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| Product NDC Code | 59883-004 | ||||
|---|---|---|---|---|---|
| Drug Name | Fluoridex |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M021 | ||||
| Labeler Name | DEN-MAT HOLDINGS, 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 Stannous Fluoride 0.63% Rinse Concentrate
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 6 years of age and older: Do not use before mixing with water Use once a day after brushing your teeth with a toothpaste Separate provided graduated cup from the mixing cap Fill graduated cup to 1/8oz. fill line with Fluoridex Daily Renewal Oral Rinse Concentrate Add warm water to 1 oz. fill line Place the mixing cap onto the filled cap until it snaps closed Shake thoroughly then remove mixing cap Use immediately after preparing the rinse Vigorously swish with half of the prepared solution between your teeth for 1 minute and then spit out Do not swallow the rinse Repeat the procedure with the remaining half of the prepared solution Do not eat or drink for 30 minutes after rinising Instruct children under 12 years of age in good rinsing habits (to minimize swallowing) Supervise children as necessary until capable of using without supervision Children under 6 years of age Consult a dentist or doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Glycerin, Hydrogenated Starch Hydrolysate, Flavor
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.Fluoridex Stannous Fluoride Rinse STANNOUS FLUORIDE FLUORIDE ION GLYCERIN HYDROGENATED STARCH HYDROLYSATE
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.NDC 59883-004-01 FLUORIDEX DAILY RENEWAL Prescription-Strength Dental Decay Prevention Oral Rinse Concentrate CLEAN MINT 0.63% Stannous Fluoride 8.4 fl. oz. (248 ml) Rx Only Fluoridex_Rinse_image.jpg
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.Warnings Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information This product may produce surface staining of the teeth Adequatetoothbrushing may prevent these stains which are harmful or permanent and may be removed by your dentist Store at controlled room temperature 15º - 30ºC (59º - 86º F) See package insert for additional information For your protection, do not use if tamper seal on box is broken or missing
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call: 1-800-752-2564
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.Do not swallow the rinse
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