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| Product NDC Code | 0135-0525 | ||||||||||||||||||||
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| Drug Name | Sensodyne extra whitening |
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| Type | Brand | ||||||||||||||||||||
| Active Ingredients |
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| Route | DENTAL | ||||||||||||||||||||
| Dosage Form | PASTE | ||||||||||||||||||||
| RxCUI drug identifier | 1038841 | ||||||||||||||||||||
| Application Number | M022 | ||||||||||||||||||||
| Labeler Name | Haleon US Holdings LLC | ||||||||||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Potassium nitrate (5%) Sensodyne Fresh Mint and Fresh Impact: Sodium fluoride 0.25% (0.15% w/v fluoride ion) Sensodyne Extra Whitening: Sodium fluoride 0.24% (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 (Extra Whitening) water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, cocamidopropyl betaine, sodium methyl cocoyl taurate, xanthan gum, sodium hydroxide, sodium saccharin, sucralose
Inactive ingredients (Fresh Mint) water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1
Inactive ingredients (Fresh Impact) water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, blue 1
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.Purposes Antihypersensitivity Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Sensodyne Extra Whitening potassium nitrate and sodium fluoride WATER HYDRATED SILICA SORBITOL GLYCERIN SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE COCAMIDOPROPYL BETAINE SODIUM METHYL COCOYL TAURATE XANTHAN GUM SODIUM HYDROXIDE SACCHARIN SODIUM SUCRALOSE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Sensodyne Fresh Mint potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN COCAMIDOPROPYL BETAINE XANTHAN GUM TITANIUM DIOXIDE SACCHARIN SODIUM SODIUM HYDROXIDE SUCRALOSE D&C YELLOW NO. 10 FD&C BLUE NO. 1 POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Sensodyne Fresh Impact potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN COCAMIDOPROPYL BETAINE XANTHAN GUM TITANIUM DIOXIDE SACCHARIN SODIUM SODIUM HYDROXIDE SUCRALOSE FD&C BLUE NO. 1 POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION white and blue
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 #1 DENTIST RECOMMENDED BRAND HALEON SENSODYNE Extra Whitening with triple action cleaning formula TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION 24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth What are sensitive teeth? Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity, for example, with cold and hot food and drinks. What does Sensodyne do? Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness. *with twice daily brushing. 24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth Use Sensodyne Extra Whitening twice daily: • Long lasting sensitivity protection• every day • Contains fluoride to protect against cavities NET WT 4.0 OZ (113g) 62000000208004 Front Carton Sensodyne Extra Whitening 4 oz carton
Principal Display Panel #1 Dentist Recommended Brand HALEON SENSODYNE Fresh Mint with triple action cleaning formula TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION 24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth NET WT 4.0 OZ (113 g) What are sensitive teeth? Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity, for example, with cold and hot food and drinks. What does Sensodyne do? Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness. *with twice daily brushing. 24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth Use Sensodyne Fresh Mint twice daily: • Long lasting sensitivity protection• every day • Contains fluoride to protect against cavities 62000000208036 Front Carton Sensodyne Fresh Mint 4 oz carton
Principal Display Panel NDC 0135-0528-04 #1 Dentist Recommended Brand SENSODYNE Fresh Impact TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION 24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth NET WT 4.0 OZ (113g) What are sensitive teeth? Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity, for example, with cold and hot food and drinks. What does Sensodyne do? Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness. *with twice daily brushing 24/7 SENSITIVITY PROTECTION* +Strong & Healthy Teeth Use Sensodyne Fresh Impact twice daily: • Long lasting sensitivity protection• every day • Contains fluoride to protect against cavities 6191 Front Carton Sensodyne Regular Fresh Impact 4 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.Additional Information ALWAYS FOLLOW THE LABEL Trademarks are owned by or licensed to the Haleon group of companies. ©2023 Haleon group of companies or its licensor. Distributed by: Haleon, Warren, NJ 07059 Pat. Info www.productpats.com
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
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
Storage and handling
Information about safe storage and handling of the drug product.Other information do not store above 30°C (86°F)
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