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Plaque hd anticavity fresh mint flavor professional plaque-identifying - Medication Information

Product NDC Code 57660-000
Drug Name

Plaque hd anticavity fresh mint flavor professional plaque-identifying

Type Brand
Active Ingredients
Sodium fluoride .14 g/100g
Route DENTAL
Dosage Form PASTE, DENTIFRICE
RxCUI drug identifier 416783
Application Number M021
Labeler Name TJA Health LLC
Packages
Package NDC Code Description
57660-000-01 1 tube in 1 package (57660-000-01) / 116 g in 1 tube
57660-000-02 1 tube in 1 package (57660-000-02) / 21 g in 1 tube
57660-000-03 1 tube in 1 package (57660-000-03) / 116 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Sodium Fluoride 0.24% (0.14% 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 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 year of age: Consult a dentist or doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, sorbitol, hydrated silica, glycerin, tetrasodium pyrophsphate, sodium bicarbonate, PVP, sodium benzoate, sodium lauryl sulfate, flavor, carbomer, cellulose gum, annatto extract, xylitol, sodium saccharin, disodium EDTA, 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.
Use 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.
PLAQUE HD ANTICAVITY FRESH MINT FLAVOR Professional Plaque-Identifying SODIUM FLUORIDE WATER SORBITOL HYDRATED SILICA GLYCERIN SODIUM PYROPHOSPHATE SODIUM BICARBONATE POVIDONE, UNSPECIFIED SODIUM BENZOATE SODIUM LAURYL SULFATE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANNATTO XYLITOL SACCHARIN SODIUM EDETATE DISODIUM FD&C BLUE NO. 1 SODIUM FLUORIDE FLUORIDE ION Fresh Mint Flavor

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: 57660-000-01 Mint Label Mint Label2 Representative Labeling (57660-000-03) Mint Tube Mint Box

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 Store at room temperature

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. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? call toll-free-1-(800) 737-4860

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. If more than used for brushing is accidentally swallowed, 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