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| Product NDC Code | 0135-0579 | ||||
|---|---|---|---|---|---|
| Drug Name | Sensodyne true white |
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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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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Potassium nitrate 5%** Sodium fluoride 0.25% (0.16% 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: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients sorbitol, water, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin
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 True white potassium nitrate and sodium fluoride SORBITOL WATER GLYCERIN HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE ANHYDROUS POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE SODIUM METHYL COCOYL TAURATE COCAMIDOPROPYL BETAINE XANTHAN GUM SODIUM HYDROXIDE SACCHARIN SODIUM POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Sensodyne True white potassium nitrate and sodium fluoride SORBITOL WATER GLYCERIN HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE ANHYDROUS POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE SODIUM METHYL COCOYL TAURATE COCAMIDOPROPYL BETAINE XANTHAN GUM SODIUM HYDROXIDE SACCHARIN SODIUM POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION extra fresh
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 0135-0581-01 SENSODYNE ® TRUE white ® TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION MINT Sensitivity Relief* Stain Prevention • Stain Removal CLINICALLY PROVEN INGREDIENT FOR SENSITIVITY RELIEF* No. 1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH NET WT 3.0 OZ (85 g) Brushing with abrasive toothpaste can wear the sensitive areas of your teeth. Sensodyne ® True White ® has the lowest abrasion formulation ever in a Sensodyne ® toothpaste. With twice daily brushing it: is proven to relieve sensitivity pain helps to gently whiten your teeth leaves a protective shield to help prevent new stains forming freshens breath, fights cavities and helps keep gums healthy *with twice daily brushing **maximum FDA sensitivity active ingredient GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2015 GSK group of companies or its licensor. All rights reserved ALWAYS FOLLOW THE LABEL 105639XA 105639XA_Sensodyne True White mint_3.0 oz.JPG
Principal Display Panel NDC 0135-0579-01 SENSODYNE ® TRUE white ® TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION EXTRA FRESH Sensitivity Relief* Stain Prevention • Stain Removal CLINICALLY PROVEN INGREDIENT FOR SENSITIVITY RELIEF* No. 1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH NET WT 3.0 OZ (85 g) Brushing with abrasive toothpaste can wear the sensitive areas of your teeth. Sensodyne ® True White ® has the lowest abrasion formulation ever in a Sensodyne ® toothpaste. With twice daily brushing it: is proven to relieve sensitivity pain helps to gently whiten your teeth leaves a protective shield to help prevent new stains forming freshens breath, fights cavities and helps keep gums healthy *with twice daily brushing **maximum FDA sensitivity active ingredient GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2015 GSK group of companies or its licensor. All rights reserved. ALWAYS FOLLOW THE LABEL 105640XA 105640XA_Sensodyne True White Extra Fresh_3.0 oz.JPG
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? Call toll-free 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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product, if irritation occurs discontinue use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store below 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 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.
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