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Product NDC Code | 56062-413 | ||||
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Drug Name | Sensitive extra whitening |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | PASTE, DENTIFRICE | ||||
RxCUI drug identifier | 1038929 | ||||
Application Number | M022 | ||||
Labeler Name | Publix Super Market | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Potassium nitrate 5% Sodium fluoride 0.24% (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.adults and children 12 years pf age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush * brush teeth thoroughly for at least one 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.water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioixde, 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.builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact * acids in the prevention of dental cavities
Purpose
Information about the drug product’s indications for use.Antihypersensitivity Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Sensitive Extra Whitening Sodium Fluoride SORBITOL SODIUM HYDROXIDE POLYETHYLENE GLYCOL 400 HYDRATED SILICA WATER GLYCERIN SODIUM METHYL COCOYL TAURATE SODIUM FLUORIDE FLUORIDE ION COCAMIDOPROPYL BETAINE TITANIUM DIOXIDE XANTHAN GUM SODIUM TRIPOLYPHOSPHATE ANHYDROUS POTASSIUM NITRATE NITRATE 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.Publix Sensitive
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 Center right away.
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.When using this product, if irritation occurs discontinue. Stop use and ask a dentist if * the problem persists or worsen. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. * pain/sensitivity still persists after 4 weeks of use.
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