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Product NDC Code | 53247-131 | ||||||||||||||||
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Drug Name | Nature mint anticavity |
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Type | Brand | ||||||||||||||||
Active Ingredients |
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Route | DENTAL | ||||||||||||||||
Dosage Form | PASTE, DENTIFRICE | ||||||||||||||||
RxCUI drug identifier | 545626 | ||||||||||||||||
Application Number | M021 | ||||||||||||||||
Labeler Name | Bob Barker Company Inc. | ||||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Sodium Monofluorophosphate - 0.76% (0.1% W/V fluoride 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 & Children 6 years of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing). Children under 2 years: Ask a dentist or physician.
Adults & Children 6 years of age & older: | Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. |
Children 2 to 6 years: | Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing). |
Children under 2 years: | Ask a dentist or physician. |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Calcium Carbonate, Water, Glycerin, Silica, Sodium Lauryl Sulfate, Xanthan Gum, Flavor, Sodium Saccharin, Titanium Dioxide, Sodium Methylparaben, Sodium Propylparaben
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 toothpaste
Spl product data elements
Usually a list of ingredients in a drug product.Nature Mint Anticavity Sodium Monofluorophosphate Sodium Monofluorophosphate Fluoride Ion Calcium Carbonate Water Glycerin Silicon Dioxide Sodium Lauryl Sulfate Xanthan Gum Saccharin Sodium Titanium Dioxide Methylparaben Sodium Propylparaben Sodium
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 - 43 Gram Tube Label Nature Mint ® ANTICAVITY FLUORIDE TOOTHPASTE SODIUM MONOFLUOROPHOSPHATE - 0.76% FRESH MINT FLAVOR NET WT 1.5 OZ (43 GRAMS) PRINCIPAL DISPLAY PANEL - 43 Gram 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:
Dist. by Bob Barker Co. Inc. Fuquay-Varina, NC 27526
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 the 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 immediately.
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 the 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 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