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| Product NDC Code | 0135-0486 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sensodyne pronamel intensive enamel repair 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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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 of age: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, PVM/MA copolymer, 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.Purposes Antihypersensitivity Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 SODIUM LACTATE COCAMIDOPROPYL BETAINE TITANIUM DIOXIDE XANTHAN GUM SACCHARIN SODIUM SODIUM HYDROXIDE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Clean Mint SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 SODIUM LACTATE COCAMIDOPROPYL BETAINE TITANIUM DIOXIDE XANTHAN GUM SACCHARIN SODIUM SODIUM HYDROXIDE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Extra Fresh SENSODYNE PRONAMEL Intensive Enamel Repair Whitening potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 SODIUM LACTATE COCAMIDOPROPYL BETAINE TITANIUM DIOXIDE XANTHAN GUM SACCHARIN SODIUM SODIUM HYDROXIDE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Arctic Breeze
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 0135-0492-01 SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION CLEAN MINT Repairs Weakened Enamel * For Strong, Healthy Teeth NET WT 3.4 OZ (96.4 g) SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR * Sensodyne Pronamel Intensive Enamel Repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth. PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL LOCKS IN MINERALS FOR STRONG HEALTHY TEETH Acids in modern diets can weaken your enamel surface. Over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. Once your enamel surface is weakened it needs extra care for the future. With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair helps to: Actively repair acid-weakened enamel Lock in minerals to protect against the effects of acid wear Protect against cavities Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth. Recycle Carton, Tube and Cap Save Water Turn off tap while brushing ALWAYS FOLLOW THE LABEL Trademarks owned or licensed by GSK. ©2022 GSK or licensor. Distributed by: GSK Consumer Healthcare , Warren, NJ 07059 62000000069608 Front Carton Sensodyne Pronamel Intensive Enamel Repair Clean Mint
Principal Display Panel NDC 0135-0486-01 SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION EXTRA FRESH Repairs Weakened Enamel* For Strong, Healthy Teeth NET WT 3.4 OZ (96.4 g) SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR * Sensodyne Pronamel Intensive Enamel Repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth. PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL LOCKS IN MINERALS FOR STRONG HEALTHY TEETH Acids in modern diets can weaken your enamel surface. Over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. Once your enamel surface is weakened it needs extra care for the future. With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair helps to: Actively repair acid-weakened enamel Lock in minerals to protect against the effects of acid wear Protect against cavities Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth. Recycle Carton, Tube and Cap Save Water Turn off tap while brushing ALWAYS FOLLOW THE LABEL Trademarks owned or licensed by GSK. ©2022 GSK or licensor. Distributed by: GSK Consumer Healthcare , Warren, NJ 07059 62000000068911 Front Carton Sensodyne Pronamel Intensive Enamel Repair Extra Fresh
Principal Display Panel NDC 0135-0481-01 SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION WHITENING ARTIC BREEZE Repairs Weakened Enamel* For Strong, Healthy Teeth NET WT 3.4 OZ (96.4 g) SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR WHITENING * Sensodyne Pronamel Intensive Enamel Repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth. PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL LOCKS IN MINERALS FOR STRONG HEALTHY TEETH Acids in modern diets can weaken your enamel surface. Over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. Once your enamel surface is weakened it needs extra care for the future. With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair helps to: Actively repair acid-weakened enamel Lock in minerals to protect against the effects of acid wear Protect against cavities Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth. Recycle Carton, Tube and Cap Save Water Turn off tap while brushing ALWAYS FOLLOW THE LABEL Trademarks owned or licensed by GSK. ©2022 GSK or licensor. Distributed by: GSK Consumer Healthcare , Warren, NJ 07059 62000000068993 Front Carton Sensodyne Pronamel Intensive Enamel Repair Whitening
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.
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 do not store above 25°C (77°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