDE SACCHARIN SODIUM SODIUM HYDROXIDE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel NDC 0135-0450-01 SENSODYNE PRONAMEL MINERAL BOOST new TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION Replenishes Vital Minerals For Stronger, Healthier Enamel infused with refreshing peppermint NET WT 4.0 OZ (113g) gsk ©2020 GSK group of companies or its licensor. 62000000049368 Sensodyne Pronamel Mineral Boost refreshing peppermint 4.0 oz carton
Principal Display Panel NDC 0135-0480-01 SENSODYNE PRONAMEL MINERAL BOOST new TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION Replenishes Vital Minerals For Stronger, Healthier Enamel With gentle whitening action NET WT 4.0 OZ (113g) gsk ©2020 GSK group of companies or its licensor. 62000000049369 Sensodyne Pronamel Mineral Boost whitening action 4.0 oz carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information do not store above 25°C (77°F)
Additional Information Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide Minerals keep enamel strong and white. But acidic foods & drinks can dissolve surface minerals. Your saliva naturally replenishes minerals but can’t always keep up, leading to enamel loss. Pronamel Mineral Boost improves natural mineral absorption for strong white teeth, protected from sensitivity. ACIDS DISSOLVE SURFACE MINERALS… …PRONAMEL BOOSTS MINERAL ABSORPTION FROM SALIVA Replenishes vital minerals in enamel. Developed to maximize the effect of fluoride to boost the absorption of calcium & phosphate into the enamel surface. With twice-daily brushing, Pronamel helps to: Protect against effects of dietary acids Prevent enamel loss Relieve sensitive teeth Protect against cavities Clean and freshen your mouth Recyclable Carton Save Water Turn off tap while brushing Trademarks are owned by or licensed to the GSK group of companies. Distributed by: GSK Consumer Healthcare Warren, NJ 07059
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-866-844-2797
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API