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| Product NDC Code | 74355-322 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Unpaste |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | DENTAL | ||||||||
| Dosage Form | TABLET, CHEWABLE | ||||||||
| Application Number | part355 | ||||||||
| Labeler Name | Avespan LLC | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Sodium Fluoride 0.62mg (28 mg flouride 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 Adults and children 6 years of age and older; chew one tablet briefly and brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Do not swallow the tablet. Supervise children under 6 years of age for brushing and rinsing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Microcrystalline Cellulose, Sodium bicarbonate (Baking Soda), Silica, Sodium Lauryl Glutamate, Magnesium Stearate, Natural Mint Flavor, Menthol, Xanthan Gum, Stevia (Stevioside), Citric Acid
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 Anti-cavity
Spl product data elements
Usually a list of ingredients in a drug product.Unpaste Zero waste fluoride mint tooth tabs STEVIA LEAF CITRIC ACID MONOHYDRATE SODIUM BICARBONATE SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE MINT MENTHOL, (+)- XANTHAN GUM SODIUM LAUROYL GLUTAMATE MAGNESIUM STEARATE SODIUM FLUORIDE FLUORIDE ION NONE
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 125 tabs, NDC: 74355-322-02 68984-112-01
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.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product, if irritation or sensitivity occurs discontinue use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 25-30°C (68-77°F). Protect from excessive moisture.
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 When using this product, if irritation or sensitivity occurs discontinue use. Keep out of the reach of children. If more than used for brushing is accidentally swallowed, get 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