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| Product NDC Code | 65517-2000 | ||||||||||||||||||
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| Drug Name | Sodium fluoride |
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| Type | Brand | ||||||||||||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||||||||||||
| Dosage Form | CREAM | ||||||||||||||||||
| RxCUI drug identifier | 245598 | ||||||||||||||||||
| Application Number | M022 | ||||||||||||||||||
| Labeler Name | DUKAL 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 Sodium fluoride 0.22%
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: and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Children under 6 years: To minimize swallowing use a pea sized amount and supervise brushing until good habits are established. Children under 2 years: Ask a doctor or physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients calcium carbonate,water,sorbitol, sodium lauryl sulfate, silica, carboxymethyl cellulose, flavor, potassium nitrate, sodium benzoate, sodium saccharin, menthol
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 Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Sodium fluoride Toothpaste CALCIUM CARBONATE WATER SORBITOL SODIUM LAURYL SULFATE SILICON DIOXIDE CARBOXYMETHYLCELLULOSE POTASSIUM NITRATE SODIUM BENZOATE SACCHARIN SODIUM MENTHOL SODIUM FLUORIDE FLUORIDE ION White
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 - DawnMist Fluoride Toothpaste 0.6 OZ Tube Label DawnMist ® NDC: 65517-2000-0 ORAL CARE Fluoride Toothpaste CAVITY FIGHTING FORMULA FRESH MINT FLAVOR 0.6 OZ. (17 g) Principal Display Panel - DawnMist Fluoride Toothpaste 0.6 OZ 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.Expiration date Expiration date & batch No. on crimp of 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 Keep out of reach of children under six years of age. If you accidently swallow more than used for brushing seek professional assistance 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 Section Warnings Keep out of reach of children Keep out of reach of children under six years of age. If you accidently swallow more than used for brushing seek professional assistance 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