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| Product NDC Code | 83592-800 | ||||
|---|---|---|---|---|---|
| Drug Name | Fraiche stannous fluoride rinse, spearmint flavor |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 583459 | ||||
| Application Number | M021 | ||||
| Labeler Name | True Marker Pharmaceuticals, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (s) Stannous fluoride, 0.63%
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 use before mixing with water. • Adults and children 6 years of age and older: • Use once a day after brushing your teeth with a toothpaste. • Open the bottle by twisting the cap counter clockwise. • Pour to the first line (0.159 oz) on cup. Add water to second line (1fl oz.) on cup. • Mix using bristle end of toothbrush. • Vigorously swish rinse between your teeth for 1 min. and then spit out. • Do not swallow the rinse. • Do not eat or drink for 30 min. after rinsing. • Instruct children under 12 in good rinsing habits to minimize swallowing.Supervise children as necessary until capable of using without supervision. • Children under 6 : Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Edetic Acid, Flavor, Glycerin, Saccharin Sodium, Xylitol
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 decay helps prevent gingivitis helps interfere with harmful effects of plaque associated with gingivitis.
Purpose
Information about the drug product’s indications for use.Purpose Anticavity/Antigingivitis
Spl product data elements
Usually a list of ingredients in a drug product.Fraiche Stannous Fluoride Rinse, Spearmint Flavor Stannous Fluoride EDETIC ACID GLYCERIN SACCHARIN SODIUM XYLITOL STANNOUS 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.Product label image description image description
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.Other information Store at room temperature 59-86˚F (15-30˚C) This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
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 rinsing is swallowed, get medical help or contact a Poison Control Center right away. Do not swallow.
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