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| Product NDC Code | 41250-530 | ||||
|---|---|---|---|---|---|
| Drug Name | Meijer restore and defend sensitive |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 416784 | ||||
| Application Number | M021 | ||||
| Labeler Name | Meijer Distribution Inc | ||||
| 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 ingredient Stannous Fluoride 0.454% (w/v 0.15% 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 one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. 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 glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, 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.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 Anticavity/Antihypersensitivity
Spl product data elements
Usually a list of ingredients in a drug product.Meijer Restore and Defend Sensitive Stannous fluoride GLYCERIN SACCHARIN SODIUM WATER TITANIUM DIOXIDE SODIUM TRIPOLYPHOSPHATE ANHYDROUS CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM COCAMIDOPROPYL BETAINE SODIUM LAURYL SULFATE HYDRATED SILICA STANNOUS 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.meijer™ WHITENING Restore & Defend Toothpaste For sensitive teeth and cavity protection Builds protective coating on sensitive areas of teeth NET WT 3.4 OZ (96.4 g) MeijerRestoreWhiten2821277R1
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.Drug Facts
DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com MADE IN USA
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.
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 If pain/sensitivity still persists after 4 weeks of use, please visit your dentist. 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