{"active_ingredient":["Active ingredient Sodium monofluorophosphate 0.76% (0.15%)w/v fluoride ion)"],"dosage_and_administration":["Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician"],"dosage_and_administration_table":["<table width=\"75%\"><col width=\"30%\" align=\"left\" valign=\"top\"/><col width=\"70%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Toprule\"><td styleCode=\"Botrule\">adults and children 2 years of age and older</td><td styleCode=\"Lrule Botrule\">brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician</td></tr><tr styleCode=\"Botrule\"><td>children 2 to 6 years</td><td styleCode=\"Lrule\">use only a pea sized amount and supervise child&apos;s brushing and rinsing (to minimize swallowing)</td></tr><tr styleCode=\"Botrule\"><td>children under 2 years</td><td styleCode=\"Lrule\">ask a dentist or physician</td></tr></tbody></table>"],"effective_time":"20251229","id":"baaa5bdf-c58a-4b39-a6a6-dda6d98229fa","inactive_ingredient":["Inactive ingredients dicalcium phosphate dihydrate, aqua(water), sorbitol, sodium lauryl sulfate, aroma(flavour), cellulose gum, tetrasodium pyrophosphate, sodium saccharin, limonene"],"indications_and_usage":["Use helps protect against cavities"],"keep_out_of_reach_of_children":["Keep out of the reach of children under 6 years of age. 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":["Gracie Square Hospital Amenity"],"generic_name":["SODIUM MONOFLUOROPHOSPHATE"],"is_original_packager":[true],"manufacturer_name":["ASP Global, LLc"],"package_ndc":["59448-101-00","42555-060-45"],"product_ndc":["59448-101"],"product_type":["HUMAN OTC DRUG"],"rxcui":["545626"],"spl_id":["baaa5bdf-c58a-4b39-a6a6-dda6d98229fa"],"spl_set_id":["89d81053-6950-465e-a5b1-cbf841d7afcb"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 10 g Tube Label Colgate ® Anticavity Toothpaste Cavity Protection NET WT 10g Principal Display Panel - 10 g Tube Label","PRINCIPAL DISPLAY PANEL - Kit Label GRACIE SQUARE HOSPITAL Item #: GSHAMEN01 Description: Amenity Kit PO #: Lot #: XMMDDFC Exp: YYYY-MM-DD Qty: 20 KIT/CS Carton #: X of XX Net Wt.: XX KG Gross Wt.: XX KG Cubic Dimensions: NN x NN x NN CM Assembled in China Components Made in China: Shampoo/Conditioner Body Wash Body Lotion Alcohol-Free Mouthwash Hair Brush Toothbrush Ear Plugs Lip Balm Kit Case Component Made in Thailand: Toothpaste GRACIE SQUARE HOSPITAL We are pleased to present this welcome kit for your comfort and convenience during your stay. Thank you for choosing Gracie Square Hospital for your healthcare! Contents/Origins: 2.0 fl. oz. Shampoo/Conditioner 2.0 fl. oz. Body Wash 2.0 fl. oz. Body Lotion 2.2 fl. oz. Alcohol-Free Mouthwash 0.15 oz. net wt. Lip Balm Hair Brush, Toothbrush, Ear Plugs, and Kit Case: Made in China Toothpaste: Made in Thailand Lot #: Exp: Distributed by: ASP Global, LLC 3450 Atlanta Industrial Parkway Atlanta, GA 30331 GSHAMEN01 Rev 2 GRACIE SQUARE HOSPITAL Principal Display Panel - Kit Label"],"purpose":["Purpose Anticavity"],"questions":["Questions or comments? Call toll-free 1-800-468-6502"],"set_id":"89d81053-6950-465e-a5b1-cbf841d7afcb","spl_product_data_elements":["Gracie Square Hospital Amenity Sodium Monofluorophosphate Colgate Anticavity Sodium Monofluorophosphate Sodium Monofluorophosphate Fluoride Ion Dibasic Calcium Phosphate Dihydrate Water Sorbitol Sodium Lauryl Sulfate Sodium Pyrophosphate Saccharin Sodium Gilchrist and Soames Body Butter Water ISOPROPYL PALMITATE CETOSTEARYL ALCOHOL GLYCERYL MONOSTEARATE CYCLOMETHICONE 5 ISOPROPYL MYRISTATE BENZYL ALCOHOL PEG-100 MONOSTEARATE CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) DEHYDROACETIC ACID SODIUM HYDROXIDE WHITE Gilchrist and Soames Hair 2 in 1 Water SODIUM LAURETH-3 SULFATE SODIUM CHLORIDE GLYCERIN COCAMIDOPROPYL BETAINE COCO MONOETHANOLAMIDE POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) CITRIC ACID MONOHYDRATE MAGNESIUM NITRATE METHYLCHLOROISOTHIAZOLINONE MAGNESIUM CHLORIDE METHYLPARABEN PROPYLPARABEN METHYLISOTHIAZOLINONE FD&C YELLOW NO. 5 FD&C RED NO. 4 YELLOW Gilchrist and Soames Body Refresher--Body Wash Water SODIUM LAURETH-3 SULFATE SODIUM CHLORIDE COCAMIDOPROPYL BETAINE GLYCERIN POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) COCO MONOETHANOLAMIDE MAGNESIUM NITRATE CITRIC ACID MONOHYDRATE METHYLCHLOROISOTHIAZOLINONE MAGNESIUM CHLORIDE METHYLISOTHIAZOLINONE FD&C YELLOW NO. 5 FD&C RED NO. 4 FD&C BLUE NO. 1 GREEN Gilchrist and Soames Moisturizing Lip Balm CERESIN ETHYLHEXYL PALMITATE MINERAL OIL PETROLATUM HYDROGENATED POLYBUTENE (1300 MW) POLYBUTENE (1400 MW) MICROCRYSTALLINE WAX CANDELILLA WAX SILICON DIOXIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PROPYLPARABEN FD&C YELLOW NO. 5 ACID BLUE 9 AMMONIUM YELLOW ASP Global, LLc Alcohol-Free Water GLYCERIN POLYSORBATE 20 SODIUM BENZOATE MENTHOL, UNSPECIFIED FORM SACCHARIN SODIUM CETYLPYRIDINIUM CHLORIDE FD&C BLUE NO. 1 BLUE"],"spl_unclassified_section":["Colgate ® Anticavity Toothpaste Drug Facts","Manufactured by: COLGATE-PALMOLIVE (THAILAND) Limited, Chonburi 20000, Thailand."],"version":"6","warnings":["Warnings Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."]}