Closys Paste, Dentifrice
FDA Label NDC 58578-0759
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rowpar Pharmaceuticals, Inc. for the product Closys (NDC 58578-0759). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium fluoride 0.21% (0.11% w/v fluoride ion)
Purpose
Anticavity
Uses
aids in the prevention of dental cavities
Warnings
Otc - Keep Out Of Reach Of Children
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.
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) |
| children under 2 years of age consult a dentist or doctor | supervise children as necessary until capable of using without supervision do not swallow |
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
Questions Or Comments?
call 1-800-643-3337
Packaging
Closlvr2 (Silver 2)
Closil1 (Silver1)
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