{"adverse_reactions":["ADVERSE REACTIONS To report suspected adverse reactions, contact Dharma Research, Inc. at 1-877-833-3725 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch"],"contraindications":["CONTRAINDICATIONS Avoid use in patients with known hypersensitivity to fluoride"],"description":["DESCRIPTION Ionite R Fluoride Oral Rinse is a flavored, pH neutral 2.0% sodium fluoride treatment rinse that aids in the prevention of dental decay. ACTIVE INGREDIENT: Sodium Fluoride, 2.0% INACTIVE INGREDIENTS: Flavor, Water, Sodium Benzoate, Sodium Citrate, Saccharin Sodium, Xylitol"],"dosage_forms_and_strengths":["DOSAGE FORM AND STRENGTH Liquid containing 2% sodium fluoride"],"effective_time":"20201106","how_supplied":["HOW SUPPLIED/STORAGE 64 fluid ounces (1.9 L) in a plastic bottle with dispensing pump included. Store at room temperature 59-86°F (15-30°C). Protect from freezing."],"id":"87ff143d-62ff-4b12-8800-ca730c2dce0a","indications_and_usage":["INDICATIONS AND USAGE This is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. Remove cap from bottle and insert enclosed pump into bottle and tighten. Pump ½ oz into a cup. Instruct patient to thoroughly rinse the entire amount around and between teeth for one minute, then spit-out rinse. Repeat the procedure to ensure maximum benefit. Instruct patient not to eat or drink for at least 30 minutes."],"openfda":{"brand_name":["Ionite R"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Dharma Research, Inc."],"package_ndc":["53045-266-64"],"product_ndc":["53045-266"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["DENTAL","ORAL"],"rxcui":["251960"],"spl_id":["87ff143d-62ff-4b12-8800-ca730c2dce0a"],"spl_set_id":["1009afc7-6e9d-417f-a702-f8a941e08484"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"],"upc":["0353045001021"]},"package_label_principal_display_panel":["Ionite R Sodium Fluoride Rinse 2.0% Neutral Sodium Fluoride Dye Free Fruit Punch With Xylitol Gluten Free Rx Only 64 fl. oz. (1.9 L) Manufactured by: Dharma Research, Inc., 5220 NW 72nd Avenue, Unit 15, Miami, FL, 33166 1-877-833-3725 www.dharmaresearch.com NDC 53045-266-64 Label Revision B, 10/29/13 20131101 266 Fuoride Rinse Fruit Punch"],"set_id":"1009afc7-6e9d-417f-a702-f8a941e08484","spl_product_data_elements":["Ionite R Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION Water SODIUM BENZOATE SODIUM CITRATE SACCHARIN SODIUM XYLITOL"],"version":"2","warnings_and_cautions":["WARNINGS AND PRECAUTIONS Do not swallow. Keep out of reach of children. Read prescribing information fully before using this product. Use in children less than 6 years of age requires special supervision to prevent swallowing. If product is accidentally swallowed in quantities greater than would normally occur with a rinse, seek medical help right away."]}