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Product NDC Code | 72805-150 | ||||
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Drug Name | Luster premium white power white pro |
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Type | Brand | ||||
Active Ingredients |
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Route | DENTAL | ||||
Dosage Form | PASTE | ||||
RxCUI drug identifier | 1546238 | ||||
Application Number | part355 | ||||
Labeler Name | French Transit, Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Sodium Monofluorophosphate 0.88% (w/w)
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 6 years of age and older Brush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by a dentist or doctor. Children 6 to 12 years Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years Do not use unless directed by a dentist or physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Vegetable Glycerin, Calcium Pyrophosphate, Zea Mays (Corn) Starch, Propylene Glycol, PEG-12, Water, Hydrogen Peroxide, Sodium Lauroyl, Sarcosinate, Flavor, Cellulose Gum, Carbomer, Sodium Saccharin, Butylated Hydroxytoluene
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.Use Helps protect against cavities.
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Luster Premium White Power White Pro Sodium Monofluorophosphate Sodium Monofluorophosphate FLUORIDE ION Water Calcium Pyrophosphate STARCH, CORN Propylene Glycol POLYETHYLENE GLYCOL 600 Hydrogen Peroxide Sodium Lauroyl Sarcosinate CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) SACCHARIN SODIUM Butylated Hydroxytoluene Luster Premium White Power White Pro Sodium Monofluorophosphate Sodium Monofluorophosphate FLUORIDE ION Water Calcium Pyrophosphate STARCH, CORN Propylene Glycol POLYETHYLENE GLYCOL 600 Hydrogen Peroxide Sodium Lauroyl Sarcosinate CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) SACCHARIN SODIUM Butylated Hydroxytoluene
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 - 113 g Tube Box NEW! LUSTER PREMIUM WHITE ® POWER WHITE PRO DEEP STAIN ERASER ® ANTICAVITY FLUORIDE TOOTHPASTE PROVEN EFFECTIVE TO REMOVE UP TO 95% OF SURFACE STAINS IN 5 DAYS † DAILY CARE + WHITENING ENAMEL SAFE GENTLE & SULFATE-FREE MINT NET WT. 4 OZ (113 g) SATISFACTION GUARANTEED ‡ PRINCIPAL DISPLAY PANEL - 113 g Tube Box
PRINCIPAL DISPLAY PANEL - 28 g Tube Label LUSTER PREMIUM WHITE ® POWER WHITE PRO™ DEEP STAIN ERASER ® ANTICAVITY FLUORIDE TOOTHPASTE PROVEN EFFECTIVE TO REMOVE UP TO 95% OF SURFACE STAINS IN 5 DAYS † DAILY CARE + WHITENING ENAMEL SAFE ZERO SENSITIVITY MINT NET WT. 1 OZ (28 g) SATISFACTION GUARANTEED PRINCIPAL DISPLAY PANEL - 28 g Tube Label
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
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 6 years of age. 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? 1-800-823-5272
Storage and handling
Information about safe storage and handling of the drug product.Other information Store between 10-27 degrees Celsius (50-80 degrees Fahrenheit)
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 Keep out of reach of children under 6 years of age. 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