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| Product NDC Code | 57660-001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Plaque hd anticavity berry bubble gum flavor professional plaque-identifying |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | DENTAL | ||||||
| Dosage Form | PASTE, DENTIFRICE | ||||||
| RxCUI drug identifier | 416783 | ||||||
| Application Number | M021 | ||||||
| Labeler Name | TJA Health 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 0.24% (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 BERRY BUBBLE GUM 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 Berry Bubble Gum 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 (57660-001-01) Box Label Box Label2
Representative Labeling (57660-001-02) Box Tube
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