{"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. Do not use in pediatric patients under 12 unless directed by a dentist or physician."],"description":["DESCRIPTION Ionite H Neutral Fluoride Gel is a flavored, pH neutral 1.1% sodium fluoride, 5% potassium nitrate gel that aids in the prevention of dental decay and hleps to treat sensitive teeth."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Use twice per day (morning and evening) in place of regular toothpaste or as recommended by a dentist or physician. Adults and children 12 years of age and older: Twist off cap and remove foil seal. Apply at least a 1 inch strip gel onto a soft bristle tooth brush. Brush teeth thoroughly for at least 1 minute, spit out, and rinse mouth thoroughly. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: consult a dentist or physician."],"dosage_forms_and_strengths":["DOSAGE FORMS AND STRENGTHS Gel containing 1.1% sodium fluoride and 5% potassium nitrate."],"effective_time":"20150802","how_supplied":["HOW SUPPLIED/STORAGE 4.3 ounces (122 g) in a plastic tube. Store at room temperature 59 – 86°F (15 – 30°C)."],"id":"0b21c890-82f5-4e90-8aa1-1e06d631760e","inactive_ingredient":["INACTIVE INGREDIENTS Alpha-tocopheryl, carbopol, edetic acid, flavor, glycerin, sodium hydroxide, sodium polymetaphosphate, tricalcium phosphate, water, xylitol"],"indications_and_usage":["INDICATIONS AND USAGE This is a fluoride and potassium nitrate gel intended to aid in the prevention of dental decay and to help treat tooth sensitivity to cold, heat, sweets, acids, or contact."],"openfda":{"brand_name":["Ionite H"],"generic_name":["SODIUM FLUORIDE, POTASSIUM NITRATE"],"is_original_packager":[true],"manufacturer_name":["Dharma Research, Inc."],"package_ndc":["53045-280-04"],"product_ndc":["53045-280"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["DENTAL"],"rxcui":["637365"],"spl_id":["0b21c890-82f5-4e90-8aa1-1e06d631760e"],"spl_set_id":["54c1a27c-5936-4ee2-a419-3891d3df9745"],"substance_name":["SODIUM FLUORIDE","POTASSIUM NITRATE"],"unii":["8ZYQ1474W7","RU45X2JN0Z"]},"package_label_principal_display_panel":["Ionite H NDC 53045-280-04 Home Care 1.1% Neutral Fluoride Gel with Xylitol and Vitamin E Spearmint Rx Only Made in USA Gluten Free Dye Free Re-order#: 56-00140 4.3 oz. (122 g) 20150802 280 NaFKNO3 Spmnt RevA"],"set_id":"54c1a27c-5936-4ee2-a419-3891d3df9745","spl_product_data_elements":["Ionite H Sodium Fluoride, Potassium Nitrate SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE NITRATE ION .ALPHA.-TOCOPHEROL CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) EDETIC ACID GLYCERIN SODIUM HYDROXIDE SODIUM POLYMETAPHOSPHATE TRICALCIUM PHOSPHATE WATER XYLITOL"],"spl_unclassified_section":["Ionite H Neutral Fluoride Gel, Sodium Fluoride, 1.1%, Potassium Nitrate, 5%, oral gel","ACTIVE INGREDIENTS Sodium Fluoride, 1.1%; Potassium Nitrate, 5%","Manufactured by Dharma Research, Inc. www.dharmaresearch.com 5220 N.W. 72 Avenue, Unit 15 Miami, FL 33166 1-877-833-3725"],"version":"1","warnings_and_cautions":["WARNINGS AND PRECAUTIONS Do not swallow. Keep out of reach of children. Read prescribing information fully before using this product. If product is accidentially swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product for longer than 4 weeks unless recommended by a dentist or physician."]}