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| Product NDC Code | 58578-0407 | ||||
|---|---|---|---|---|---|
| Drug Name | Closys silver healthy gums |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M022 | ||||
| Labeler Name | Rowpar Pharmaceuticals, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Active ingredient Purpose Cetylpyridinium chloride 0.075 Antigingivitis/Antiplaque
| Cetylpyridinium chloride 0.075 | Antigingivitis/Antiplaque |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
| 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. |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, potassium sorbate, trisodium phosphate, citric acid, sodium benzoate, mint flavor, sucralose, benzoic acid
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Spl product data elements
Usually a list of ingredients in a drug product.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
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call 1-800-643-3337
Storage and handling
Information about safe storage and handling of the drug product.Other Information Do not use if safety seal is broken or missing. This rinse is not intended to replace brushing or flossing
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API