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| Product NDC Code | 58578-0749 | ||||||||
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| Drug Name | Closys |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | DENTAL, ORAL | ||||||||
| Dosage Form | PASTE, DENTIFRICE | ||||||||
| RxCUI drug identifier | 416783 | ||||||||
| 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 0.24% (0.13% 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 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 doctor. children under 6 years of age: instruct in good brushing and rinsing habits (to minimize swallowing). supervise children as necessary until capable of using without supervision. do not swallow children under 2 years of age: consult a dentist or doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: water, hydrated silica, stabilized chlorine dioxide, sarkosyl (coconut derived), disodium hydrogen phosphate, cellulose gum, titanium dioxide, peppermint oil, sodium dihydrogen phosphate, sucralose, menthol crystals
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.USE: Aids in the prevention of dental decay.
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 Sodium Fluoride SUCRALOSE SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS SODIUM PHOSPHATE, DIBASIC, ANHYDROUS CARBOXYMETHYLCELLULOSE WATER TITANIUM DIOXIDE HYDRATED SILICA CHLORINE DIOXIDE SODIUM FLUORIDE FLUORIDE ION PEPPERMINT OIL PEPPERMINT MENTHOL SODIUM LAUROYL SARCOSINATE 7 carton 3.4 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.Principal Display Panel Closys ® Anticavity Fluoride Toothpaste SULFATE-FREE NEW LOOK! A CLEANER MOUTH A HEALTHIER YOU ® CLoSYS ® Anticavity Fluoride Toothpaste SENSITIVE TOOTHPASTE WITH FLUORIDE NON-IRRITATING SULFATE-FREE HELPS REBUILD WEAKEND TOOTH ENAMEL Protects Against Cavities Freshens Breath Non-Irritating Formula Gentle Mint 7oz (196g) NON-IRRITATING SULFATE-FREE pH balanced Fights Cavities Strengthens Enamel Closys ® Anticavity Fluoride Toothpaste SENSITIVE TOOTHPASTE WITH FLUORIDE NON-IRRITATING SULFATE-FREE HELPS REBUILD WEAKEND TOOTH ENAMEL Protects Against Cavities Freshens Breath Non-Irritating Formula Gentle Mint 7oz (196g) Closys ® Anticavity Fluoride Toothpaste SULFATE-FREE NEW LOOK! A CLEANER MOUTH A HEALTHIER YOU ® CLoSYS ® Anticavity Fluoride Toothpaste SENSITIVE TOOTHPASTE WITH FLUORIDE NON-IRRITATING SULFATE-FREE HELPS REBUILD WEAKEND TOOTH ENAMEL Protects Against Cavities Freshens Breath Non-Irritating Formula Gentle Mint 3.4oz (96g) NON-IRRITATING SULFATE-FREE pH balanced Fights Cavities Strengthens Enamel Closys ® Anticavity Fluoride Toothpaste SENSITIVE TOOTHPASTE WITH FLUORIDE NON-IRRITATING SULFATE-FREE HELPS REBUILD WEAKEND TOOTH ENAMEL Protects Against Cavities Freshens Breath Non-Irritating Formula Gentle Mint 3.4oz (96g)
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.Use of stabilized chlorine dioxide is protected under U.S. & foregin patents-see CloSYS.com/patents
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 brushing 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
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