FDA Label for Pro-den Rx
View Indications, Usage & Precautions
Pro-den Rx Product Label
The following document was submitted to the FDA by the labeler of this product Den-mat Holdings, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
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
Package Label.Principal Display Panel
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