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| Product NDC Code | 58578-0517 | ||||
|---|---|---|---|---|---|
| Drug Name | Closys silver sensitive mouth rinse fluoride rinse |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | RINSE | ||||
| RxCUI drug identifier | 313029 | ||||
| Application Number | M021 | ||||
| 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 Sodium fluoride 0.02% (0.01% w/v fluoride ion)
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 6 years of age and older use twice a day after brushing your teeth with a toothpaste pour out and 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 consult a dentist or doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, Cloralstan ® (stabilized chlorine dioxide), trisodium phosphate, citric acid, peppermint flavor, sucralose
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 ▪ Aids in the prevention of dental cavities
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION WATER CHLORINE DIOXIDE SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE ANHYDROUS CITRIC ACID PEPPERMINT SUCRALOSE 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 ClōSYS ® SILVER ® Anticavity Fluoride Mouth Rinse HEALTHY TEETH SENSITIVE MOUTH RINSE WITH FLUORIDE HELPS REBUILD WEAKENED TOOTH ENAMEL & REVERSE EARLY TOOTH DECAY Protects Against Cavities Freshens Breath Non Burning, Alcohol Free Gentle pH Balanced Gentle Mint 32 fl oz (946 mL) 52532-32 Distributed by: Rowpar Pharmaceuticals, Inc. Bridgewater, NJ 08807 1 (800) 643-3337 closys.com This bottle is recyclable. Please support recycling in your community 52532-33 Non-Burning, Non-Irritating Formula A CLEANER MOUTH A HEALTHIER YOU ® ClōSYS ® SILVER ® Anticavity Fluoride Mouth Rinse HEALTHY TEETH SENSITIVE MOUTH RINCE WITH FLUORIDE HELPS REBUILD WEAKENED TOOTH ENAMEL & REVERSE EARLY TOOTH DECAY Protects Against Cavities Freshens Breath Non Burning, Alcohol Free Gentle pH Balanced Gentle Mint 32 fl oz (946 mL) A CLEANER MOUTH A HEALTHIER YOU ® ClōSYS ® SILVER ® Serious Science for Sensitive Mouths ™ How does CloSYS ® Silver with Flouride Work? CloSYS ® Silver Healthy Teeth Mouth Rinse contains fluoride to help protect against cavities. With regular use, it helps rebuild weakened tooth enamel, reverse early tooth decay, and strengthen teeth to improve their appearance. The patented dual action formula contains Cloralstan® which kills bad breath bacteria and neutralizes sulfur mouth odor molecules for long lasting fresh breath. CloSYS® Silver Healthy Teeth Mouth Rinse does not contain alcohol, sulfates, triclosan, and other ingredients that can burn or irritate the mouth so you can rinse longer to get great results! HEALTHY Mouth = HEALTHY Body Gentlest. Oral Care. Ever. ® A CLEANER MOUTH A HEALTHIER YOU ® ClōSYS ® SILVER ® Serious Science for Sensitive Mouths ™ 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 CloSYS® Oral Care. What Makes CloSYS ® Product 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. Distributed by: Rowpar Pharmaceuticals, Inc. Bridgewater, NJ 08807 1 (800) 643-3337 closys.com This bottle is recyclable. Please support recycling in your community 55032-42
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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
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