{"active_ingredient":["OTC - ACTIVE INGREDIENT Neutral Sodium Fluoride 1.1% w/w (5000 ppm F)."],"contraindications":["CONTRAINDICATIONS Do not use in children under 6 unless recommended by a dentist."],"description":["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."],"dosage_and_administration":["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. Berry Fresh: NDC 59883-822-02 Cherry Limeade: NDC 59883-821-02 Cool Mint: NDC 59883-820-02 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: 2250RBM Made for and Distributed in US by: Zila Therapeutics, Inc. P.O. Box 3889, Batesville, AR 72503"],"effective_time":"20130107","id":"cb5a7205-bee9-4b5e-9125-0b910f7f0268","inactive_ingredient":["INACTIVE INGREDIENT Diatomite, Flavor, Glycerin, Carboxymethyl Cellulose, Phosphoric Acid, Sodium Benzoate, Sodium Saccharin and Purified Water."],"indications_and_usage":["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."],"keep_out_of_reach_of_children":["OTC - KEEP OUT OF REACH OF CHILDREN PLEASE KEEP OUT OF REACH OF CHILDREN."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL cb5a7205-figure-01"],"precautions":["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."],"purpose":["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."],"set_id":"aa86f10c-261e-42a2-9f74-a162af141985","spl_product_data_elements":["Pro-Den Rx Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION DIATOMACEOUS EARTH GLYCERIN CARBOXYMETHYLCELLULOSE PHOSPHORIC ACID SODIUM BENZOATE SACCHARIN SODIUM WATER"],"spl_unclassified_section":["Drug Facts"],"version":"4","warnings":["WARNINGS 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."]}