CloSYS
CloSYS SILVER Gentle Fluoride TOOTHPASTE
ed617c7a-805c-4788-9bce-9b7fead4312d
HUMAN OTC DRUG LABEL
May 16, 2025
Rowpar Pharmaceuticals, Inc.
DUNS: 783704661
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
INDICATIONS & USAGE SECTION
USES:
aids in the prevention of dental decay
SPL UNCLASSIFIED SECTION
** Drug Facts**
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT:
Sodium fluoride 0.21% (0.11% w/v fluoride ion)
OTC - PURPOSE SECTION
PURPOSE:
Anticavity
WARNINGS SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
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
OTC - QUESTIONS SECTION
Questions or comments?
Call 1-800-643-3337