{"active_ingredient":["Active Ingredient: Sodium Fluoride 0.2% w/w (0.09% w/w fluoride ion)."],"adverse_reactions":["Adverse Reactions: NONE"],"clinical_pharmacology":["Clinical Pharmacology: Sodium fluoride when used topically promotes remineralization, increases resistance of teeth to acid dissolution, and impedes the cariogenic microbial process."],"contraindications":["Contraindications: Do not use in children under age 6 years unless recommended by a dentist or physician."],"description":["Description: Pro-DenRx ® Neutral Sodium Fluoride Rinse is a neutral, aqueous solution."],"dosage_and_administration":["Dosage and Administration: Adults and children over age 6 years: Rinse once a week, preferably at bedtime, after thoroughly brushing and flossing teeth. Rinse more often if your dentist recommends additional therapy based on your diagnosis. Pour 10 ml (2 teaspoons) of Pro-DenRx® 0.2% Sodium Fluoride Rinse into the graduated cup using the markings on its side. Swish vigorously around and between the teeth for one minute, then spit out. DO NOT SWALLOW. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes after use. Children 6 to 12 years old: Supervise while using this product. Children Under 6 years old: Consult your dentist or doctor before using."],"effective_time":"20190228","general_precautions":["General: Not for systemic treatment. DO NOT SWALLOW."],"how_supplied":["How Supplied: For home use: Plastic bottle containing 16 fl. oz. (473 ml) Cool Mint: NDC 59883-920-16. RX only: Storage: Store at Room Temperature Reorder 1-800-433-6628 Manufactured for Den-Mat Holdings, LLC 1017 W. Central Ave. Lompoc, CA 93436 ©2014 Den-Mat Holdings, LLC. All rights reserved."],"id":"82f8dd55-36df-0de0-e053-2991aa0a6bbf","inactive_ingredient":["Inactive Ingredients: Purified water, Cetyl Pyridinium Chloride, citric acid, potassium sorbate, sucralose, flavor and Sodium Hydroxide."],"indications_and_usage":["Indications and Usage: Aids in the prevention of dental caries. May be used more than once a week if recommended by your dentist. Pro-DenRx ® Rinse is ready to use, convenient and thus increases compliance. Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental cares in adults and children. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis."],"keep_out_of_reach_of_children":["PLEASE KEEP OUT OF REACH OF CHILDREN. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. READ DIRECTIONS CAREFULLY BEFORE USING."],"openfda":{"brand_name":["Pro-Den Rx"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Den-mat Holdings, Llc"],"package_ndc":["59883-920-16","59883-922-16"],"product_ndc":["59883-920","59883-922"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["562510","1488074"],"spl_id":["82f8dd55-36df-0de0-e053-2991aa0a6bbf"],"spl_set_id":["e39b19f7-2b3e-4c77-9544-623ebad84870"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"overdosage":["Overdosage: Swallowing a normal treatment dose (approximately 9 mg. of fluoride) is not harmful."],"package_label_principal_display_panel":["Principal Display Panel - Bottle Label NDC 59883-920-16 pro-denRx ® dye free rinse 0.2% sodium fluoride mint flavor Contains: 0.2% Sodium Fluoride in a Neutral Aqueous Solution (0.09% Fluoride Ion) 16 fl. oz. (473 ml) Principal Display Panel - Bottle Label","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Image not available"],"precautions":["Precautions: General: Not for systemic treatment. DO NOT SWALLOW."],"set_id":"e39b19f7-2b3e-4c77-9544-623ebad84870","spl_product_data_elements":["Pro-Den Rx Sodium Fluoride WATER CETYLPYRIDINIUM CHLORIDE CITRIC ACID MONOHYDRATE POTASSIUM SORBATE SUCRALOSE SODIUM HYDROXIDE SODIUM FLUORIDE FLUORIDE ION MINT Pro-Den Rx Sodium Fluoride WATER CETYLPYRIDINIUM CHLORIDE CITRIC ACID MONOHYDRATE POTASSIUM SORBATE SUCRALOSE SODIUM HYDROXIDE SODIUM FLUORIDE FLUORIDE ION BERRY"],"storage_and_handling":["Storage: Store at Room Temperature Reorder 1-800-433-6628 Manufactured for Den-Mat Holdings, LLC 1017 W. Central Ave. Lompoc, CA 93436 ©2014 Den-Mat Holdings, LLC. All rights reserved."],"version":"7","warnings":["Warnings: PLEASE KEEP OUT OF REACH OF CHILDREN. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. READ DIRECTIONS CAREFULLY BEFORE USING."]}