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Product NDC Code | 0135-0580 | ||||||
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Drug Name | Sensodyne pronamel gentle whitening advanced |
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Type | Brand | ||||||
Active Ingredients |
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Route | DENTAL | ||||||
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, hydrated silica, sorbitol, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, 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.Purposes Antihypersensitivity Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Sensodyne Pronamel Gentle Whitening Advanced potassium nitrate and sodium fluoride POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION WATER HYDRATED SILICA SORBITOL GLYCERIN POLYETHYLENE GLYCOL 400 COCAMIDOPROPYL BETAINE XANTHAN GUM TITANIUM DIOXIDE SACCHARIN SODIUM SODIUM HYDROXIDE
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 4 PACK SENSODYNE PRONAMEL TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION Specialist Enamel Protection Rebuilds, Restores, Refreshes Alpine Breeze GENTLE WHITENING ADVANCED POWERFUL WHITENING*, GENTLE ON ENAMEL 4 TUBES OF 6.5 OZ (184 g) EACH – TOTAL NET WT 26 OZ (736 g) Sensodyne Pronamel GW Adv 4 pk
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.Generic Section SENSODYNE PRONAMEL 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. ACID ATTACKS ENAMEL WEAKENING THE ENAMEL STRUCTURE PRONAMEL REBUUILDS & RESTORES ENAMEL FOR STRONG HEALTHY TEETH Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide * removes stains ALWAYS FOLLOW THE LABEL CARTON RECYCLE TUBE RECYCLE CAP† CHECK LOCALLY † Recycling facilities for the cap may not exist in your area Save Water Turn off tap while brushing Recyclable Packaging Recyclable Carton Recyclable Tube & Cap† SPECIALIST ENAMEL PROTECTION The acids in your diet can damage tooth enamel, leading to dull, yellow teeth. Wine Acids Fruit Acids Soda Acids Pronamel strengthens acid weakened enamel and protects teeth from these acids, keeping teeth strong, healthy and white. SENSODYNE PRONAMEL POWERFUL WHITENING* GENTLE ON ENAMEL #1 DENTIST RECOMMENDED ENAMEL BRAND
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • do not store above 25°C (77°F)
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.
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