Active Ingredient
Sodium fluoride 0.24% (0.13% w/v fluoride ion)
Closys Paste, Dentifrice
FDA Label NDC 58578-0749
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 58578-0749). 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 active ingredient, purpose, use, otc - keep out of reach of children, directions, inactive ingredients, questions or comments?, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Use
aids in the prevention of dental cavities
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 sodium lauroyl sarcosinate, disodium hydrogen phosphate, cellulose gum, titanium dioxide, peppermint oil, sodium dihydrogen phosphate, sucralose, menthol crystals
Questions Or Comments?
call 1-800-643-3337
Principal Display Panel
Gentle MINT FLAVOR
ADA Accepted
American Dental Association
CloSYS®
SULFATE-FREE FLUORIDE TOOTHPASTE
NET WT. 7.0 oz (198g)
Non-Irritating: for Sensitive Mouths
A Cleaner Mouth.
A Healthier You.
* Please review the disclaimer below.
