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| Product NDC Code | 66923-373 | ||||
|---|---|---|---|---|---|
| Drug Name | Rembrandt intense stain |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 891775 | ||||
| Application Number | part355 | ||||
| Labeler Name | Ranir LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium Fluoride (0.243%)
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 2 years of age and older: Brush teeth thoroughly (for at least 1 minute), preferably after each meal or at least 2 times a day, or as directed by a dentist or doctor. Children under 6 years of age: Use a pea-sized amount and instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor. Do not swallow.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Glycerin, Hydrated Silica, Water, Sorbitol, Tetrapotassium Pyrophosphate, Flavor, Titanium Dioxide, Sodium Lauroyl Sarcosinate, Cellulose Gum, Lauryl Glucoside, PVP, Sodium Sulfate, Cocamidopropyl Betaine, Xanthan Gum, Sodium Saccharin, Sucralose.
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 Aids in the prevention of dental 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.Rembrandt Intense Stain Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION GLYCERIN HYDRATED SILICA WATER SORBITOL POTASSIUM PYROPHOSPHATE TITANIUM DIOXIDE SODIUM LAUROYL SARCOSINATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM LAURYL GLUCOSIDE POVIDONE, UNSPECIFIED SODIUM SULFATE COCAMIDOPROPYL BETAINE XANTHAN GUM SACCHARIN SODIUM SUCRALOSE
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 I INTENSE STAIN® REMBRANDT WHITENING TOOTHPASTE WITH FLUORIDE Mint 25x MORE STAIN REMOVED IN 1 WEEK STRENGTHENS & RESTORES ENAMEL NET WT 3.5 OZ (99.2 g) rembrandt-intense-stain-carton
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.Directions: updated use instructions 7/2/2019
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 amount used for brushing is accidentally swallowed, seek 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 • Store at 20°-25°C (68°-77°F). • Do not use if inner foil is torn, cut or missing.
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? Email [email protected] , or call 800-548-3663. Distributed by Ranir, LLC, Grand Rapids, MI 49512 ©2018 Ranir, LLC 80102AB
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
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