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Product NDC Code | 66923-123 | ||||
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Drug Name | Rembrandt deeply white plus peroxide |
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Type | Brand | ||||
Active Ingredients |
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Route | DENTAL | ||||
Dosage Form | PASTE, DENTIFRICE | ||||
Application Number | M021 | ||||
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 Monofluorophosphate (0.884%)
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), preferable after each meal or at least twice 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 calcium pyrophosphate, water, glycerin, PEG-8, colloidal silicon dioxide, hydrogen peroxide, flavor, sodium lauryl sulfate, sodium saccharin, cellulose gum, xanthan gum, citric acid, sodium citrate, sucralose, trisodium ethylenediamine, PVP
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 Deeply White Plus Peroxide sodium monofluorophosphate SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION CALCIUM PYROPHOSPHATE WATER GLYCERIN POLYETHYLENE GLYCOL 400 SILICON DIOXIDE HYDROGEN PEROXIDE SODIUM LAURYL SULFATE SACCHARIN SODIUM CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED XANTHAN GUM CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE POVIDONE, UNSPECIFIED
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.Package/Label Principal Display Panel D DEEPLY WHITE® + Peroxide WHITER TEETH IN 3 DAYS REMBRANDT® ANTICAVITY FLUORIDE TOOTHPASTE WITH PEROXIDE STRENGTHENS & RESTORES ENAMEL Peppermint NET WT 3.5 OZ (99.2 g) rembrandt-tym
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).
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 amount used for brushing is accidentally swallowed, seek 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