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Glister multi-action fluoride - Medication Information

Product NDC Code 10056-530
Drug Name

Glister multi-action fluoride

Type Brand
Active Ingredients
Sodium fluoride 2.1 mg/g
Route TOPICAL
Dosage Form PASTE, DENTIFRICE
RxCUI drug identifier 1099038
Application Number M021
Labeler Name Access Business Group, LLC
Packages
Package NDC Code Description
10056-530-06 1 tube in 1 box (10056-530-06) / 191 g in 1 tube
10056-530-65 1 tube in 1 box (10056-530-65) / 65 g in 1 tube
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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