{"active_ingredient":["Active ingredient Active ingredient Purpose Cetylpyridinium chloride 0.075 Antigingivitis/Antiplaque"],"active_ingredient_table":["<table cellpadding=\"4\" width=\"50%\"><colgroup><col/><col align=\"right\"/></colgroup><tbody><tr><td><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredient</content></content></td><td align=\"right\"><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></td></tr><tr><td>Cetylpyridinium chloride 0.075</td><td align=\"right\">Antigingivitis/Antiplaque</td></tr></tbody></table>"],"dosage_and_administration":["Directions Adults and children 12 years and over Vigorously swish 20 milliliters of rinse between your teeth for 30 seconds and then spit out. Do not swallow rinse. Children 6 years to under 12 years Supervise use. Children under 6 years Do not use."],"dosage_and_administration_table":["<table cellpadding=\"4\" width=\"70%\"><colgroup><col width=\"30%\"/><col/></colgroup><tbody><tr><td colspan=\"2\"><content styleCode=\"bold\"><content styleCode=\"italics\">Directions</content></content></td></tr><tr><td styleCode=\"Rrule Toprule\" valign=\"top\">Adults and children 12 years and over</td><td styleCode=\"Toprule\">Vigorously swish 20 milliliters of rinse  between your teeth for 30 seconds and  then spit out. Do not swallow rinse.</td></tr><tr><td styleCode=\"Rrule Toprule\">Children 6 years to  under 12 years</td><td styleCode=\"Toprule\" valign=\"top\">Supervise use.</td></tr><tr><td styleCode=\"Rrule Toprule\">Children under  6 years</td><td styleCode=\"Toprule\" valign=\"top\">Do not use.</td></tr></tbody></table>"],"effective_time":"20260401","id":"452e539e-8d6e-4150-832b-c8f6760086eb","inactive_ingredient":["Inactive ingredients water, potassium sorbate, trisodium phosphate, citric acid, sodium benzoate, mint flavor, sucralose, benzoic acid"],"indications_and_usage":["Uses Helps prevent and reduce plaque and gingivitis. Helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums."],"keep_out_of_reach_of_children":["Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M022"],"brand_name":["CloSYS Silver Healthy Gums"],"generic_name":["CETYLPYRIDINIUM CHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Rowpar Pharmaceuticals, Inc."],"package_ndc":["58578-0407-1","58578-0407-2","58578-0407-3","58578-0407-4"],"product_ndc":["58578-0407"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["452e539e-8d6e-4150-832b-c8f6760086eb"],"spl_set_id":["11fd3f31-ee0c-43d2-a856-929d1298277c"],"substance_name":["CETYLPYRIDINIUM CHLORIDE"],"unii":["D9OM4SK49P"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Non-Burning, Non-Irritating Formula A CLEANER MOUTH A HEALTHIER YOU ® ClōSYS ® Antigingivitis/Antiplaque Mouth Rinse HEALTHY GUMS SENSITIVE MOUTH RINSE KILLS GERMS THAT CAUSE GINGIVITIS, PLAQUE & BAD BREATH Helps Reverse Early Signs of Gum Disease Freshens Breath Non Burning, Alcohol Free Gentle Mint 32 fl oz (946 mL) Our Story Founder of CloSYS ® & Periodontist Dr. Perry Ratcliff had a bold belief that there had to be a better/gentler way to help with oral care. Dr. Ratcliff didn’t agree with the common myth ‘If it hurts, it must be good for you.’ CloSYS ® took a different approach―keep it gentle, yet effective, and people will use it long enough to make a difference in their oral health. After discovering that his first patented formula was not only extremely gentle but incredibly effective, he gathered a small group of dental professionals and business leaders to start their journey toward what is today Founder of CloSYS ® Oral Care. What Makes CloSYS ® Products Different? Simply put, CloSYS ® is the Gentlest, Oral Care. Ever. ® All CloSYS ® formulas are highly effective and extremely gentle so they are not harsh or irritating to sensitive mouths. And because it’s so gentle, it means you can swish it in your mouth longer without having to spit it out early and risk not getting the full benefit of the rinse. CloSYS ® products are free of alcohol, sulfates, triclosan, and other harsh ingredients that can burn or irritate sensitive mouths. How Does CloSYS ® Healthy Gums Work? CloSYS ® Healthy Gums Oral Rinse kills germs that cause gingivitis, plaque and bad breath and helps reverse early signs of gum disease (redness, bleeding and inflammation). Its gentle formula protects against plaque formation that oftens leads to gingivitis, while the gentle mint flavor freshens breath. And, the formula doesn’t contain alcohol, sulfates, triclosan, and other ingredients that can burn or irritate the mouth or gums so you can rinse longer and get great results! HEALTHY Mouth= HEALTHY Body Gentlest. Oral Care. Ever. ® Distributed by: Rowpar Pharmaceuticals, Inc. Bridgewater, NJ 08807 1(800) 643-3337 closys.com This bottle is recyclable. Please support recycling in your community. 55002-44 A CLEANER MOUTH A HEALTHIER YOU ® ClōSYS Antigingivitis/Antiplaque Mouth Rinse HEALTHY GUMS SENSITIVE MOUTH RINSE KILLS GERMS THAT CAUSE GINGIVITIS, PLAQUE & BAD BREATH Helps Reverse Early Signs of Gum Disease Freshens Breath Non Burning , Alcohol Free Gentle Mint 32 fl oz (946 mL) 52532-85 Distributed by: Rowpar Pharmaceuticals, Inc. Bridgewater, NJ 08807 1(800) 643-3337 closys.com This bottle is recyclable. Please support recycling in your community. 52532-86"],"purpose":[""],"questions":["Questions or comments? call 1-800-643-3337"],"set_id":"11fd3f31-ee0c-43d2-a856-929d1298277c","spl_product_data_elements":["CloSYS Silver Healthy Gums Cetylpyridinium Chloride Cetylpyridinium Chloride Cetylpyridinium Water Potassium Sorbate Sodium Phosphate, Tribasic, Dodecahydrate Anhydrous Citric Acid Sodium Benzoate Mint Sucralose Benzoic Acid Label Carton"],"storage_and_handling":["Other Information Do not use if safety seal is broken or missing. This rinse is not intended to replace brushing or flossing"],"version":"5","warnings":["Warnings Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease."]}