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Product NDC Code | 55910-820 | ||||
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Drug Name | Rexall restore and defend sensitive whitening |
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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 | Old East Main CO. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Stannous Fluoride 0.454% (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 • Adult and children 12 years & 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 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, hydrated silica, treated water, PEG-8, PEG-32, sodium lauryl sulphate, tetrasodium pyrophosphate, flavor, trisodium phosphate, titanium dioxide, cocamidopropyl betaine, sodium saccharin, xanthan gum, polyacrylic acid, benzyl alcohol
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.Rexall Restore and Defend Sensitive Whitening Stannous Fluoride STANNOUS FLUORIDE FLUORIDE ION GLYCERIN SILICON DIOXIDE WATER POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 1600 SODIUM LAURYL SULFATE SODIUM PYROPHOSPHATE SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE TITANIUM DIOXIDE COCAMIDOPROPYL BETAINE SACCHARIN SODIUM XANTHAN GUM CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) BENZYL ALCOHOL
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.Packaging IMAGE
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
Since 1903 TOOTHPASTE WITH FLUORIDE • For sensitive teeth and cavity protection • Great for everyday use Brushing twice a day with Rexall ™ Restore & Defend Sensitive Toothpaste helps repair sensitive teeth and protect against painful sensitivity. • Provides daily relief & protection for sensitive teeth* • Contains fluoride for cavity protection • Removes stains for whiter teeth • Freshens breath 100% Satisfaction Guaranteed! (888) 309-9030 *With brushing twice daily DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 PRODUCT OF INDIA
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 under 12 years of age. If more than amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other information Products containing stannous fluoride may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. Store at room temperature 68-77°F (20-25°C)
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 under 12 years of age. If more than amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.
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