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| Product NDC Code | 10056-530 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Glister multi-action fluoride |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PASTE, DENTIFRICE | ||||||
| RxCUI drug identifier | 1099038 | ||||||
| Application Number | M021 | ||||||
| Labeler Name | Access Business Group, 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 Ingredients Sodium fluoride 0.21%
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 Do not swallow Adults and children 2 years and over: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or doctor Instruct children under 6 years in good rinsing habits (to reduce swallowing) Supervise children as necessary until capable of using without supervision Children under 2 years, ask a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Sorbitol, Hydrated Silica, Glycerin, Propylene Glycol, Sodium Lauryl Sulfate, Xylitol, Cellulose Gum, PEG-8, Flavor, Titanium Dioxide, Xanthan Gum, Sodium Saccharin, Methylparaben, Propylparaben, Blue No. 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
Spl product data elements
Usually a list of ingredients in a drug product.Glister Multi-Action Fluoride SODIUM FLUORIDE WATER SORBITOL HYDRATED SILICA GLYCERIN PROPYLENE GLYCOL SODIUM LAURYL SULFATE XYLITOL CARBOXYMETHYLCELLULOSE SODIUM POLYETHYLENE GLYCOL TITANIUM DIOXIDE XANTHAN GUM SACCHARIN SODIUM METHYLPARABEN PROPYLPARABEN FD&C BLUE NO. 1 SODIUM FLUORIDE FLUORIDE ION
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.Dist. by Access Business Group International LLC, Ada, MI 49355 Glister multi-action fluoride toothpaste Multiple action whitens teeth removes plaque fights cavities safely cleans freshens breath promotes remineralization MADE IN U.S.A.
Package Labeling: 10056-530-06 191 Label06
Package Labeling: 10056-530-65 65 Label65
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.With regular brushing, glister multi-action fluoride toothpaste helps remove plaque. This product contains SYLODENT polishing agent which safely cleans and helps eliminate stains to whiten teeth. To enhance your overall oral health, use the complete glister oral care system Trademark is used by Access under license.
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
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 If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children under 6 years of age
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