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| Product NDC Code | 83062-083 | ||||
|---|---|---|---|---|---|
| Drug Name | Sparklefresh fluoride |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 545626 | ||||
| Application Number | M022 | ||||
| Labeler Name | IIMED MEDICAL MEXICANA S DE RL DE CV | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium Monofluorophosphate 0.76%
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 yrs. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist or physician -instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) -supervise children as necessary until capable of using without supervision -children under 2 years of age: consult a dentist or physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients calcium carbonate, treated water, sorbitol, precipitated silica, sodium lauryl sulfate, flavor, sodium carboxymethyl cellulose, sodium silicate, tetrasodium pyrophosphate, sodium saccharin,methylparaben, titanium dioxide, polyethylene glycol 400, 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 Aids in the prevention of dental 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.Sparklefresh Fluoride Sodium monofluorophosphate SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION WATER CARBOXYMETHYLCELLULOSE SODIUM SORBITOL SODIUM LAURYL SULFATE POLYETHYLENE GLYCOL 400 SODIUM PYROPHOSPHATE TITANIUM DIOXIDE PROPYLPARABEN CALCIUM CARBONATE SODIUM SILICATE METHYLPARABEN SACCHARIN SODIUM SILICON DIOXIDE
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.Label Entire Label
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 If you accidentally swallow more than used for brushing, seek medical help or contact a Poison 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 if If you accidentally swallow more than used for brushing, seek medical help or contact a Poison 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