{"active_ingredient":["Active Ingredients: Neutral Sodium Fluoride 1.1% w/w (5000 ppm F)."],"clinical_pharmacology":["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."],"contraindications":["Contraindications: Do not use in children under 6 unless recommended by a dentist."],"dosage_and_administration":["Dosage and Administration: Apply daily at bedtime, in place of your regular toothpaste 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 two minutes. Spit out gel. Adults: Wait 30 minutes before rinsing mouth. Children under 12: Rinse mouth thoroughly immediately after use."],"effective_time":"20151222","how_supplied":["How Supplied: Net Wt. 2 oz. (56 g) tube in a box. Cool Mint: NDC 59883-820-02 Cherry Limeade: NDC 59883-821-02 Reorder 1-800-433-6628 Reorder Number: 2250MTM 965920 Manufactured for Den-Mat Holdings, LLC 1017 W. Central Ave., Lompoc, CA 93436 ©2014 Den-Mat Holdings, LLC. All rights reserved."],"id":"0e66ff22-6fb0-4483-b5f7-da9230f77a63","inactive_ingredient":["Inactive Ingredients: Carboxymethyl cellulose sodium, flavor, glycerin, mica, phosphoric acid, purified water, sodium benzoate, sodium hydroxide, sucralose, titanium dioxide and xylitol."],"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 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":["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":{},"overdosage":["Overdosage: Swallowing a normal treatment dose (approximately 2 mg of fluoride) is not harmful. Store at Room Temperature"],"package_label_principal_display_panel":["Principal Display Panel - Carton Label NDC 59883-820-02 pro-denRx ® dentrifice gel 1.1% PLUS neutral sodium fluoride cool mint flavor Contains: 1.1% sodium fluoride (5000 ppm fluoride ion) in a neutral topical dentifrice gel Net Wt. 2oz. (56 g) DYE-FREE GEL Figure","Principal Display Panel - Tube Label NDC 59883-820-02 1.1% PLUS neutral sodium fluoride pro-denRx ® dentifrice gel cool mint flavor Contains: 1.1% sodium fluoride (5000 ppm fluoride ion) in a neutral topical dentifrice gel Net Wt. 2oz. (56 g) DYE-FREE GEL Figure"],"precautions":["Precautions: Limited to topical use in mouth only. DO NOT SWALLOW."],"purpose":["Description: A homecare, self-applied topical fluoride treatment containing 1.1% Neutral Sodium Fluoride (5000 ppm F) for daily use in the protection against caries."],"set_id":"57080023-c62b-4bbe-a76c-ed7ae576640f","spl_product_data_elements":["Pro-Den Rx Sodium Fluoride Sodium Fluoride Fluoride Ion Sodium Phosphate, Monobasic, Unspecified Form Glycerin Mica Phosphoric Acid Water Sodium Benzoate Sodium Hydroxide Sucralose Titanium Dioxide Xylitol MINT"],"version":"3","warnings":["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."]}