{"active_ingredient":["Active Ingredient Stannous fluoride, 0.4%"],"do_not_use":["Do not swallow."],"dosage_and_administration":["Directions • This is not a toothpaste. Read directions carefully before using. • Adults and children 6 years of age and older: o Use once per day after brushing teeth thoroughly with toothpaste o Twist off cap to remove foil seal o Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces. o Allow the gel to remain on your teeth for 1 minute o Spit out. Do not swallow o Do not eat, drink, or rinse for at least 30 minutes • Children under 6: consult a dentist or doctors"],"effective_time":"20231011","id":"91060eb1-2d2e-4100-912f-05e7b46c9ae3","inactive_ingredient":["Inactive Ingredients Carbopol, citric acid, flavor, glycerin, sodium hydroxide, water, xylitol"],"indications_and_usage":["Uses Aids in the prevention of dental cavities (caries)."],"keep_out_of_reach_of_children":["Keep out of reach of children. If more that used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M021"],"brand_name":["Ionite H"],"generic_name":["STANNOUS FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Dharma Research, Inc."],"package_ndc":["53045-271-04"],"product_ndc":["53045-271"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"rxcui":["237847"],"spl_id":["91060eb1-2d2e-4100-912f-05e7b46c9ae3"],"spl_set_id":["042636cf-8b61-4022-b0a1-af09c06b145b"],"substance_name":["STANNOUS FLUORIDE"],"unii":["3FTR44B32Q"]},"package_label_principal_display_panel":["Ionite H NDC 53045-271-04 Home Care 0.4% Stannous Fluoride Gel with Xylitol Anticavity Fluoride Preventative Treatment Gel Bubble Gum Made in USA Gluten Free Dye Free Reorder#: 56-00131 4.3 oz. (122 g) 20150802 271 SnF2 BubGm revB"],"purpose":["Purpose Anticavity"],"set_id":"042636cf-8b61-4022-b0a1-af09c06b145b","spl_product_data_elements":["Ionite H Stannous Fluoride STANNOUS FLUORIDE FLUORIDE ION CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) CITRIC ACID MONOHYDRATE GLYCERIN SODIUM HYDROXIDE WATER XYLITOL"],"spl_unclassified_section":["Other Information Store at room temperature 59 – 86°F (15 – 30°C) This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist","Manufactured by Dharma Research, Inc. www.dharmaresearch.com 5220 N.W. 72 Avenue, Unit 15 Miami, FL 33166 1-877-833-3725"],"version":"2","warnings":["Warnings Keep out of reach of children. If more that used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not swallow. Supervision of children is required when using this product. Developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed.","Supervision of children is required when using this product. Developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed."]}