{"active_ingredient":["Active ingredient (in each 10mL) Sodium fluoride 0.04% (0.02% w/v fluoride ion)"],"dosage_and_administration":["Directions Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision Children under 6 years of age: consult a dentist or doctor"],"effective_time":"20240118","id":"15d5c2e4-8e09-49cf-911c-4894faea2995","inactive_ingredient":["Inactive ingredients water, glycerin, Aloe barbadensis leaf juice organic , xylitol, sodium phosphate, propanediol, benzoic acid, natural flavor, phosphoric acid, menthol, Fragaria ananassa (Strawberry) fruit juice, Ananas sativus (Pineapple) fruit juice, Citrus aurantium dulcis (Orange) juice, Citrus limon (Lemon) juice, Mangifera indica (Mango) juice, Rebaudioside A"],"indications_and_usage":["Use aids in the prevention of dental cavities"],"keep_out_of_reach_of_children":["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"],"openfda":{"application_number":["M021"],"brand_name":["Toms Childrens Anticavity Mouthwash Silly Strawberry"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Tom's of Maine, Inc."],"package_ndc":["51009-840-52"],"product_ndc":["51009-840"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"rxcui":["831877"],"spl_id":["15d5c2e4-8e09-49cf-911c-4894faea2995"],"spl_set_id":["998c6f35-20f4-4cb8-bc48-6aa39e61481a"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"],"upc":["0077326468395"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label SINCE 1970 Tom's OF MAINE ® alcohol-free | natural children's anticavity fluoride rinse cavity protection for a healthy smile tastes great dye free ADA Accepted American Dental Association® silly strawberry 16 FL OZ (473 mL) with real fruit juice! P9937074 IMPORTANT: Read directions for proper use PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label"],"purpose":["Purpose Anticavity"],"questions":["Questions? 1-800-FOR-TOMS (1-800-367-8667)"],"set_id":"998c6f35-20f4-4cb8-bc48-6aa39e61481a","spl_product_data_elements":["Toms Childrens Anticavity Mouthwash Silly Strawberry sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER GLYCERIN PROPANEDIOL XYLITOL SODIUM PHOSPHATE BENZOIC ACID ALOE VERA LEAF LEVOMENTHOL PHOSPHORIC ACID STRAWBERRY JUICE PINEAPPLE JUICE ORANGE JUICE LEMON JUICE MANGO JUICE REBAUDIOSIDE A"],"spl_unclassified_section":["Drug Facts","Dist. by TOM'S OF MAINE, INC., KENNEBUNK, ME 04043 U.S.A."],"version":"10","warnings":["Warnings 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"]}