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| Product NDC Code | 67239-0226 | ||||
|---|---|---|---|---|---|
| Drug Name | Sodium fluoride |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 891775 | ||||
| Application Number | part355 | ||||
| Labeler Name | Safco Dental Supply 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 - 0.243% (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 6-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 a physician. Children 2 to 6 years Use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing) Children under 2 years Ask a dentist or a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other ingredients: Sorbitol, Silica, Treated Water, Poly Ethylene Glycol 1500, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Cellulose gum and/or Carrageenan, Trisodium Orthophosphate, Sodium Saccharin, Tetra Sodium Pyrophosphate, Glycerin, Color: FD&C Blue #1 Package date and batch number on crimp.
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: Helps protect against cavities
Purpose
Information about the drug product’s indications for use.Purpose: Anti-cavity
Spl product data elements
Usually a list of ingredients in a drug product.Sodium Fluoride SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SORBITOL SILICON DIOXIDE WATER GLYCERIN POLYETHYLENE GLYCOL 1500 SODIUM LAURYL SULFATE TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN XANTHAN GUM BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE SACCHARIN SODIUM SODIUM PYROPHOSPHATE SODIUM BENZOATE METHYLPARABEN PROPYLPARABEN BENZYL ALCOHOL TRICLOSAN PROPYLENE GLYCOL SODIUM HYDROXIDE FD&C BLUE NO. 1
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 – 24 g Box Label Quantum Fresh FLUORIDE TOOTHPASTE Quantum a safco company 800-328-8213 www.QuantumLabs.com Fluoride Toothpaste Reorder # 826-0001 Net Wt. 0.85 oz (24 g) Expiration Date: 2 years from date packed. NDC 67239-0226-0 Made in India Principal Display Panel – 24 g Box 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 THE REACH OF CHILDREN UNDER 6 YEARS OF AGE. If you accidentally 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.Warning: KEEP OUT OF THE REACH OF CHILDREN UNDER 6 YEARS OF AGE. If you accidentally 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