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Product NDC Code | 51824-046 | ||||||
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Drug Name | Freshmint premium anticavity gel |
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Type | Brand | ||||||
Active Ingredients |
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Route | DENTAL | ||||||
Dosage Form | PASTE, DENTIFRICE | ||||||
RxCUI drug identifier | 891775 | ||||||
Application Number | M021 | ||||||
Labeler Name | New World Imports, Inc | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.OTC Active Ingredient Sodium Fluoride - 0.243% (0.15 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 and children 2 years & older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. To minimize swallowing use a pea-sized amount in children under 6 years of age. Supervise children's brushing until good habits are established. Children under 2 years: Ask a dentist
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Sorbitol, Silica, Treated Water, Polyethylene Glycol 1500, Sodium Lauryl Sulfate, Glycerin, Flavor, Cellulose Gum, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, Methylparaben, Tetrasodium Pyrophosphate, Propylparaben, FD&C Blue # 1
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.Uses Helps protect teeth and roots against cavities.
Purpose
Information about the drug product’s indications for use.OTC Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Freshmint Premium Anticavity Gel Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SORBITOL SILICON DIOXIDE WATER POLYETHYLENE GLYCOL 1500 SODIUM LAURYL SULFATE GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM SODIUM BENZOATE SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE METHYLPARABEN SODIUM PYROPHOSPHATE PROPYLPARABEN FD&C BLUE NO. 1 SACCHARIN SODIUM Aqua Blue
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.ADA Tube
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 you accidentally swallow more than used for brushing, seek professional 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 reach of children under 6 years of age. if you accidentally swallow more than used for brushing, seek professional 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