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| Product NDC Code | 58578-0759 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Closys |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | PASTE, DENTIFRICE | ||||||
| RxCUI drug identifier | 1099038 | ||||||
| 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 0.21% (0.11% 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, cellulose gum, disodium hydrogen phosphate, titanium dioxide, peppermint oil, sodium dihydrogen phosphate, sodium myristoyl sarcosinate (coconut derived), 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.USES: 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 SODIUM FLUORIDE FLUORIDE ION WATER HYDRATED SILICA CHLORINE DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS TITANIUM DIOXIDE PEPPERMINT OIL SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS SODIUM MYRISTOYL SARCOSINATE SUCRALOSE MENTHOL, UNSPECIFIED FORM Carton Label Tube Label
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.Packaging GENTLE MINT A CLEANER MOUTH A HEALTHIER YOU ® CLōSYS ® SILVER ® Gentlest. Oral Care. Ever ® for ADULTS 55+ MULTI-BENEFIT TOOTHPASTE Anticavity Protection Remineralizes Enamel Freshens Breath Gentle / Non-irritating ADA Accepted American Dental Association 3.4 oz (96g) ADA Accepted American Dental Association Helps prevent cavities pH balanced Naturally activated for faster results Strengthens Enamel SULFATE-FREE Dist by: Rowpar Pharmaceutical, Inc. Scottsdale, AZ 85260 CloSYS.com 55034-37 MADE IN THE USA GENTLE MINT A CLEANER MOUT A HEALTHIER YOU ® CLōSYS ® SILVER ® Gentlest. Oral Care. Ever ® for ADULTS 55+ MULTI-BENEFIT TOOTHPASTE Anticavity Protection Remineralizes Enamel Freshens Breath Gentle / Non-irritating 3.4 oz (96g) Use of standardized chlorine dioxide is protected under U.S. & foreign patents-see CloSYS.com/patents ADA Accepted American Dental Association Helps prevent cavities Dist by: Rowpar Pharmaceutical, Inc. Scottsdale, AZ 85260 CloSYS.com MADE IN THE USA 54534-56
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 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: 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.
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