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| Product NDC Code | 59883-718 | ||||
|---|---|---|---|---|---|
| Drug Name | Kids kare |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL, ORAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 416783 | ||||
| Application Number | M021 | ||||
| Labeler Name | DEN-MAT HOLDINGS, 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 0.24% (0.14% 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 of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor. Children under 2 years of age: Consult a dentist or doctor. Do not swallow. To minimize swallowing, use a pea-sized amount in children under 6. Instruct children under 6 years of age in good brushing and rinsing habits. Supervise children as necessary until capable of using without supervision.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Sorbitol, Water, Hydrated Silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propylparaben, 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 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.Kids Kare Sodium Fluoride METHYLPARABEN SORBITOL PROPYLPARABEN POLYETHYLENE GLYCOL 1450 HYDRATED SILICA SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE BERRY POLYETHYLENE GLYCOL 300 SODIUM FLUORIDE FLUORIDE ION WATER FD&C BLUE NO. 1 SACCHARIN SODIUM SACCHARIN
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 kids kare™ Preventative Treatment 0.24% Sodium Fluoride Toothpaste Berry Flavor IMPORTANT: Read directions carefully Net Wt. 4 oz. (113.4 g) Kids_Kare_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 under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Do not use if the foil seal under the cap is torn, cut or missing.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-800-752-2564
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
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