{"active_ingredient":["OTC - ACTIVE INGREDIENT Active Ingredients: Neutral Sodium Fluoride 1.1% w/w (5000 ppm F). Contains: 1.1% Sodium Fluoride (5000 ppm Fluoride Ion)"],"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 in the protection against dental caries."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply daily after usual brushing and flossing at bedtime or more often if your dentist recommends additional therapy based on your diagnosis. Cover brush head with Pro-DenRx 1.1% Neutral Sodium Fluoride Gel and brush around all tooth surfaces and gum line for at least one minute. Spit out gel. Adults: Wait 30 minutes before rinsing mouth; Children under 12: Immediately after use, rinse mouth thoroughly with water. When using a mouthpiece or applicator, cover the inner surface with gel. Place applicator in mouth and bite down lightly for at least 1 minute. Remove applicator and rinse mouth. Clean applicators with cold water. Store at Room Temperature"],"effective_time":"20140103","how_supplied":["HOW SUPPLIED Net Wt. 2 oz. (56 g) tube in a box. Cherry Limeade: NDC 59883-825-02 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: 2240CLM 442246 Rev. 1 1008 Made for and Distributed in US by: Zila Therapeutics, Inc. P.O. Box 3889, Batesville, AR 72503"],"id":"b6760df0-a47e-4365-a871-bd6fd95012f7","inactive_ingredient":["INACTIVE INGREDIENT Inactive Ingredients: Flavor, hydroxyethyl cellulose, sucralose, 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 Pro-DenRx Brush-On Gel can be applied on a toothbrush as well as a mouthpiece tray. 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 Warnings: 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."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL b6760df0-figure-01 b6760df0-figure-02"],"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":"2891b2c0-fd7b-4c73-bb60-1ff292a22459","spl_product_data_elements":["Pro-Den Rx Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION HYDROXYETHYL CELLULOSE (140 CPS AT 5%) SUCRALOSE WATER"],"spl_unclassified_section":["Neutral Sodium Fluoride Topical Gel – Dye Free Gel"],"version":"3","warnings":["WARNINGS Precautions: Limited to topical use in mouth only. DO NOT SWALLOW. Overdosage: Swallowing a normal treatment dose (approximately 2 mg of fluoride) is not harmful."]}