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Product NDC Code | 51824-068 | ||||||||||||||||
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Drug Name | Freshmint anticavity fluoride |
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Type | Brand | ||||||||||||||||
Active Ingredients |
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Route | DENTAL | ||||||||||||||||
Dosage Form | GEL, DENTIFRICE | ||||||||||||||||
RxCUI drug identifier | 245598 | ||||||||||||||||
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.Sodium Fluoride - 0.22% (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.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 physician. do not swallow instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing use a pea-sized amount) supervise children as necessary until capable of using without supervision Children under 2 years: Ask a dentist or doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Treated Water, Sorbitol, Carbomer, Sodium Lauryl Sulfate, Flavor, PEG-32, Sodium Saccharin, Silica, Cellulose Gum, Sodium Hydroxide, Disodium EDTA
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.aids in the prevention of dental cavities
Purpose
Information about the drug product’s indications for use.Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Freshmint Anticavity Fluoride Sodium Fluoride Sodium Fluoride Fluoride Ion Water Sorbitol CARBOMER HOMOPOLYMER TYPE C Sodium Lauryl Sulfate POLYETHYLENE GLYCOL 1600 Saccharin Sodium Silicon Dioxide Carboxymethylcellulose Sodium SODIUM HYDROXIDE EDETATE DISODIUM ANHYDROUS Mint
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.Clear Gel Toothpaste
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. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right 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 . If more than used for brushing is accidentally swallowed, get 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