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| Product NDC Code | 59883-821 | ||||
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| Drug Name | Pro-den rx |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 392038, 1101883 |
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| Application Number | part355 | ||||
| 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.OTC - ACTIVE INGREDIENT Description: A home care, self-applied topical fluoride treatment containing 1.1% Neutral Sodium Fluoride (5000 ppm F) for daily use to aid in the protection against dental caries in adults and pediatric patients. Neutral Sodium Fluoride 1.1% w/w (5000 ppm F). Inactive Ingredients: Diatomite, Flavor, Glycerin, Carboxymethyl Cellulose, Phosphoric Acid, Sodium Benzoate, Sodium Saccharin and Purified Water.
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.DOSAGE & ADMINISTRATION SECTION Dosage and Administration: Adults and Children over 6 years of age: Use in place of your regular toothpaste. Apply at bedtime or more often if your dentist recommends additional therapy based on the diagnosis. Cover brush head with ProDenRx 1.1% Neutral Sodium Fluoride Gel and brush around all tooth surfaces and gum line for at least 1 minute. Spit out gel. Adults: Wait 30 minutes before rinsing mouth. For children under age 12: Rinse mouth thoroughly immediately after use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT SECTION Inactive Ingredients: Diatomite, Flavor, Glycerin, Carboxymethyl Cellulose, Phosphoric Acid, Sodium Benzoate, Sodium Saccharin and Purified Water.
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.INDICATIONS & USAGE SECTION Indications and Usage: It is well recognized that regular use of 1.1% Neutral Sodium Fluoride (5000 ppm F) in mouthpiece applicators is safe and effective in preventing caries. 1-4 ProDenRx Brush-On Gel may be applied using a toothbrush. Plaque contributes to caries; therefore, reduction of plaque can help in preventing caries.
Purpose
Information about the drug product’s indications for use.OTC - PURPOSE Clinical Pharmacology: Applying preparations containing high fluoride concentrations on a regular basis increases the fluoride ion levels in tooth enamel and improves tooth resistance to acid dissolution. Indications and Usage: It is well recognized that regular use of 1.1% Neutral Sodium Fluoride (5000 ppm F) in mouthpiece applicators is safe and effective in preventing caries. 1-4 ProDenRx Brush-On Gel may be applied using a toothbrush. Plaque contributes to caries; therefore, reduction of plaque can help in preventing caries. Contraindications: Do not use in children under 6 unless recommended by a dentist. Warnings: PLEASE KEEP OUT OF REACH OF CHILDREN. Children under 6 years old: The potential for fluorosis from repeated swallowing is possible; therefore, children under 6 years old should use only if ordered by dentist and carefully supervised by parent. Precautions: Limited to topical use in mouth only. DO NOT SWALLOW. Overdosage: Swallowing a normal treatment dose (approx. 2 mg of fluoride) is not harmful. Dosage and Administration: Adults and Children over 6 years of age: Use in place of your regular toothpaste. Apply at bedtime or more often if your dentist recommends additional therapy based on the diagnosis. Cover brush head with ProDenRx 1.1% Neutral Sodium Fluoride Gel and brush around all tooth surfaces and gum line for at least 1 minute. Spit out gel. Adults: Wait 30 minutes before rinsing mouth. For children under age 12: Rinse mouth thoroughly immediately after use. Store at Room Temperature How Supplied: Net Wt. 2 oz. (56 g) tube in a box. Cherry Limeade: NDC 59883-821-02 References: 1. Accepted Dental Therapeutics Ed. 40 ADA Chicago, p. 405-407, 1984. 2. Englander HR, et al.: JADA 83:354-358 1971. 3. Englander HR, et al.: JADA 78:783-787 1969. 4. Englander HR, et al.: JADA 75:638-644 1967. Rx Only 1-800-228-5595 REORDER NUMBER: 2250CLM Made for and Distributed in US by: Zila Therapeutics, Inc. P.O. Box 3889, Batesville, AR 72503
Spl product data elements
Usually a list of ingredients in a drug product.Pro-Den Rx Sodium Fluoride DIATOMACEOUS EARTH GLYCERIN CARBOXYMETHYLCELLULOSE PHOSPHORIC ACID SODIUM BENZOATE SACCHARIN SODIUM WATER SODIUM 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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1e7e7d6a-figure-01 1e7e7d6a-figure-02
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
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.OTC - KEEP OUT OF REACH OF CHILDREN SECTION Warnings: PLEASE KEEP OUT OF REACH OF CHILDREN. Children under 6 years old: The potential for fluorosis from repeated swallowing is possible; therefore, children under 6 years old should use only if ordered by dentist and carefully supervised by parent.
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 SECTION Warnings: PLEASE KEEP OUT OF REACH OF CHILDREN. Children under 6 years old: The potential for fluorosis from repeated swallowing is possible; therefore, children under 6 years old should use only if ordered by dentist and carefully supervised by parent. Precautions: Limited to topical use in mouth only. DO NOT SWALLOW. Overdosage: Swallowing a normal treatment dose (approx. 2 mg of fluoride) is not harmful.
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