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| Product NDC Code | 0135-0603 | ||||
|---|---|---|---|---|---|
| Drug Name | Sensodyne pronamel strong and bright enamel extra fresh |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 1086243 | ||||
| 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% 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 Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, 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 Strong and Bright Enamel Mint potassium nitrate and sodium fluoride WATER HYDRATED SILICA SORBITOL GLYCERIN POLYETHYLENE GLYCOL 400 COCAMIDOPROPYL BETAINE TITANIUM DIOXIDE XANTHAN GUM SACCHARIN SODIUM SODIUM HYDROXIDE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Sensodyne Pronamel Strong and Bright Enamel Extra Fresh potassium nitrate and sodium fluoride WATER HYDRATED SILICA SORBITOL GLYCERIN POLYETHYLENE GLYCOL 400 COCAMIDOPROPYL BETAINE TITANIUM DIOXIDE XANTHAN GUM 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 0135-0602-01 SENSODYNE PRONAMEL STRONG & Bright ENAMEL TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION STRONG ENAMEL WHITER TEETH* MINT No. 1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING AND PROTECTING ENAMEL *vs. ProNamel Daily Protection NET WT 3.0 OZ (85 g) Enamel is the vital layer of protection for your teeth and keeping it strong is so important. Sensodyne ProNamel STRONG & Bright ENAMEL gives you whiter teeth* while actively helping to strengthen your tooth enamel and protect against everyday acids. *vs. ProNamel Daily Protection With twice daily brushing, the dual action formulation: Delivers minerals into the enamel to help STRENGTHEN & PROTECT. Polishes away stains for WHITER BRIGHTER TEETH. FRESHENS breath and fights CAVITIES GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2017 GSK group of companies or its licensor ALWAYS FOLLOW THE LABEL 105491XC 105491XC_ProNamel Strong & Bright_3.0 oz.JPG
Principal Display Panel NDC 0135-0603-01 SENSODYNE PRONAMEL STRONG & Bright ENAMEL TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION STRONG ENAMEL WHITER TEETH* EXTRA FRESH No. 1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING AND PROTECTING ENAMEL *vs. ProNamel Daily Protection NET WT 3.0 OZ (85 g) Enamel is the vital layer of protection for your teeth and keeping it strong is so important. Sensodyne ProNamel STRONG & Bright ENAMEL gives you whiter teeth* while actively helping to strengthen your tooth enamel and protect against everyday acids. *vs. ProNamel Daily Protection With twice daily brushing, the dual action formulation: Delivers minerals into the enamel to help STRENGTHEN & PROTECT. Polishes away stains for WHITER BRIGHTER TEETH. FRESHENS breath and fights CAVITIES GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2017 GSK group of companies or its licensor. ALWAYS FOLLOW THE LABEL 105488XC 105488XC_ProNamel Strong and Bright Enamel Extra Fresh_3 oz.JPG
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 store below 25°C (77°F)
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.
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