{"active_ingredient":["Active ingredient Stannous Fluoride 0.4%"],"dosage_and_administration":["Directions Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (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":"20251104","id":"42c89f0a-b4bb-a17b-e063-6294a90a09bf","inactive_ingredient":["Inactive ingredients Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine"],"indications_and_usage":["Uses Helps aid in the prevention of dental cavities."],"keep_out_of_reach_of_children":["Warnings Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M021"],"brand_name":["Plak Smacker"],"generic_name":["STANNOUS FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Young Innovations, Inc."],"package_ndc":["72796-0412-1"],"product_ndc":["72796-0412"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL","ORAL"],"spl_id":["42c89f0a-b4bb-a17b-e063-6294a90a09bf"],"spl_set_id":["e65c62d9-e8a6-3101-e053-2995a90a1494"],"substance_name":["STANNOUS FLUORIDE"],"unii":["3FTR44B32Q"]},"other_safety_information":["Other information Do not use if the foil seal under the cap is torn, cut of missing."],"package_label_principal_display_panel":["Principal Display Panel Home Care Fluoride Gel 0.4% Stannous Fluoride Bubblegum Burst 11422 AIDS IN THE PREVENTION OF DENTAL CAVITIES PLAK SMACKER Net Weight 4.3 oz (121.9 g) plak_bubblegum_image.jpg"],"purpose":["Purpose Anticavity"],"questions":["Questions or comments? 1-800-558-6684"],"set_id":"e65c62d9-e8a6-3101-e053-2995a90a1494","spl_product_data_elements":["Plak Smacker Stannous Fluoride STANNOUS FLUORIDE FLUORIDE ION GLYCERIN ASCORBIC ACID TROLAMINE ANHYDROUS CITRIC ACID CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) Bubblegum Burst"],"version":"3","warnings":["Warnings This is an anticavity fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using."],"when_using":["Warnings When using this product it 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."]}