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Product NDC Code | 53567-0030 | ||||
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Drug Name | Supersmile original mint |
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Type | Brand | ||||
Active Ingredients |
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Route | DENTAL | ||||
Dosage Form | PASTE, DENTIFRICE | ||||
RxCUI drug identifier | 2695772 | ||||
Application Number | M021 | ||||
Labeler Name | Robell Research, Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Sodium Monoflurophosphate 0.79% (0.14% w/v Fluoride Ion) .................... Anticavity
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.Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruc children under 6 years of age in good brushing and rinsing habots (to minimize swallowing). Supervise children as necessary until capable of using wihtout supervision. Children under 2 years of age: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water, Sorbitol, Dicalcium Phosphate, Calcium Carbonate, Sodium Bicarbonate, Titanium Dioxide, Cellulose Gum, Calprox®, Sodium Perborate, Corn Starch, Flavor, Magnesium Carbonate, Sodium Lauryl Sulfoacetate, 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.Place a pearl-sized drop of Whitening toothpaste on a dry toothbrush and brush in a circular motion for 2 minutes, 2x a day.
Purpose
Information about the drug product’s indications for use.Aids in the prevention of dental cavities
Spl product data elements
Usually a list of ingredients in a drug product.Supersmile Original Mint Sodium Monofluorophosphate SACCHARIN SODIUM STARCH, CORN CARBOXYMETHYLCELLULOSE SODIUM SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION CALCIUM PEROXIDE WATER SODIUM PERBORATE TETRAHYDRATE CALCIUM CARBONATE TITANIUM DIOXIDE DIBASIC CALCIUM PHOSPHATE DIHYDRATE MAGNESIUM CARBONATE SODIUM LAURYL SULFOACETATE SORBITOL SODIUM BICARBONATE White opaque
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.Supersmile Professional Whitening Toothpaste Original Mint
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 old. If you accedentally swallow more than used for brushing, get medical help or call a Posion control center rigth away.
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.Keep out of reach of children under 6 years old. If you accidentally swallow more than used for brushing, get medical help or call a Posion control center rigth 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