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| Product NDC Code | 0135-0520 | ||||||||||
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| Drug Name | Sensodyne pronamel fresh breath |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||||
| 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% 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 (Gentle Whitening) water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide
Inactive ingredients (Daily Protection) water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide
Inactive ingredients (Fresh Breath) water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide
Inactive ingredients (Multi-Action) water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, sodium saccharin, mica, titanium dioxide, 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 Gentle Whitening potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 COCAMIDOPROPYL BETAINE TITANIUM DIOXIDE XANTHAN GUM SACCHARIN SODIUM SODIUM HYDROXIDE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION alpine breeze SENSODYNE PRONAMEL Daily Protection potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 COCAMIDOPROPYL BETAINE XANTHAN GUM SACCHARIN SODIUM TITANIUM DIOXIDE SODIUM HYDROXIDE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Mint Essence SENSODYNE PRONAMEL Fresh Breath potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 COCAMIDOPROPYL BETAINE XANTHAN GUM SACCHARIN SODIUM TITANIUM DIOXIDE SODIUM HYDROXIDE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION fresh wave SENSODYNE PRONAMEL Multi Action potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN COCAMIDOPROPYL BETAINE XANTHAN GUM SACCHARIN SODIUM MICA TITANIUM DIOXIDE SODIUM HYDROXIDE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Cleansing Mint
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 0135-0484-01 SENSODYNE PRONAMEL TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION Alpine Breeze GENTLE WHITENING Specialist Enamel Protection Rebuilds, Restores, Refreshes NET WT 4.0 OZ (113g) ALWAYS FOLLOW THE LABEL SENSODYNE PRONAMEL Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth. ACID ATTACKS ENAMEL WEAKENING THE ENAMEL STRUCTURE PRONAMEL REBUILDS & RESTORES ENAMEL FOR STRONG HEALTHY TEETH Healthy white teeth start with strong enamel. Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel. With twice-daily brushing, Pronamel helps to: Rebuild enamel strength for strong, healthy teeth Protect against the effects of dietary acids Relieve sensitive teeth Freshen breath Protect against cavities Recycle Carton, Tube and Cap† Save Water Turn off tap while brushing †Recycling facilities for this product may not exist in your area Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2021 GSK group of companies or its licensor. 62000000068970 Front Carton Sensodyne Gentle Whitening 6.5 OZ(184 g)
Principal Display Panel NDC 0135-0460-01 SENSODYNE PRONAMEL TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION Mint Essence DAILY PROTECTION Specialist Enamel Protection Rebuilds, Restores, Refreshes NET WT 4.0 OZ (113 g) ALWAYS FOLLOW THE LABEL SENSODYNE PRONAMEL Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth. ACID ATTACKS ENAMEL WEAKENING THE ENAMEL STRUCTURE PRONAMEL REBUILDS & RESTORES ENAMEL FOR STRONG HEALTHY TEETH Healthy white teeth start with strong enamel. Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel. With twice-daily brushing, Pronamel helps to: Rebuild enamel strength for strong, healthy teeth Protect against the effects of dietary acids Relieve sensitive teeth Freshen breath Protect against cavities Recycle Carton, Tube and Cap† Save Water Turn off tap while brushing †Recycling facilities for this product may not exist in your area Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2021 GSK group of companies or its licensor. 62000000068992 Front Carton Sensodyne Daily Protection 4.0 OZ(113 g)
Principal Display Panel NDC 0135-0520-01 SENSODYNE PRONAMEL TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION Fresh Wave FRESH BREATH Specialist Enamel Protection Rebuilds, Restores, Refreshes NET WT 4.0 OZ (113 g) ALWAYS FOLLOW THE LABEL SENSODYNE PRONAMEL Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth. ACID ATTACKS ENAMEL WEAKENING THE ENAMEL STRUCTURE PRONAMEL REBUILDS & RESTORES ENAMEL FOR STRONG HEALTHY TEETH Healthy white teeth start with strong enamel. Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel. With twice-daily brushing, Pronamel helps to: Rebuild enamel strength for strong, healthy teeth Protect against the effects of dietary acids Relieve sensitive teeth Freshen breath Protect against cavities Recycle Carton, Tube and Cap† Save Water Turn off tap while brushing †Recycling facilities for this product may not exist in your area Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2021 GSK group of companies or its licensor. 62000000068910 Front Carton Sensodyne Fresh Breath 4.0 OZ(113 g)
Principal Display Panel NDC 0135-0568-04 SENSODYNE PRONAMEL TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION Cleansing Mint MULTI-ACTION Specialist Enamel Protection Rebuilds, Restores, Refreshes NET WT 4.0 OZ (113 g) ALWAYS FOLLOW THE LABEL SENSODYNE PRONAMEL Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth. ACID ATTACKS ENAMEL WEAKENING THE ENAMEL STRUCTURE PRONAMEL REBUILDS & RESTORES ENAMEL FOR STRONG HEALTHY TEETH Healthy white teeth start with strong enamel. Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel. With twice-daily brushing, Pronamel helps to: Rebuild enamel strength for strong, healthy teeth Protect against the effects of dietary acids Relieve sensitive teeth Freshen breath Protect against cavities Recycle Carton, Tube and Cap† Save Water Turn off tap while brushing Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2021 GSK group of companies or its licensor. 62000000069352 Front Carton Sensodyne Multi-Action 4.0 OZ(113 g)
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information (Gentle Whitening, Daily Protection, Fresh Breath, Multi-Action) 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