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Freshmax fluoride minty flavor - Medication Information

Product NDC Code 52862-501
Drug Name

Freshmax fluoride minty flavor

Type Brand
Active Ingredients
Sodium monofluorophosphate 76 mg/g
Route DENTAL
Dosage Form PASTE
RxCUI drug identifier 545626
Application Number M021
Labeler Name International Wholesale Inc
Packages
Package NDC Code Description
52862-501-00 1 tube in 1 box (52862-501-00) / 181 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Sodium Monofluorophosphate 0.76% (Available fluoride content:1000ppm) Purpose Anticavity

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 Brush teeth thoroughly, preferable after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age to use a pea size amount. Supervise child’s brushing and rinsing (to minimize swallowing.) Consult a dentist or physician. Adults and children 2 years of age or older: Children under 6 years: Children under 2 years of age:

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Water, Sorbitol, Polyethylene Glycol 400, Sodium Carboxymethylcellulose, Silica, Gypsum Powder, Sodium Saccharin, Sodium Lauryl Alcohol, Flavor, Methyl Paraben, Propylparaben, Color: Bright Blue.

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 Regular brushing with Fluoride toothpaste helps protect teeth and roots against 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.
FreshMax Fluoride Minty Flavor SODIUM MONOFLUOROPHOSPHATE WATER SORBITOL POLYETHYLENE GLYCOL 400 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM SILICON DIOXIDE METHYL SALICYLATE METHYLPARABEN PROPYLPARABEN SODIUM MONOFLUOROPHOSPHATE 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.
Package Labeling: Label2

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.
Drug Facts Other Information: Lot No. & Expiration Date: See box or crimp of tube.

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. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

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 Keep out of reach of children under 6 years of age. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

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