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| Product NDC Code | 63517-070 | ||||
|---|---|---|---|---|---|
| Drug Name | Cardinal health |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 416783 | ||||
| Application Number | M021 | ||||
| Labeler Name | Cardinal Health 200, 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% (0.15% 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 yrs. and older: brush teeth thoroughly after meals or at least twice a day or directed by a dentist or physician. Instruct children under 6yrs of age in good brushing and rinsing habits (to minimize swallowing). Use a pea-size amount for children under 6. Supervise children as necessary until capable of using without supervision. Children under 2 yrs. of age: Consult a dentist or physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Sorbitol, Hydrated Silica, Water, Glycerin, PEG 12, Sodium Lauryl Sulfate, Titanium Dioxide, Cellulose Gum, Flavor, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin, 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 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.Cardinal Health Sodium Fluoride MINT POLYETHYLENE GLYCOL 600 SODIUM FLUORIDE FLUORIDE ION HYDRATED SILICA SODIUM LAURYL SULFATE TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM SODIUM BENZOATE SACCHARIN SODIUM FD&C BLUE NO. 1 SORBITOL GLYCERIN SODIUM PHOSPHATE, DIBASIC, DIHYDRATE WATER
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 anticavity toothpaste with fluoride ADA Accepted American Dental Association Cardinal Health™ net wt 0.85 oz (24 g) NDC 63517-0702-1 REF OC-TPASTE Distributed by: Cardinal Health, Waukegan, IL USA 60085 Rev.A 2020-11 • OC-TPASTE (F) © 2020 Cardinal Health. All Rights Reserved. cardinalhealth.com/symbolsglossary Cardinal_Toothpaste_image.jpg
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 the reach of children under 6yrs. of age. If you accidentally swallow more than used for brushing, seek medical 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
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